Discussions at the 12th edition of the PLA® Conference Europe 2025

The PLA® Conference is pleased to announce its 12th European edition, which will take place on 18 and 19 March 2025 in the city of Milan, Italy, at the Hotel NH Milano 2.

The conference is the place to be for anyone thinking of implementing, consolidating, integrating, simplifying digital processes in their labs, and improving data-driven decisions. Data, Processes, People, Technology, and Compliance are the backbone of the program of each edition.

A two-day event that includes:

– Plenary talks and panel discussions

from industry leaders who share their visions and use cases, explain their strategies for tackling a specific project and share their lessons learnt along the way.

– Product deep dive and Interactive  workshops

where our sponsors present their latest solutions and their subject matter experts share their experience and knowledge on specific topics.

– Networking at the Exhibition Hall

a true showcase with high-quality networking opportunities to gather in-depth information with colleagues, speakers, and vendors.

A unique opportunity only possible thanks to  the support of the PLA® partners. More than 60 solution and service providers sponsoring all editions around the globe since 2012.

The project was launched in Europe in 2012 with the aim of creating a platform for discussion that ensures a collaborative atmosphere between suppliers and visitors.

The PLA® conference program is intended for managers and executives from R&D, QC, OpEx, IT and QA departments in the bio/pharma, cosmetics, biotechnology, service labs, chemicals, consumer goods, food and beverage sectors.

In 2023, a long-standing project that had unfortunately been delayed by the pandemic was finally realised. The PLA® conferences are now present in Europe, India, and the United States. The 2023 editions proved to be strong and robust. The programs addressed the challenges of successfully implementing digital lab transformation initiatives. The discussions aimed to question some paradigms and encourage the shift from an application-centric mindset to a digital one,” comments Isabel Muñoz-Willery, Event Director at Paperless Lab Academy®

Free Registration now open

Join the discussions!

L'articolo Press Release: PLA® Conference 2025 EUROPE proviene da NL42 | Paperless Lab Academy®.

Discussions at the 11th edition of the Paperless Lab Academy® Conference Europe

The PLA® Conference is pleased to announce its 11th European edition, which will take place on 12 and 13 March 2024 in the city of Milan, Italy, at the Hotel Meliá Milano.

The conference is the place to be for anyone thinking of implementing, consolidating, integrating, simplifying digital processes in their labs, and improving data-driven decisions. Data, Processes, People, Technology, and Compliance are the backbone of the program of each edition.

A two-day event that includes:

– Plenary talks and panel discussions

from industry leaders who share their visions and use cases, explain their strategies for tackling a specific project and share their lessons learnt along the way.

– Product deep dive workshops

where our sponsors present their latest solutions and their subject matter experts share their experience and knowledge on specific topics.

– Networking in the Exhibition Hall

a true showcase with high-quality networking opportunities to gather in-depth information with colleagues, speakers, and vendors.

– Deep Dive Workshops

to deepen knowledge on specific topics.

A unique opportunity that is only possible with the support of the PLA® partners. More than 60 solution and service providers sponsoring all editions around the globe.

The project was launched in Europe in 2012 with the aim of creating a platform for discussion that ensures a collaborative atmosphere between suppliers and visitors. The PLA conference program is intended for managers and executives from R&D, QC, OpEx, IT and QA departments in the bio/pharma, cosmetics, biotechnology, service labs, chemicals, consumer goods, food and beverage sectors.

In 2023, a long-standing project that had unfortunately been delayed by the pandemic was finally realised. The PLA® conferences are now present in Europe, India, and the United States. The 2023 editions proved to be strong and robust. The programs addressed the challenges of successfully implementing digital lab transformation initiatives. The discussions aimed to question some paradigms and encourage the shift from an application-centric mindset to a digital one,” comments Isabel Muñoz-Willery, Event Director at Paperless Lab Academy®

In 2024, the PLA® Conferences return with their 11th European edition, their 5th in India and their second in the USA.

Join the discussions!

L'articolo Press Release: PLA® Conference 2024 EUROPE proviene da NL42 | Paperless Lab Academy®.

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 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.

