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	<title>IT Strategy Archivi - NL42 | Paperless Lab Academy®</title>
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		<title>AGQ Labs moves its data driven laboratories strategy to the next level</title>
		<link>https://www.nl42.com/agq-labs-moves-its-data-driven-laboratories-strategy-to-the-next-level/</link>
		
		<dc:creator><![CDATA[Isabel Munoz]]></dc:creator>
		<pubDate>Tue, 23 Nov 2021 18:39:22 +0000</pubDate>
				<category><![CDATA[Digital Transformation]]></category>
		<category><![CDATA[IT Strategy]]></category>
		<category><![CDATA[Lab4.0]]></category>
		<guid isPermaLink="false">https://www.nl42.com/?p=3737</guid>

					<description><![CDATA[<p>AGQ Labs digital transformation strategy aims for laboratory 4.0 AGQ Labs is a chemical technological center, with 25 years of experience. It offers solutions and services for agri-food, environmental, industrial, and mining sectors. All Laboratories are accredited under ISO17025 and equipped with the most advanced technology. They specialise in developing robust and competitive analytical methods [&#8230;]</p>
<p>L'articolo <a href="https://www.nl42.com/agq-labs-moves-its-data-driven-laboratories-strategy-to-the-next-level/">AGQ Labs moves its data driven laboratories strategy to the next level</a> proviene da <a href="https://www.nl42.com">NL42 | Paperless Lab Academy®</a>.</p>
]]></description>
										<content:encoded><![CDATA[<h2><span style="color: #666699;">AGQ Labs digital transformation strategy aims for laboratory 4.0</span></h2>
<p><a href="https://agqlabs.es/">AGQ Labs</a> is a chemical technological center, with 25 years of experience. It offers solutions and services for agri-food, environmental, industrial, and mining sectors.</p>
<p>All Laboratories are accredited under ISO17025 and equipped with the most advanced technology. They specialise in developing robust and competitive analytical methods for each of every market they serve, along with strong focus on the corresponding local and international compliances requirements.</p>
<h2><span style="color: #666699;">AGQ labs chooses NL42 to reach next level of standardisation and efficiency </span></h2>
<p>AGQ Labs is launching several initiatives for implementing their digital transformation strategy and reach their Lab 4.0 vision of the future. The scope is to streamline the complete production line, from sample reception to final results to the customer, and  to incorporate latest technologies and methodologies. It should ease remote processes like sample collection in the field. Additionally it should add speed and control along the data workflow.</p>
<blockquote><p>“We believe this project will take us to higher level of standardisation and efficiency. it will empower fall our laboratories over the globe  in delivering best quality services to our customers. We are confident in going through this journey with the support of NL42 consulting. The ultimate goal of the journey is to reach paperless processes and benefit from the advantages that this brings in terms of performance and productivity, quality and compliance” says Antonio Belmonte Corporate Director of Production and Quality at AGQ Labs.</p></blockquote>
<p>AGQ Labs, <a href="https://agqlabs.es/" target="_blank" rel="noopener">agqlabs.es</a> deliver sustainable and scientifically backed solutions tailored to their customer needs though and extensive international network of laboratories and commercial offices.</p>
<p>With an organic growth of 20% per year, the AGQ Labs group has also acquired several laboratories in order to accelerate entry into new markets or to incorporate new analytical capabilities and technologies</p>
<blockquote><p>From NL42 Consulting “we appreciate the trust AGQ Labs has placed on us and we are eager to reach the key milestones of this innovative project, working closely with the AGQ Labs project team” comments Roberto Castelnovo, CEO at NL42 Consulting.</p></blockquote>
<h3><span style="color: #666699;">For more information on NL42 services read more about <a style="color: #666699;" href="https://www.nl42.com/restart_together/">&#8221; let&#8217;s restart together&#8221;  </a></span></h3>
<p>L'articolo <a href="https://www.nl42.com/agq-labs-moves-its-data-driven-laboratories-strategy-to-the-next-level/">AGQ Labs moves its data driven laboratories strategy to the next level</a> proviene da <a href="https://www.nl42.com">NL42 | Paperless Lab Academy®</a>.</p>
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		<item>
		<title>Are your Data Management Policies supporting the GXP compliance?</title>
		<link>https://www.nl42.com/are-your-data-management-policies-supporting-the-gxp-compliance/</link>
		
		<dc:creator><![CDATA[Roberto Castelnovo]]></dc:creator>
		<pubDate>Thu, 10 Sep 2020 14:01:53 +0000</pubDate>
				<category><![CDATA[Data Integrity]]></category>
		<category><![CDATA[IT Strategy]]></category>
		<category><![CDATA[CSV]]></category>
		<category><![CDATA[GXP compliance]]></category>
		<guid isPermaLink="false">https://www.nl42.com/?p=3569</guid>

					<description><![CDATA[<p>Understanding the criticality of setting Master Data and Policies Your Data lifecycle extends across departments and its governance requires good practices to be followed. Understanding the criticality&#8217;s of setting common Master Data and policies is very important and extended educational efforts should be considered at corporate level. When implementing digital solutions for quality processes, GxP [&#8230;]</p>
<p>L'articolo <a href="https://www.nl42.com/are-your-data-management-policies-supporting-the-gxp-compliance/">Are your Data Management Policies supporting the GXP compliance?</a> proviene da <a href="https://www.nl42.com">NL42 | Paperless Lab Academy®</a>.</p>
]]></description>
										<content:encoded><![CDATA[<h2><span style="color: #666699;">Understanding the criticality of setting Master Data and Policies</span></h2>
<p>Your <strong>Data lifecycle</strong> extends across departments and its <strong>governance</strong> requires good practices to be followed. Understanding the criticality&#8217;s of setting common <strong>Master Data</strong> and <strong>policies</strong> is very important and extended educational efforts should be considered at corporate level.</p>
<p>When implementing digital solutions for <strong>quality processes, GxP activities,</strong> the data management policies should apply to any computer software’s involved, all along the data lifecycle, data workflows and related processes, with particular attention to system integrations.</p>
<p>Setting adequate policies for <strong>Validation</strong> and <strong>Data Integrity</strong> is crucial to ensure the required corporate quality levels in managing your data and controlling the right functioning of those computerized systems throughout their life.</p>
<p>This article is providing a summary of the key concepts to be considered for validation management and the ones for ensuring proper data integrity policies using computerized system.</p>
<h2><span style="color: #666699;">Build Comprehensive Validation Policies for the computerized systems involved in your data lifecycle.</span></h2>
<p>The validation policy should be applicable to any computerized system that is deemed to have an impact on GxP activities. Examples of such systems include, but are not limited to, automated manufacturing or laboratory equipment, process control systems, MES, LIMS, regulatory compliance, and document management systems.</p>
<p>The validation cycle should establish documented evidences and provides a high degree of assurance that the systems will operate on day one and will continue to operate along updates and upgrades, amongst all users’ levels, in a reliable and reproducible manner, according to the documented requirements and within a controlled environment.</p>
<h3><span style="color: #666699;">Key concepts to be applied for computerized system validation management</span></h3>
<ol>
<li><span style="color: #666699;">Design and manage the system lifecycle under Quality requirements. </span></li>
</ol>
<p>The compliant state of the systems must be maintained until the systems are decommissioned. From the first moment, i.e. concept of the system, through implementation and routine operation till complete retirement of the computerized system, appropriate documented procedures must be developed and followed accordingly.</p>
<ol start="2">
<li><span style="color: #666699;">Adapt the validation lifecycle activities based on the outcome of both Risk and Supplier Assessments.</span></li>
</ol>
<p>The validation efforts all along the computer software lifecycle are directly proportional of the outcome of the risk assessment and the supplier assessment.</p>
<p>An audit of the Supplier´s Quality system will provide an excellent baseline to extrapolate the effort required for initial validation and for supervision of the updates, upgrades and good functioning during its entire lifetime.</p>
<p>Additionally, the risk evaluation should consider the system complexity, its maturity level and the functionality required to control the underlying processes, along with the amount of data to be stored, recalled, processed and secured. The architecture of the hardware and the software that comprise the computerized system will also have an impact on the system complexity and must be considered when developing the validation activities. Finally, the configuration of the software application and the software functionalities must also be considered in the validation process and as such during the risk assessment.</p>
<ol start="3">
<li><span style="color: #666699;">Leverage the supplier involvement </span>th<span style="font-size: 16px;">roughout the validation lifecycle activities. The supplier may be able to provide a </span><span style="font-size: 16px;">considerable degree of expertise through the process and help reduce the validation activities. Where documents are supplied, those should be reviewed and accepted for use.</span></li>
</ol>
<h2><span style="color: #666699;">Ensure solid Data Integrity Policies that cover your complete Data Life Cycle</span></h2>
<p><strong> </strong>These policies should describe responsibilities and activities related to the integrity of your data collection, storage, management and archival on the computerized systems. The necessary measures should be defined to satisfy the data integrity requirements, (see ALCOA definition) and guarantee that data collected and managed are complete, consistent and accurate throughout the entire data life cycle.</p>
<h3><span style="color: #666699;">Key concepts to be considered to ensure proper data integrity policies using computerized system </span></h3>
<ol>
<li><span style="color: #666699;">Evaluate the system criticality </span>through a risk assessment to define priorities in reinforcements and liability of the system to be validated</li>
<li><span style="color: #666699;">Assess and address Interfaces</span> during validation to ensure that transfer of data are correct and complete. The interface between the originating system, data acquisition and recording systems should be validated to ensure the accuracy of data. It should always be possible at any time, at any decision level, to easily access the original raw data.</li>
<li><span style="color: #666699;">Incorporate validated checks to ensure the completeness of data acquired</span>, as well as any metadata associated with the data. Ensure that critical data are reviewed by the appropriate user and verified to determine that operations were performed correctly. Any necessary changes to data must be authorized and controlled in accordance with approved procedures.</li>
<li>Configure and enforce <span style="color: #666699;">User access controls </span>so that Input of data and changes to computerized records are made only by authorized personnel</li>
<li>Assigned <span style="color: #666699;">Individual Login IDs</span> and passwords for all and every staff needing to access and utilize the specific electronic system in order to allow proper traceability. Shared users are not allowed for GxP critical activities.</li>
<li>Define standard procedure for new users’ settings and requests for new privileges.</li>
<li><span style="color: #666699;">Configure Audit Trail functionalities </span>properly to capture any activities related to the acquisition, deletion, overwriting and changes to data for audit purposes.</li>
<li><span style="color: #666699;">Ensure solid format storage </span>to ensure that data are not vulnerable to manipulation, loss or change. Storage of data must include the entire original data and metadata, including audit trails, using a secure and validated process. The data should be accessible and readable, and its integrity maintained for all the period of archiving</li>
<li><span style="color: #666699;">Define procedures for Backup and copies.</span>They must have the same appropriate levels of controls so as to prohibit unauthorized access to, changes to and deletion of data or their alteration. <strong>True copies</strong> of dynamic electronic records can be made, with the expectation that the entire content (i.e., all data and metadata) is included and meaning of the original records are preserved.</li>
<li><span style="color: #666699;">Define Procedures that describe the process for the disposal of electronically stored data.</span> These procedures should provide guidance for the assessment of data and allocation of retention periods and describe the manner in which data that is no longer required is disposed of.</li>
</ol>
<p><span style="color: #666699;">From NL42 consulting, we can help you setting the adequate set of policies. We review and audit your situation, provide risk assessment, supplier assessment and recommendations for remediation when needed.</span></p>
<h2><span style="color: #ff9900;">Just contact us for initial evaluation</span></h2>
<p>L'articolo <a href="https://www.nl42.com/are-your-data-management-policies-supporting-the-gxp-compliance/">Are your Data Management Policies supporting the GXP compliance?</a> proviene da <a href="https://www.nl42.com">NL42 | Paperless Lab Academy®</a>.</p>
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		<item>
		<title>6 Factors for a successful Implementation  of a Laboratory Information Management System (LIMS)</title>
		<link>https://www.nl42.com/6-factors-for-a-successful-implementation-of-a-lims/</link>
		
		<dc:creator><![CDATA[Roberto Castelnovo]]></dc:creator>
		<pubDate>Mon, 13 Jul 2020 09:54:45 +0000</pubDate>
				<category><![CDATA[Digital Transformation]]></category>
		<category><![CDATA[IT Strategy]]></category>
		<category><![CDATA[Lab Data Management]]></category>
		<category><![CDATA[change management]]></category>
		<category><![CDATA[change process]]></category>
		<category><![CDATA[laboratory informatics]]></category>
		<category><![CDATA[LIMS]]></category>
		<category><![CDATA[paperless processes]]></category>
		<category><![CDATA[project management]]></category>
		<category><![CDATA[smartlaboratory]]></category>
		<guid isPermaLink="false">https://www.nl42.com/?p=3548</guid>