6 Factors for a successful Implementation of a Laboratory Information Management System

1.     Use the right approach during the purchasing phase

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.

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.

Your company has also a critical responsibility in the initial phases: clear company, business and technical requirements will avoid misunderstanding to ensure that:

• 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
• 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)
• 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.)
• List of available documentation from the provider (i.e. IQ, OQ, release notes, technical documents, project management documents, quality manuals, etc.)
• Future updates and upgrades should be clear since the beginning: how often? is the vendor’s support required? is additional validation required?
• The preparation of a 5 years investment projection, including software, services, validation, maintenance at minimum

2. Getting the team in place

The human Factor is key for a successful digital transformation project. 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.

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

3. Breaking Down the Elephant

Pure project management statement here. Clear milestones and achievable goals in short periods of time will drive you to success.

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.

4. Managing Change Requests

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.

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

5. Understanding your provider

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.

6. Planning for the Validation far in advance

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

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

• Project preparation
  • High-level project plan and project team information
  • Statement of Work
  • Software Licence Agreement or Subscription Agreement
  • Maintenance Services description
  • Information about the Quality System of the provider
  • Technical documents related to system integration and instrument connection
  • Business, technical, corporate, IT and regulatory requirements at minimum
• Project implementation
  • Detailed project plan
  • IQ, OQ and PQ
  • Validation Master Plan
  • Communication Plan
  • Change management Plan
  • Issue management

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.

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.

Should you have any questions do not hesitate to contact me: roberto.castelnovo@Nl42.com 

L'articolo 6 Factors for a successful Implementation  of a Laboratory Information Management System (LIMS) proviene da NL42 | Paperless Lab Academy®.

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’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.

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.

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.

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.

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: eData, we will focus on the initial raw data capturing at eConnect, correct and compliant handling at eManage, easy access to data insight for sound decision making at eDecide .

Two major concerns the auditors will focus on

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.

1)    Accessing the original raw data and its metadata

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.

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.

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.

2)    Assessing the Vendor, Documenting and Validating the computerised systems

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.

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.

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.

Join our project “Let´s Restart Together” , we can help you!

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.

Contact us 

L'articolo How to be sure that your Data Integrity project has fully covered your eData LifeCycle? proviene da NL42 | Paperless Lab Academy®.

Data integrity is not a new trend

You know that data integrity is not a new concept. You know of multiple examples not even related to the pharma industries that had a strong impact in the society. Like the one that happened in the automotive industry, with a catastrophic environmental fraud in cheating with emissions tests. The top management lost the job; billions were wiped from the company’s shares; and the country economy faced a big threat. In the Food industry, species authentication is also misleading the consumers in some occasions with incorrect labelling.

Today, we take numerous professional and private decisions along the day based on captured data, and we get used to trust them and the company behind those data. Once the information is acknowledged as incorrect, inadequate, even fraudulent, the trust is then broken. Unfortunately, the list of examples is long, and the final consequence always the same. A lack of trust impacts directly the final product and the company producing it.

Data integrity in laboratories

At the laboratory, you also might have run several internal meetings about data integrity, deciding how, what, when and who should be taking care of it. Too often the data integrity concerns focus on quality processes and data produced within the quality control department. We all then end up concentrating intensively in the potential gaps and risks that data silos might generate. Also, because, the auditors are getting extremely well trained in flagging the potential breaks directly at the source of a chromatographic raw data collection system.  Anyhow, multiple laboratory solutions and methodologies are available. The Internet of Lab Things (IoLT), the Integration of instruments (Ioi), the audit trails, the electronic signature and more, are technical solutions that once implemented ease the data flow and limit the breaks to any ALCOA+ listed concepts.

Unfortunately, too often, the preparation to an audit accelerates the buying decision process of a software solution with the aim of quickly saving the situation by showing to auditors an informatic dedicated tool implemented. The typical situation that cumulates so many “should not do it that way” which outcome results in a poor implementation with hybrid processes that increased the risks to data integrity breaks.