					<description><![CDATA[<p>Have you implemented a Laboratory Information Management Solution without really benefiting from all its capabilities? Unfortunately, it is frequent to discover that the Laboratory Information Management Solution implemented in a site is not providing all the resources and insights that the laboratory and its stakeholders would benefit from. Too many factors influence the success of [&#8230;]</p>
<p>L'articolo <a href="https://www.nl42.com/6-factors-for-a-successful-implementation-of-a-lims/">6 Factors for a successful Implementation  of a Laboratory Information Management System (LIMS)</a> proviene da <a href="https://www.nl42.com">NL42 | Paperless Lab Academy®</a>.</p>
]]></description>
										<content:encoded><![CDATA[<h2><span style="color: #666699;">Have you implemented a Laboratory Information Management Solution without really benefiting from all its capabilities?</span></h2>
<p>Unfortunately, it is frequent to discover that the Laboratory Information Management Solution implemented in a site is not providing all the resources and insights that the laboratory and its stakeholders would benefit from.</p>
<p>Too many factors influence the success of a system implementation, irrespective of the LIMS providers, the type of lab or the size. Too often the project gets delayed. Too often phase 2 never takes off. Final users end up using very limited parts of the system, missing the full capabilities.</p>
<h2><span style="color: #666699;">6 Factors for a successful Implementation of a Laboratory Information Management System</span></h2>
<h3><span style="color: #666699;">1.     Use the right approach during the purchasing phase</span></h3>
<p>The selection process of a software system is not just about the product but also about the company that you´re about to embrace in a long-term relationship. There are critical issues to examine prior to purchase and the vendor information should enable a quality assessment of their processes and their software’s design.</p>
<p>One essential starting point is the proposed Project Plan and its granularity, including the names, roles and CVs of the people involved in your project. The quality of this first deliverable will already tell you a lot.</p>
<p>Your company has also a critical responsibility in the initial phases: clear company, business and technical requirements will avoid misunderstanding to ensure that:</p>
<ul>
<li>All necessary items to complete the project are included in the offer. If something is missing while the requirements are perfectly clear should be provided at no extra cost</li>
<li>Implementation phases are not meant to discover hidden costs throughout the project. Everything should be clarified upfront (i.e. additional required licences, additional services, maintenance costs)</li>
<li>Instrument connection is always very much underestimated. How many instruments should be connected, when and the related costs of any type (software, services, third-party items, etc.)</li>
<li>List of available documentation from the provider (i.e. IQ, OQ, release notes, technical documents, project management documents, quality manuals, etc.)</li>
<li>Future updates and upgrades should be clear since the beginning: how often? is the vendor’s support required? is additional validation required?</li>
<li>The preparation of a 5 years investment projection, including software, services, validation, maintenance at minimum</li>
</ul>
<h3><span style="color: #666699;">2. Getting the team in place </span></h3>
<p><a href="https://www.nl42.com/going-paperless-2-get-prepared-for-successful-digital-transformation-project/">The human Factor is key for a successful digital transformation project</a>. Ideally your project manager, enabled and supported by his/her project sponsor, should be entitled to gather knowledgeable and committed persons into the project. In the real world this is often not the case. Those people used to be completely overbooked and involved in other projects already.</p>
<p>Anyhow, do not overlook the change management aspect of the project and plan far in advance how you want to approach it. We warmly recommend involving the team members far in advance in the project in order to get their buy-in and hopefully convert them into evangelists</p>
<h3><span style="color: #666699;">3. Breaking Down the Elephant</span></h3>
<p>Pure project management statement here. Clear milestones and achievable goals in short periods of time will drive you to success.</p>
<p>Along with a good communication plan to your team and stakeholders, you´ll be able to show the achievement, raise concerns, drive changes when necessary, and celebrate.</p>
<h3><span style="color: #666699;">4. Managing Change Requests</span></h3>
<p>Any required changes will affect the project plan. There are no small changes outside the scope already agreed that won’t affect the time and cost of the project.</p>
<p>Changes affect also provider’s agenda that might not be able anymore to stick to the initial project plan because their resources are already assigned to other projects. You might end up queueing in their agenda and end up in an infinite loop of agenda clash between yours and theirs</p>
<h3><span style="color: #666699;">5. Understanding your provider</span></h3>
<p>You are the customer and as such the provider cares about you and the success of the implementation. A customer having a bad experience in implementing their system is worse than losing the deal from the reputation point of view. Your company’s name cannot be used as a reference. The risk is that the provider considers the time and cost required to recover your satisfaction is far too high to classify it as a sustainable project. The implementation project should always be a win-win collaboration.</p>
<h3><span style="color: #666699;">6. Planning for the Validation far in advance</span></h3>
<p>Correct documentation and execution of the Computer system validation is a key asset to demonstrate auditors the level and maturity of your quality management system. Remember that the concept of computer system validation is typically linked to only few markets. This is absolutely not the case. All customers need to check that the delivered system is fitting with the expectations. This takes place by testing the delivered functionalities, irrespective the market you operate</p>
<p>Most of the documentation required for the correct execution of the validation should be available when the implementation starts. Believe it or not, this will already influence your implementation success because all the information collected in these documents will form the backbone of your project, the key reference for all parties involved. Below you find a list (not complete) of documents that you should take into account during the project preparation and execution</p>
<ul>
<li>Project preparation
<ul>
<li>High-level project plan and project team information</li>
<li>Statement of Work</li>
<li>Software Licence Agreement or Subscription Agreement</li>
<li>Maintenance Services description</li>
<li>Information about the Quality System of the provider</li>
<li>Technical documents related to system integration and instrument connection</li>
<li>Business, technical, corporate, IT and regulatory requirements at minimum</li>
</ul>
</li>
<li>Project implementation
<ul>
<li>Detailed project plan</li>
<li>IQ, OQ and PQ</li>
<li>Validation Master Plan</li>
<li>Communication Plan</li>
<li>Change management Plan</li>
<li>Issue management</li>
</ul>
</li>
</ul>
<p>The upgrade or replacement of a legacy will become a critical aspect of the laboratory data management in the near future. A lot of systems that have been implemented even more than 10 years ago are still operating. They are causing huge difficulties from the technical and maintenance points of view or they are simply not offering anymore the responses to the business needs. The upgrade or replacement projects might be overwhelming.</p>
<p>We can help here!  For instance Process Review is a great opportunity to speak out and highlight the pains and the expectations during coordinated workshops. Requirements and priorities are then popping up easily for better decision making and driving of your project milestones.</p>
<h3><strong><span style="color: #800080;"><span style="color: #666699;">Should you have any questions do not hesitate to contact me: </span><a href="mailto:roberto.castelnovo@Nl42.com"><span style="color: #666699;">roberto.castelnovo@Nl42.com </span></a></span></strong></h3>
<p>L'articolo <a href="https://www.nl42.com/6-factors-for-a-successful-implementation-of-a-lims/">6 Factors for a successful Implementation  of a Laboratory Information Management System (LIMS)</a> proviene da <a href="https://www.nl42.com">NL42 | Paperless Lab Academy®</a>.</p>
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		<title>How to be sure that your Data Integrity project has fully covered your eData LifeCycle?</title>
		<link>https://www.nl42.com/how-to-secure-data-integrity-along-your-edata-life-cycle/</link>
		
		<dc:creator><![CDATA[Roberto Castelnovo]]></dc:creator>
		<pubDate>Sun, 21 Jun 2020 16:20:19 +0000</pubDate>
				<category><![CDATA[Data Integrity]]></category>
		<category><![CDATA[Digital Transformation]]></category>
		<category><![CDATA[IT Strategy]]></category>
		<category><![CDATA[Lab Data Management]]></category>
		<category><![CDATA[data integration]]></category>
		<category><![CDATA[data integrity]]></category>
		<category><![CDATA[laboratory informatics]]></category>
		<category><![CDATA[paperless data management]]></category>
		<category><![CDATA[process improvement]]></category>
		<guid isPermaLink="false">https://www.nl42.com/?p=3527</guid>

					<description><![CDATA[<p>The integrity of your Data along their lifecycle This is not another data integrity article, yet this is about demonstrating to auditors that you do have it all right and under control. So we&#8217;d like to highlight the importance of assessing the complete life cycle of your data and managing it for complete compliance to [&#8230;]</p>
<p>L'articolo <a href="https://www.nl42.com/how-to-secure-data-integrity-along-your-edata-life-cycle/">How to be sure that your Data Integrity project has fully covered your eData LifeCycle?</a> proviene da <a href="https://www.nl42.com">NL42 | Paperless Lab Academy®</a>.</p>
]]></description>
										<content:encoded><![CDATA[<h2><span style="color: #666699;">The integrity of your Data along their lifecycle</span></h2>
<p>This is not another data integrity article, yet this is about demonstrating to auditors that you do have it all right and under control. So we&#8217;d like to highlight the importance of assessing the complete life cycle of your data and managing it for complete compliance to data integrity requirements.</p>
<p>We’ve all attended the thousand trainings, webinars and presentation about Data Integrity recommendations and guidelines. We know by heart the ALCOA definition and read several scary 483 letters.</p>
<p>You probably have also been involved in a specific DI project in your company or simply been asked to attend a series of internal training courses to increase self-awareness about the impacts of your actions. Corporate policies and messaging reinforced with nice posters have also probably popped up and decorated nicely the corridors and the cafeteria.</p>
<p>Beside the human factor being approached by reinforcing corporate ethical rules, the integrity of your data is a matter of managing adequately the company data lifecycle and in its multiple data workflows.</p>
<p>We, at NL42 ,are known at the Paperless Lab Academy for reinforcing the concept that no digital transformation project goes without a clear understanding of your data life cycle which we organise in 4 main steps when speaking about electronic data:<strong> eData</strong>, we will focus on the initial raw data capturing at <strong>eConnect</strong>, correct and compliant handling at <strong>eManage</strong>, easy access to data insight for sound decision making at <strong>eDecide</strong> .</p>
<p><img fetchpriority="high" decoding="async" class="aligncenter wp-image-3529" src="https://www.nl42.com/wp-content/uploads/2020/06/eDataLifeCycle-1024x715.png" alt="Data integrity in your eData Life Cycle" width="617" height="431" srcset="https://www.nl42.com/wp-content/uploads/2020/06/eDataLifeCycle-1024x715.png 1024w, https://www.nl42.com/wp-content/uploads/2020/06/eDataLifeCycle-300x209.png 300w, https://www.nl42.com/wp-content/uploads/2020/06/eDataLifeCycle-768x536.png 768w, https://www.nl42.com/wp-content/uploads/2020/06/eDataLifeCycle-1140x796.png 1140w, https://www.nl42.com/wp-content/uploads/2020/06/eDataLifeCycle-1000x698.png 1000w, https://www.nl42.com/wp-content/uploads/2020/06/eDataLifeCycle-645x450.png 645w, https://www.nl42.com/wp-content/uploads/2020/06/eDataLifeCycle-560x391.png 560w, https://www.nl42.com/wp-content/uploads/2020/06/eDataLifeCycle-750x524.png 750w, https://www.nl42.com/wp-content/uploads/2020/06/eDataLifeCycle-400x279.png 400w, https://www.nl42.com/wp-content/uploads/2020/06/eDataLifeCycle.png 1441w" sizes="(max-width: 617px) 100vw, 617px" /></p>
<h2><span style="color: #666699;">Two major concerns the auditors will focus on</span></h2>
<p>When investigating possible Data Integrity breaches, auditors are in the end, just using common sense and applying an implacable logic on “HOW” your data are managed. They will tend more and more to prefer seeing digital solutions implemented, with CFR21/11 capabilities enabled, correct users´ right access definitions and more. Even if all possible human interactions prone to transcription errors are removed, there are still two major concerns the auditors will focus on.</p>
<h3><span style="color: #666699;">1)    Accessing the original raw data and its metadata</span></h3>
<p>The eConnect step is becoming of crucial importance as the attention of the auditors is moving to laboratory instrumentation and capabilities to provide electronic format of their data ouput. Raw data and corresponding metadata should be accessible in order to verify easily non only the final result outcome but to review the whole data processing itself too.</p>
<p>Additionally, to the capability to review the data processing, all related information about quality control records, exceptions and re-evaluation should be perfectly accessible anytime.</p>
<p>Curiously for the past 10 years, even though the laboratory information management systems have considerably improved their interfacing capabilities with the laboratory instruments, the instrument integration tend to fall always in a phase 2 implementation and most of the time not being implemented at all.</p>
<h3><span style="color: #666699;">2)    Assessing the Vendor, Documenting and Validating the computerised systems</span></h3>
<p>Assessing the vendor´s product development quality system, documenting from the very first moment of the project planning to ease the validation steps is again a strong recommendation from our side.</p>
<p>Unfortunately, this had to be reinforced again recently by the EMA. In April 2020, the EMA has released a “Notice to sponsors on validation and qualification of computerised systems used in clinical trials” that could easily be extended to any scientific data management workflow still not matured enough regarding data integrity management.</p>
<p>The integrity of your paperless processes is built on the foundation of thorough understanding of your data lifecycle and precise documentation for qualifying the functionalities and validate the reliability and robustness of your computerised system in managing your data. Failure to document and therefore demonstrate the validated state of a computerised system is likely to pose a risk<strong>.</strong></p>
<h2><span style="color: #666699;">Join our project <span style="color: #993366;"><a style="color: #993366;" href="https://www.nl42.com/restart_together/">&#8220;Let´s Restart Together&#8221;</a> </span>, we can help you! </span></h2>
<h2><span style="color: #666699;">We´d like to help you in making sure your investment in time and money are fully compliant and protecting you from any potential risk.</span></h2>
<h2><a href="https://www.nl42.com/contact-us/"><span style="color: #666699;"><span style="color: #ff6600;">Contact us </span></span></a></h2>
<p>&nbsp;</p>
<p>L'articolo <a href="https://www.nl42.com/how-to-secure-data-integrity-along-your-edata-life-cycle/">How to be sure that your Data Integrity project has fully covered your eData LifeCycle?</a> proviene da <a href="https://www.nl42.com">NL42 | Paperless Lab Academy®</a>.</p>
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		<title>The Laboratory of the Industry 4.0</title>
		<link>https://www.nl42.com/laboratory-industry-40/</link>
		