The right approach for data integrity is to review processes, incorporate new methodologies and make sure that new standard operative procedures are followed correctly with a good understanding of the benefits for the employee and the company to do it right. We started by being concerned about data integrity when what should be addressed is change management and enhancement of the company cultural awareness. An educational program is to be planned at corporate level involving all functions and departments.  The commitment of the company management is then a must to convey the correct message of recommended habits and attitude changes. The management commitment is a requirement to assure that the company is delivering reliable information. Management should instil the right attitude within the company providing guidance and leadership speaking about delivery of reliable information to the market.

Data integrity is, in the end, about Company Integrity

The commitment from management is critical, all markets should take data integrity as a serious issue as the risks of mishandling information are dramatic.

In commercial companies, we get quickly trained about how critical it is to get our computers and mobile phones backed up, generally connected to cloud applications storing securely the internal confidential information. No one’s goes for a coffee without blocking access to the personal computers with controlled unique password. How it happens that in other departments of the same company, password is easily shared if not completely visible on a simple post-it?
All employees should be committed to produce, handle and deliver accurate information. This is a long process which is not related to systems, technological solutions and processes. It is mostly related to corporate culture.
Company’s management should invest a significant portion of time in introducing a culture of reliability, quality and confidence that will generate trust within customers, suppliers and shareholders.

L'articolo Data Integrity, Company Integrity: a Management Commitment proviene da NL42 | Paperless Lab Academy®.

Technicians and analysts have the ability to connect and communicate with their analytical instruments, devices, and sensors. Capture of the data is automatic, controlled and compliant towards data integrity requirements. Interconnectivity allows such transparency to managers that it enables them to collect immense amounts of data and information from all points along the data lifecycle. The systems assist managers on the data analysis, by aggregating and visualizing information comprehensively for making informed decisions.

Nowadays, the technologies to make it happen are available. What is still missing is the adequate driving force for people to accept the changes in working with new digitalized processes.

For any company aiming for a strong competitive position in their respective market, the deadline for their digital transformation projects to be completed is almost overdue. This means that they should have already agreed and defined a long-term IT strategy, set clear goals and KPIs for their business intelligence management and have a clear understanding of the complete data lifecycle along their products lifecycles.

Digitized processes are easily implemented through dedicated informatics solutions. Yet the paperless project doesn’t end by just moving from paper-based process to less papers.  There is much more behind this word than a fancy ecologic meaning: complete control of your data from the moment they are created till the moment they´re archived. The industry4.0 requires adequate access to scientific data. Automation of processes and interconnectivity between the systems, instruments, and people are to be planned.

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.

The analysts would benefit from systems facilitating clear notifications about unexpected outcomes even before reaching out of specifications alerts.

As I like to say, if ever a laboratory is able to focus human attention in “review by exception” only, then the Laboratory 4.0 is born.

L'articolo Review by Exception: the ultimate Laboratory 4.0 objective proviene da NL42 | Paperless Lab Academy®.

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.

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.

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.

The first industrial revolution began through the use of steam power and mechanization of production

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’ cottages were brought together in a single cotton mill, and the factory was born.

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^th 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.

The second industrial revolution mastered the moving assembly line

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.

In the 20^th 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 per se 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^rd revolution.

The third industrial revolution made the manufacturing industry going digital.

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.

Four principles of the fourth industrial revolution

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. The principles: interconnection, information transparency, technical assistance, decentralized decisions.  That is the vision for the Fourth Industrial Revolution.

Those principles are the ones making the laboratory 4.0 of today.

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.

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.

If ever a laboratory is able to focus human attention in what I like to call “review by exception” only, the Laboratory 4.0 is born.

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.

Do not miss it! Registrations are free for visitors coming from companies that own a laboratory

Check out for more here: www.paperlesslabacademy.com 

L'articolo The Laboratory of the Industry 4.0 proviene da NL42 | Paperless Lab Academy®.

If the initial decisions were focused on implementing solutions to gain efficiency and shorten time to market, it is recommended to approach such digital transformation projects with clear understanding of the highlighted points below, avoiding frustrations and low return on investment.

Paperless laboratory – business process reengineering

A digital transformation project is the greatest opportunity ever to review processes and look for improvement. The process reengineering phase, far before selecting any informatics tool, is the most relevant moment that will make the difference.