		<dc:creator><![CDATA[Roberto Castelnovo]]></dc:creator>
		<pubDate>Mon, 03 Dec 2018 09:18:14 +0000</pubDate>
				<category><![CDATA[IT Strategy]]></category>
		<category><![CDATA[Lab Data Management]]></category>
		<category><![CDATA[#industry4.0]]></category>
		<category><![CDATA[laboratory 4.0]]></category>
		<category><![CDATA[laboratory informatics]]></category>
		<category><![CDATA[paperless lab academy]]></category>
		<category><![CDATA[paperless processes]]></category>
		<category><![CDATA[process improvement]]></category>
		<category><![CDATA[smartlab]]></category>
		<category><![CDATA[smartlaboratory]]></category>
		<guid isPermaLink="false">https://www.nl42.com/?p=3071</guid>

					<description><![CDATA[<p>Organizing an event like the Paperless Lab Academy requires strong project management skills, execution at its best and a lot of energy. However, the very best part of it is the outstanding opportunities to engage with so many active members of the lab informatics industry and its final users. While discussing the content of their [&#8230;]</p>
<p>L'articolo <a href="https://www.nl42.com/laboratory-industry-40/">The Laboratory of the Industry 4.0</a> proviene da <a href="https://www.nl42.com">NL42 | Paperless Lab Academy®</a>.</p>
]]></description>
										<content:encoded><![CDATA[<p>Organizing an event like the <a href="http://www.paperlesslabacademy.com" target="_blank" rel="noopener noreferrer">Paperless Lab Academy</a> requires strong project management skills, execution at its best and a lot of energy. However, the very best part of it is the outstanding opportunities to engage with so many active members of the lab informatics industry and its final users.</p>
<p>While discussing the content of their presentation or workshop for the #PLA2019 agenda, we definitely enjoy discovering people analysis on their today pains and their vision of the lab of the future.</p>
<p>Fact is that I’d like to share some of my thoughts out of so many conversations. When speaking to production and management, it is common to detect a lack of visibility of how the laboratory operates. Yet the expectations on quick and trustable results are omnipresent. It is also easy to generate attention when speaking about the Industry 4.0, automation, data exchange, Internet of things, cloud and more.</p>
<p>Who says that this is not also available for the laboratories too? Let´s do a small comparative exercise of how the industry and the laboratories have evolved through the technical revolutions.</p>
<h2><strong>The first industrial revolution began through the use of steam power and mechanization of production</strong></h2>
<p>The first industrial revolution began in Britain in the late 18th century, with the mechanization of the textile industry. Tasks previously done laboriously by hand in hundreds of weavers&#8217; cottages were brought together in a single cotton mill, and the factory was born.</p>
<p>Even though the evidence places Pythagoras of Samos´s home laboratory as the earliest laboratory. The pictures of Antoine Lavoisier laboratory are a good representation of the chemical laboratory used by his contemporaries in the 18<sup>th</sup> century. Additionally, the researcher started to work in teams in the 19th century along with exhaustive laboratory notebooks, the first definitions of standard operation procedures and stimulating scientific meetings sharing results and theories.</p>
<h2><strong>The second industrial revolution</strong> <strong>mastered the moving assembly line</strong></h2>
<p>The second industrial revolution came in the early 20th century when Henry Ford mastered the moving assembly line, and the age of mass production was born.</p>
<p>In the 20<sup>th</sup> century, the laboratory equipment was composed of highly precise glassware’s (Erlenmeyer flasks, graduated cylinders, volumetric flasks), controlled reagents, autoclave, personal protective equipment, measuring devices, extractor hoods, cold rooms, incubators, micropipettes and a long list of specialized instruments and devices. The mass production effect in the manufacturing lines can easily be compared to the scientific instruments. Those instruments are more complex in their role of performing an experiment, taking measurements and gathering data. They had the firmware communicating with a specific software for setup, configuration, raw data collection, and first results outcomes. The analysis of multiples samples in a row, plates of 96 and 384 wells and arrays have generated an incredible amount of data and permitted, for instance, the complete sequence of the human genome by 2003. The project <em>per se</em> started in 1990 and speed exponentially from 2000 with the launch of new analytical technologies, software and database capabilities, the era of the bioinformatics was born. Which brings us to the 3<sup>rd</sup> revolution.</p>
<h2><strong>The third industrial revolution made the manufacturing industry going digital.</strong></h2>
<p>Curiously, while the analytical instruments are generating an enormous amount of digital data and the internet of things enables the collection of data from multiple sources, the paper is still the main support of the laboratory processes. The measuring devices like balances and pipettes are generating information collected automatically and unequivocally. As an example, the IoT provides also very useful information controlling the sample storage conditions.  Anyhow, we might say that most of the laboratories are still staying here, in the waves of the third industrial revolution. Too many chromatograms are still printed and attached to a dossier. There is a long way to go for the majority of the labs in moving from paper-based processes and in undergoing their own digital transformation process. However, the technologies, concepts, and objectives of the fourth industrial revolution are already here to serve the laboratory.</p>
<h2><strong>Four principles of the fourth industrial revolution </strong></h2>
<p><img decoding="async" class="wp-image-3073 alignleft" src="https://www.nl42.com/wp-content/uploads/2018/12/index-1-300x116.png" alt="" width="385" height="149" srcset="https://www.nl42.com/wp-content/uploads/2018/12/index-1-300x116.png 300w, https://www.nl42.com/wp-content/uploads/2018/12/index-1.png 361w" sizes="(max-width: 385px) 100vw, 385px" /></p>
<p>&nbsp;</p>
<p>The fourth revolution gets the machines, devices, sensors, and people to connect and communicate within an Internet of things scenario and they cooperatively drive production. <strong>The principles: interconnection, information transparency, technical assistance, decentralized decisions.</strong>  That is the vision for the Fourth Industrial Revolution.</p>
<p>Those principles are the ones making the laboratory 4.0 of today.</p>
<p>Technicians and analysts have the ability to connect and communicate with their analytical instruments, devices, and sensors. Above all, the automatic capture of the data is the essence of the so pursued data integrity compliance. Interconnectivity allows such transparency to managers that enables them to collect immense amounts of data and information from all points along the data lifecycle. To assist the data analysis, the systems support managers by aggregating and visualizing information comprehensively for making informed decisions.</p>
<p>In a production line, we would easily see the fourth revolution facilitating flexible, individualized and resource-friendly mass production.  In a laboratory, the managers would benefit from systems making decisions on their own and performing their tasks as autonomously as possible, having them focusing only in the case of exceptions, interferences, or conflicting goals.</p>
<p><strong>If ever a laboratory is able to focus human attention in what I</strong><strong> like to call &#8220;review by exception&#8221; only, the Laboratory 4.0 is born.</strong></p>
<p>&nbsp;</p>
<blockquote><p><span style="color: #666699;">At the #PLA2019, we´ll be discussing much more about the today and the future laboratory. How to turn the lab into a data-driven knowledge center will be central of the 7th edition.</span></p>
<p><span style="color: #666699;">Do not miss it! Registrations are free for visitors coming from companies that own a laboratory</span></p>
<p><span style="color: #666699;">Check out for more here:</span><a href="http://www.paperlesslabacademy.com" target="_blank" rel="noopener noreferrer"><span style="color: #666699;"> www.paperlesslabacademy.com </span></a></p></blockquote>
<p>&nbsp;</p>
<p>&nbsp;</p>
<p>L'articolo <a href="https://www.nl42.com/laboratory-industry-40/">The Laboratory of the Industry 4.0</a> proviene da <a href="https://www.nl42.com">NL42 | Paperless Lab Academy®</a>.</p>
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		<title>Discover how to empower your eData Life Cycle</title>
		<link>https://www.nl42.com/empower-your-edata-life-cycle/</link>
		