The goal of the digital transformation is to convert laboratory processes and data management activities from paper to computerized systems. Processes should be then reviewed, modified and designed to clearly define how the entire data life cycle will be covered. In the laboratories, the data life cycle goes from the request of analysis to the emission of the certificate of analysis, yet storage and archiving is the very final step. The digitalisation process aims at generating a series of documents that put the laboratory in the position to manage requests and samples and to perform the required tasks.

A crucial step is to analyse the systems that are already part of the process, in order to understand if they are in line with the company requirements, the business needs, the corporate IT strategy or if they need to be upgraded or replaced. From there, processes and systems are mapped to visualize the flow of the data along its life cycle. This goes from the collection of raw data and metadata, management of the data, decision making and archiving.  The best solution could be composed of a unique informatic tool or a combination of systems, from a unique vendor or not whenever those systems can easily be integrated

Paperless laboratory – selection process

The selection of the systems that are required to cover the processes and which are fitting with the IT strategy is a key part of the implementation project. By selecting the informatics tool that suits their needs and the provider that commits for a trustable long-term relationship, the laboratory is creating the conditions for a successful implementation with a constant eye to the four major success factors: cost, time, quality and people.

The project team and scope should be clearly defined, the user requirements properly articulated, the project costs and time estimated and communicated to the company’s management.

In a whole digital transformation project, these 5 steps are the recommended ones when you have reached the moment to seek for the right solution.

If you opt for some consultancy support, these are the steps you should expect us to take you through for selecting your laboratory data management system. It is recommended to involve external resources which may help to design the selection in the most transparent way, adding on market knowledge which is critical to identify the potential vendors for each system.

These have been described in a previous article: “Five steps in the selection of a LIMS”

Paperless laboratory – benefits and costs

The proper implementation of a paperless lab would generate a significant number of benefits for the laboratory itself and for the company. However, it is also important to estimate the costs of the project.

Benefits:

• Time related benefits: the use of a paperless process reduces significantly the time required to complete the entire process. From 30 to 40% of man hours’ time is estimated be saved for each process
• Cost related benefits: the paperless processes are reducing the costs of maintaining paper-based process, such as archives.
• Quality related benefits: these benefits are related to the reduction of failures during the execution of the processes, such as manual transcriptions

Costs:

• Initial costs – related to the preparation phases of the project, including the selection process
• Implementation costs – the overall cost of products and services required to implement the system(s)
• Data migration costs – the costs related to the move of data from other systems already in use in the laboratory
• Validation costs – the costs to validate the systems
• Maintenance costs – typically an annual fee requested by the vendor
• Follow-up costs – the costs required to maintain the system updated according to the changes in business requirements, laboratory processes, etc

Paperless laboratory – system Implementation

Once the stage has been set, it is time for implementing the system. To guarantee a flawless process, formal project management initiatives should be considered during the execution of the activities. The level of project management skills required, may vary according to the complexity of the implementation. They would allow to drive the project to a successful completion according to the defined costs, time and quality. Moreover, proper communication should be established to ensure that the company management and all the stakeholders are informed about the project status.

Looking for some support on your selection process? Contact us and discover how we can help you.

L'articolo Setting the stage for a paperless laboratory proviene da NL42 | Paperless Lab Academy®.

5 steps to select your data management solution

In this article, we start with the assumption that you have walked your way to define your best fit to purpose solution by first mapping your processes, identifying your gaps and defining your “must have” requirements.

In a whole digital transformation project, these 5 steps are the recommended ones when you have reached the moment to seek for the right solution.

If you opt for some consultancy support, these are the steps you should expect us to take you through for selecting your laboratory data management system.

Step 1 in the selection of a LIMS: User Requirements Specification

Since the knowledge on available solutions in the market might sometimes be limited, it is highly recommended not to assume anything and never limit ourselves in putting down the so called “wish-list”. Even though it is sometimes easier to understand what you would not like to have rather that what you´d like to have, the user requirements document should collect all aspects that you´d like to see in the product but also the key points you need the company provider to fulfill adequately in order to trust on a long term B2B relationship.

The goals of this document are from one hand to define in the most accurate way what the system should do to satisfy the business and technical needs but also to describe the requirements for a satisfactory implementation.

The URS (User Requirement Specification) sets the scope of the project, provides references of the international, national and internal regulations that govern your company (i.e. industry, customers, auditors), sets the major benefits expected after the implementation of the selected solution and lists a set of categorized requirements. Requirements categories should include but not limited to:

• System and capacity requirements
• Corporate requirements
• Regulatory requirements
• Workflow requirements
•  Interface requirements
•  IT Support requirements

Step 2 in the selection of a LIMS: Request for Information

Once the URS are agreed amongst the team and stakeholders, it is time to reach out and call for an RFI (Request for Information). The RFI usually presents to the candidates the project scope, objectives and requirements categories along with the rules and expected timing of the selection process. The RFI goal is to perform an initial market assessment to identify the products and companies that would be able to deliver a satisfactory solution. As such we do align a set of 30 questions about the company and 50 about the product. The answers are evaluated and rated while questions are weighted in relation with their impact on the customer business activities and project goals.

At this stage we do realize a very open search that could end in having 30 or more companies applying to the RFI.  Even though the outcome is quite exhaustive, this first summary is very much appreciated as it gives a good comprehension of the market offering. As mentioned in the previous article:

“It is always a strong surprise for us to realize how little is known about the lab informatics industry by the potential buyers. Some providers considered as global market leaders are not even named in selection processes because their local presence is limited and their marketing strategy doesn´t reach them.”

From this first step, at least 3 solutions should be identified to move ahead in the selection process.

Step 3 in the selection of a LIMS: Request for Proposal

The final candidates selected from the RFI are then contacted to fulfill the Request for Proposal. The goal of the RFP is to receive a firm commitment from the vendors on the financial impact of the project and a clear definition on how the solution would be implemented. Further details are required from previous items mentioned in the RFI to gain granularity on technical aspects and also clear understanding of the level of commitment from the vendors with their project plan proposal. The information facilitated in the RFP should provide the basis of the final contractual agreement.

Step 4 in the selection of a LIMS: Demo Script

Meanwhile a technical presentation is arranged allowing the team to touch the solution and meet the vendor company. Since 3 to 4 demonstration sessions have to be planned in a reasonably short time frame, a demo script is highly recommended for the following benefits:

• Limit the vendor demo to the items of customer interest
• Concentrate the attention of the attendees to the listed items
• Facilitate a methodology to record if and how items have been demonstrated, seen and understood
• Facilitate a methodology to rate every item

The goal of a demo script is to remove, as much as possible, the emotional part of the technical presentations. By using a demo script, the different solutions are evaluated using the same principles.

Step 5 in the selection of a LIMS: negotiating and closing the contract

The goal of this last step is to sign a contract with the selected candidate that removes the typical ambiguities of the project implementation. The scope should be clearly defined, the costs and timing should be clearly stated in the contractual agreement. This is achieved by using the information provided by the vendor in the previous phases of the selection process and incorporate them into the contract. How product licenses are deployed and how implementation services are delivered should be mutually agreed. Payments should be clearly linked to project deliverables

Fact is that the benefits of running thought these steps are multiple:

• Market search is performed after that project scope and user requirements are clearly stated
• Vendors are evaluated based on their ability to support the customer, rather than their marketing efforts
• Vendors’ responses are measured using a unique approach
• Technical presentations are realized using the same approach
• The contract is signed largely reducing the ambiguities

Looking for some support on your selection process? Contact us and discover how we can help you.

L'articolo Selection Process II: 5 steps in the selection of a LIMS proviene da NL42 | Paperless Lab Academy®.

Readiness: key differentiator for the process of selecting a laboratory data management system

When approaching the selection process of the right laboratory data management system, in order to make this step a positive experience, the readiness comes as a result of your previous homework: team members’ commitment, stakeholders’ support, process mapping and clear requirements including the business, users and technical ones.

Avoid Acronyms when looking for your best fit to purpose laboratory data management system

Despite the title of this article, we’re very reluctant to use acronyms when mapping the processes and defining the user requirements. Yet most of the times customers have in mind to look for a named system, let’s say a LIMS, by default. Regardless we work in an R&D or a QC laboratory, when deepening attentively, listening to the business goals, identifying the “must have” and “nice to have”, we identify requirements that are above and beyond an acronym.