		<dc:creator><![CDATA[Isabel Munoz]]></dc:creator>
		<pubDate>Wed, 31 Jan 2018 17:09:25 +0000</pubDate>
				<category><![CDATA[Coming Events]]></category>
		<category><![CDATA[IT Strategy]]></category>
		<category><![CDATA[Paperless Lab]]></category>
		<category><![CDATA[lab informatics event]]></category>
		<category><![CDATA[PLA2018]]></category>
		<guid isPermaLink="false">https://www.nl42.com/?p=2619</guid>

					<description><![CDATA[<p>Paperless Lab Academy 2018 central theme: &#8221; Empowering your eData Life Cycle: eConnect, eManage, eDecide, eArchive&#8221; The 6th edition of the Paperless Lab Academy will be held in Italy at the Lake Maggiore, march 20/21 2018 NL42 is glad to confirm the full support of more than 20 sponsors, from key leaders of the lab [&#8230;]</p>
<p>L'articolo <a href="https://www.nl42.com/empower-your-edata-life-cycle/">Discover how to empower your eData Life Cycle</a> proviene da <a href="https://www.nl42.com">NL42 | Paperless Lab Academy®</a>.</p>
]]></description>
										<content:encoded><![CDATA[<h2><span style="color: #666699;">Paperless Lab Academy 2018 central theme: &#8221; Empowering your eData Life Cycle: eConnect, eManage, eDecide, eArchive&#8221;</span></h2>
<p>The 6th edition of the Paperless Lab Academy will be held in Italy at the Lake Maggiore, march 20/21 2018</p>
<p><img decoding="async" class="size-medium wp-image-2671 alignleft" src="https://www.nl42.com/wp-content/uploads/2018/01/OG_LinkedIn-768x402-300x157.jpg" alt="" width="300" height="157" srcset="https://www.nl42.com/wp-content/uploads/2018/01/OG_LinkedIn-768x402-300x157.jpg 300w, https://www.nl42.com/wp-content/uploads/2018/01/OG_LinkedIn-768x402.jpg 768w, https://www.nl42.com/wp-content/uploads/2018/01/OG_LinkedIn-768x402-645x338.jpg 645w, https://www.nl42.com/wp-content/uploads/2018/01/OG_LinkedIn-768x402-560x293.jpg 560w, https://www.nl42.com/wp-content/uploads/2018/01/OG_LinkedIn-768x402-750x393.jpg 750w, https://www.nl42.com/wp-content/uploads/2018/01/OG_LinkedIn-768x402-400x209.jpg 400w" sizes="(max-width: 300px) 100vw, 300px" />NL42 is glad to confirm the full support of more than 20 sponsors, from key leaders of the lab informatics market to brand new comer with attractive and innovative solutions ready to challenge with newest technologies.</p>
<p>The industry has generated interesting news in the last months. To mention few out of multiple collaborations between partners we should highlight the acquisition of Core Informatics from Thermo Fisher  Scientific and the acquisition of LabAnswer from Accenture.We had the pleasure to run an interview with the key players of this last one. <strong><a href="http://www.paperlesslabacademy.com/2017/06/22/nl42-interviews-accenture-labanswer/" target="_blank" rel="noopener noreferrer">read here: NL42 interviews Accenture and Labanswer on the recent announcement.</a> </strong></p>
<h2><span style="color: #666699;">Why should you consider coming at the PLA2018?</span></h2>
<ul>
<li>+20 sponsors, lab informatics providers presenting their solutions to be on the know of the latest</li>
<li>Workshop interactives sessions to benefit multiple live demonstrations in 2 days</li>
<li>Plenary sessions of non commercial content to learn from user experiences, case studies, thought leaders vision of the lab of the future</li>
<li>Networking sessions to interact with peers, colleagues and partners</li>
<li><strong><a href="http://www.paperlesslabacademy.com/registration/" target="_blank" rel="noopener noreferrer">Free Access</a> </strong>( after registration) to companies that own a laboratory</li>
</ul>
<h2><span style="color: #666699;">How to make the most of the PLA2018?</span></h2>
<ul>
<li>Check the <strong><a href="http://www.paperlesslabacademy.com/workshops/" target="_blank" rel="noopener noreferrer">workshops list</a></strong> and draft your agenda</li>
<li>Consider coming with a colleague to split in the parallel sessions</li>
<li>Identify your primary business needs of your lab and seek for the <strong><a href="http://www.paperlesslabacademy.com/agenda-2018/" target="_blank" rel="noopener noreferrer">presentations and speakers</a></strong> that will bring you significant insight</li>
<li>Connect with your peers through the event app. and meet eachother</li>
<li>Need some support? just <a href="https://www.nl42.com/who-we-are/" target="_blank" rel="noopener noreferrer"><strong>reach us</strong> </a>before, during and after the event</li>
</ul>
<h2><span style="color: #666699;">Who are visiting us every year?</span></h2>
<table width="100%" class="table " style="">
<tbody>
<tr>
<td>People visiting us every year rank from:</td>
<td>
<ul>
<li>Laboratory Directors and Managers</li>
<li>Operational Excellence</li>
<li>IT Business Partners</li>
<li>QC and QA Management</li>
<li>Research departments</li>
<li>Manufacturing</li>
</ul>
</td>
</tr>
<tr>
<td>Industries that benefit from the PLA include:</td>
<td>
<ul>
<li>Pharmaceutical</li>
<li>Chemical</li>
<li>Lab Services</li>
<li>Biotech</li>
<li>Food &amp; Beverage</li>
<li>Consumer Goods</li>
<li>Cosmetic</li>
<li>Oil &amp; Gas</li>
</ul>
</td>
</tr>
</tbody>
</table>
<p>&nbsp;</p>
<p>L'articolo <a href="https://www.nl42.com/empower-your-edata-life-cycle/">Discover how to empower your eData Life Cycle</a> proviene da <a href="https://www.nl42.com">NL42 | Paperless Lab Academy®</a>.</p>
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		<title>NL42 Consulting takes on Paperless Lab Academy management</title>
		<link>https://www.nl42.com/pressrelease-nl42-takes-on-paperless-lab-academy/</link>
		
		<dc:creator><![CDATA[Isabel Munoz]]></dc:creator>
		<pubDate>Fri, 07 Apr 2017 14:02:14 +0000</pubDate>
				<category><![CDATA[IT Strategy]]></category>
		<category><![CDATA[Paperless Lab]]></category>
		<category><![CDATA[#dataintegrity]]></category>
		<category><![CDATA[#industry4.0]]></category>
		<category><![CDATA[#IoLT]]></category>
		<category><![CDATA[#PLA2017]]></category>
		<category><![CDATA[#pressrelease]]></category>
		<category><![CDATA[paperless lab academy]]></category>
		<guid isPermaLink="false">http://blog.nl42.com/?p=1949</guid>

					<description><![CDATA[<p>&#8211; PRESS RELEASE &#8211; Paperless Lab Academy (PLA), Europe’s leading laboratory automation event, brings partners and attendees together in an environment designed to promote mutual interaction and exchange of views during plenary sessions and topic-focused workshops. The fifth edition of the two-day event, organized by Industrial Lab Automation and NL42 Consulting took place from 4 [&#8230;]</p>
<p>L'articolo <a href="https://www.nl42.com/pressrelease-nl42-takes-on-paperless-lab-academy/">NL42 Consulting takes on Paperless Lab Academy management</a> proviene da <a href="https://www.nl42.com">NL42 | Paperless Lab Academy®</a>.</p>
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										<content:encoded><![CDATA[<p style="text-align: center;"><strong><span style="color: #666699;">&#8211; PRESS RELEASE &#8211;</span></strong></p>
<p style="text-align: justify;">Paperless Lab Academy (PLA), Europe’s leading laboratory automation event, brings partners and attendees together in an environment designed to promote mutual interaction and exchange of views during plenary sessions and topic-focused workshops.</p>
<p style="text-align: justify;">The fifth edition of the two-day event, organized by Industrial Lab Automation and NL42 Consulting took place from 4 to 5 April 2017 in Barcelona (Spain) under the theme of <em>2020 Roadmap for digital convergence</em>. The aim of this edition was finding effective ways to transform scientific information into actionable insight.</p>
<blockquote><p><em>The founder of the event, <strong>Peter Boogaard,</strong> CEO of Industrial Lab Automation, explained: ‘Over the past four years, the PLA has been raising awareness of “what works and what doesn’t”. At PLA2017, we’ll be investigating a roadmap for the next decade, and how the convergence of paper and digital is bringing a new dimension to laboratory informatics. The extensive use of data analytics and applying lessons learnt from other industries, such as adopting an Industry 4.0 mind-set, will accelerate and make easer the badly needed integration of scientific equipment with enterprise software, to ensure a cost effective and high quality contribution from the laboratory to the enterprise as a whole.’</em></p></blockquote>
<h3><strong>One of the aims of the new owners of the event, the founders of NL42 Consulting Isabel Muñoz-Willery and Roberto Castelnovo is preserving the unique concept of this annual conference.</strong></h3>
<blockquote><p><em>Isabel said: ‘Under the new management, Peter will continue to play an important role as a member of the <strong>scientific committee.</strong>’ Roberto added: ‘We believe in the successful formula of the PLA which is based on three pillars: content-rich, non-commercial sessions; a showcase of informatics tools and methodologies available today, through interactive workshops hosted by leading suppliers; and free access to all industry delegates.’</em></p></blockquote>
<p>The PLA takes place annually and is aimed at directors and managers of research and development, IT and quality departments in pharmaceutical, cosmetic, biotechnological, petro-chemical and chemical markets.</p>
<p>The event is focused on building the ideal learning platform for all organizations involved in running laboratories, and in consolidating, integrating or simplifying the data they generate.</p>
<p>The 2017 edition was a success both for attendees and sponsors.</p>
<p><strong><span style="color: #333399;">The 3 keynotes included the following topics:</span></strong></p>
<p><strong>&#8220;Transforming Lab Data into Real-Time Actionable Intelligence&#8221;</strong> by <strong>Northwest Analytics’ Chief Technical Officer Louis Halvorsen</strong></p>
<p><strong>&#8220;Exploring the Digital Potential for the Laboratory of the Future&#8221; by Gartner’s Research Vice President Analyst Michael Shanler </strong></p>
<p><strong>&#8220;IoLT and information governance: Understanding and attacking the business, technical and legal issues&#8221; by Sofia van der Meulen from Axon Lawyers. </strong></p>
<p><strong><span style="color: #333399;">20 workshops</span> </strong>were held during the event showcasing different industry lab informatics solutions. Some of the topics discussed during the sessions were: <strong>data integrity</strong>, <strong>data integration &amp; instrument connections, flawless data interfaces</strong>, efficiency drivers of quality control laboratories, <strong>ELN</strong> (Electronic Lab Notebooks), <strong>LIMS</strong>, and data strategy, <strong>data governance</strong>, version control, open source software for research data on academia.  Last but not least, the key major concept , already introduced  at the PLA2016 edition, the <strong>Internet Lab of Things</strong> ( <strong>IoLT</strong>) has been strongly developed by Gartner, Astrix and Cubuslab together with the <strong>Industrial Internet of Things</strong> ( <strong>IIoT</strong>) confirming there are both two converging ecosystems.</p>
<p>More detailed information on the program deployed and post-event articles available at <a href="http://www.paperlesslabacademy.com/">www.paperlesslabacademy.com</a></p>
<p>As of today, several post articles are being published by our media partners and will be added here:</p>
<p class="node__title node-title">From our Premium Media Partner, Scientific Commuting World:  first in series <a href="https://www.scientific-computing.com/news/analysis-opinion/predicting-future-laboratory" target="_blank" rel="noopener noreferrer">&#8220;Predicting the future of the laboratory&#8221;</a></p>
<p><em>Madrid, Spain, e Moordrecht, The Netherlands, 07/02/2017</em></p>
<p>L'articolo <a href="https://www.nl42.com/pressrelease-nl42-takes-on-paperless-lab-academy/">NL42 Consulting takes on Paperless Lab Academy management</a> proviene da <a href="https://www.nl42.com">NL42 | Paperless Lab Academy®</a>.</p>
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		<link>https://www.nl42.com/first-phases-of-a-lims-project/</link>
		