We often end up with a wish list that might bring you to think about a bit of ELN and a bit of LIMS, maybe a LES, and a bit of CDS without forgetting the critical interactions with the instruments, the corporate ERP and potentially with the MES of the production line.

This is ground for confusion, for you and the solution provider.

The choice of a “LIMS”: an important investment requires an accurate selection process

My partner, Roberto Castelnovo is used to provocatively say:

We visit three shops or more to purchase a pair of shoes. We spend months or even years before choosing a new house. While It takes only one good demo to purchase a software!.

The purchasing for a pair of shoes is based on somehow precise criteria: comfortable, nice look and feel, right color, fit for purpose running or gala dinner, according to the season, the climate where we live… Some of these criteria are measurable, hard to buy a shoe which is not our size, yet testing is critical as sizing happen not to be so standard. Other criteria are less measurable or not at all: Do I like how I look with them? The lifecycle of a pair of running shoes is just few months and the cost is relatively limited.

Certainly, more complex but the same process is followed when selecting a house: location, right number of bedrooms, etc. As it is related to a purchase that involves a significant amount of money, most of us is implementing, consciously or unconsciously, a selection process which drives to a couple of options and finally the decision. The lifecycle of a house is definitely longer than a pair of shoes and sometime it lasts our entire life. The cost involved is large and it is always an important decision.

Both processes sound logical, reasonable and expected for most of our purchasing actions.

Reality is that, when it comes to software, companies are too often purchasing without following the same logic. The lifecycle of such data management systems is long, extremely long… Some software products developed more than twenty years ago are still in use nowadays. The cost involved is large or very large when considering the internal costs of the implementation, the validation and the maintenance.

Even worse, too often we encounter companies that have purchased a laboratory data management system a couple of times in less than ten years. The reasons are typically that the software does not fit for the purpose, the company producing the software does not support the customers anymore, the technology behind the system is obsolete.

The conclusion: the investment is similar to a house; the process is similar to a pair of shoes or even less accurate. Why?

In the end, our experience tells us that the purchasing process is not a simple standard operation procedure to go through and involves in large percentage emotional responses to the interaction with the providers. Software products are intangible hence difficult to evaluate, vendors are able to present the product in such a way that it “appears as suitable” to support the customer needs.

Hence…How to handle the process to ensure that risks are minimized and the software fits with the expectations?

Our large experience working in commercial companies has allowed us to develop a methodology that permits to reach, with the lowest level of risks, the critical moment of signing the contract.

The human part of my laboratory data management system

Selecting a system in any country within Europe, even more in non-English speaking countries, brings a language parameter that sometime comes as highest requirement in the whole process. Proximity of the vendor and implementers, first line support in local language and local time working hours are critical for the final users and the IT business partners to feel comfortable in the long-term partnership with the vendor. The European complexity creates difficulties to international providers to get close to the market they want to address. It is always a strong surprise for us to realize how little is known about the lab informatics industry by the potential buyers. Some providers, considered as global market leaders are not even named in selection processes because their local presence is limited and their marketing strategy doesn’t reach them.

Lowering the barriers for international lab solutions providers to approach the European markets

As organizers of the Paperless Lab Academy, we are glad to receive, every year, more than twenty lab informatics providers sponsoring the event. Some providers are well-known and loyal partners of this initiative since the beginning yet we are proud to welcome new comers every year.

Young European companies bring innovative solutions, specific answers to key data management processes. They are eager to bring quality in their offering and they desire to do it right with their customers whom respond positively to their business model.

Others, international companies well implemented in the States, India, Canada or Australia, strong experience and skilled technical people, come to investigate the potential of the European market to position their solutions.

Despite the language barrier, the European lab informatics market offering has never been so promising. Just going to the big shop around the corner is not anymore, the only option for your laboratory, if you´re looking for the implementation of a solution lasting for several years, meeting your today and future business goals and providing you the flexibility to grow and the ability to compete.

L'articolo Selection process – How to select a LIMS proviene da NL42 | Paperless Lab Academy®.