		<dc:creator><![CDATA[Roberto Castelnovo]]></dc:creator>
		<pubDate>Fri, 08 Nov 2013 14:56:03 +0000</pubDate>
				<category><![CDATA[IT Strategy]]></category>
		<category><![CDATA[Lab Data Management]]></category>
		<category><![CDATA[Project Management]]></category>
		<category><![CDATA[data management]]></category>
		<category><![CDATA[laboratory solutions]]></category>
		<category><![CDATA[LIMS]]></category>
		<category><![CDATA[process improvement]]></category>
		<category><![CDATA[project management]]></category>
		<category><![CDATA[user requirements]]></category>
		<category><![CDATA[USR]]></category>
		<guid isPermaLink="false">http://blog.nl42.com/?p=470</guid>

					<description><![CDATA[<p>Laboratory data management is a responsibility of great impact across the company It implies not only the management of the workflow in the laboratory itself. Data collection begins at the moment of samples reception, follows with the decision related to the analysis to be executed (analyst, Standard Operating Procedures, customer priorities&#8230;) and ends with the [&#8230;]</p>
<p>L'articolo <a href="https://www.nl42.com/first-phases-of-a-lims-project/"></a> proviene da <a href="https://www.nl42.com">NL42 | Paperless Lab Academy®</a>.</p>
]]></description>
										<content:encoded><![CDATA[<h2><span style="color: #666699;"><strong>Laboratory data management is a responsibility of great impact across the company</strong> </span></h2>
<p><span style="color: #000000;">It implies not only the management of the workflow in the laboratory itself. Data collection begins at the moment of samples reception, follows with the decision related to the analysis to be executed (analyst, Standard Operating Procedures, customer priorities&#8230;) and ends with the delivery of the final report and invoicing.</span></p>
<p style="text-align: justify;"><span style="color: #000000;">For computer experts it should be easy to design such informatics solutions. If it were not that each stage requires various considerations related to the market in which the laboratory operates, like <strong>traceability, chain of custody, compliance to standards quality</strong> and elaboration of relevant <strong>certificates</strong>. Some of these considerations require enforcement of certain protocols and collection of data in parallel with the analysis. It should still be relatively easy. Yet <strong>each laboratory designs its own workflow,</strong> sets its own <strong>quality assurance/ quality control procedures, </strong>develops its <strong>personnel training program,</strong> decides its <strong>standard calibration</strong> and participation to <strong>inter-laboratory exercises for standardization,</strong> and finally implements a policy to store samples just for few months or several years according to the market legislation. Just to mention few customised aspects and avoiding entering into further details more in relation with pharmaceutical and biobanking requirements.</span></p>
<h2 style="text-align: justify;"><span style="color: #666699;"><strong>From NL42, the decision to implement a laboratory data management system is a strategic business decision</strong>. </span></h2>
<p style="text-align: justify;">It requires, as any major decision, the involvement of a certain number of people from different departments, with significant responsibilities and the end users. At first it may appear as a complex enterprise. In the end, it is about improving internal processes and reducing significantly your qualified personnel´s administrative time. It is about deciding to invest in the growing development of the company.</p>
<h2 style="text-align: justify;"><span style="color: #666699;"><strong>The two most critical key steps for a successful implementation of a data management solution project.</strong></span></h2>
<p style="text-align: justify;"><span style="color: #000000;"><strong>As in any project, the first step is to develop the User Requirements Specifications</strong> which is basically the list of requirements we aspire to implement. It is an essential step that any project cannot skip. It allows collecting in a structured way the needs of those who are part of the decision-making team, write down the current needs and apply for sufficient level of flexibility for the system to adapt to changes (market driven or internal strategic decisions) and to allow the incorporation of future needs without generating insurmountable levels of complexity.</span></p>
<p style="text-align: justify;"><span style="color: #000000;"><strong>The second essential step for setting up successful projects without surprises is certainly the &#8220;Execution&#8221; of it</strong>. Although the definition of requirements may sometimes end in an A4 sheet freehand drawing, the vast majority of projects fail in execution with the corresponding frustration, last minute surprises, delays and procurement of third-parties companies for developing and maintaining complementary applications not been completed during the initial project.</span></p>
<p style="text-align: justify;"><span style="color: #000000;">Our motto is <strong>&#8220;Making the Complex Simple”</strong> for the simple reason that our experience as technicians, in ancient times, business managers and international teams’ leaders has taught us that there is a unique single way to carry out complex projects. Firstly, by following an established methodology with discipline and secondly, by splitting up the project in so many small milestones as necessary to complete them in short times and achieve success in a visible and contagious way.</span></p>
<p style="text-align: justify;">
<p>L'articolo <a href="https://www.nl42.com/first-phases-of-a-lims-project/"></a> proviene da <a href="https://www.nl42.com">NL42 | Paperless Lab Academy®</a>.</p>
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