How to become digital without dying in the attempt. 

Lab 4.0, digital lab, paperless lab, smart lab, connected lab, these are just a few terms from a long list of marketing speel designed to draw your attention to software solutions with promises that you will be highly efficient and competitive tomorrow.

If it were only as simple as downloading the very latest app to check the weather on your smartphone. Indeed, it is so easy to download any app recommended by a friend or from an attractive marketing ad. You can even try it out for 5 minutes and delete it as soon as the interaction is not intuitive enough or payment is required.

Why pretend that the selection of laboratory softwares can be approached in the same way?

What makes your lab valuable to your internal and external customers is your added value, expertise and knowledge, both enabled by your processes, your data and your people. This is exactly from where your digital transformation project should ever start. Because becoming paperless is much more than just implementing tablets for analysts to follow their standard operation procedures, eliminate transcription errors and double verification of every entry.

Start with the end in mind

The question should really be: What should paperless mean to you? And this is where the challenge begins. The digital transformation of your lab processes requires the team to diligently review them and imagine what your lab should look like. Also, behind the processes is the data. Draw your data lifecycle and follow the path. Demand easy access to enable assertive decision making and easy visualisation of key performance indicators at management level. Set clear corporate, business, and technical requirements at the start..

Get the right team in place

Ideally, your project manager, with the support of the project sponsor, will assemble a team with complementary skills and knowledge to ensure a total view of the requirements.

Your project manager should be able to attract knowledgeable and committed people. In the real world, this is not often the case. Project members are usually overloaded if they are not already involved in other projects. Senior management support is extremely important here to convey urgency and set business priorities which make room for digital transformation.

Be that as it may, do not overlook the change management aspect. The human factor is key to a successful digital transformation project. It is important to involve team members early in the project so that they buy into it and hopefully become advocates.

Use the right approach in the purchasing phase

Choosing a software system is not only about the product, but also about the company with which you are embarking into a long-term business to business relationship. Before buying there are some critical points to consider, and the vendor’s information should allow a quality assessment of their own processes and design of their software.

An important starting point is the proposed project plan and its granularity. The quality of this initial delivery will already tell you a lot, as will the vendor’s behaviour and responses to your request for information and request for proposal when moved into the next selection round.

Any vendor of software enabling your digital transformation needs to be as accessible, user focused and well documented as the very software they are selling.

Manage change requests and understand your provider

Your organisation has a critical responsibility when it comes to formulating clear corporate, business, and technical requirements and ensuring that misunderstandings about your expectations and surprises during the implementation phase are avoided.

However, there might be requests for change. Be aware that any changes required will have an impact on the project plan. There are no small changes outside the already agreed scope that will not have an impact on the time and cost of the project. They will also impact on the provider’s schedule, which may no longer be able to meet the original project plan milestones and deadlines.

Change requests need to be carefully considered in terms of how critical they are to the good functioning of the laboratory, how urgently they need to be implemented in Phase 1 or whether they can be deferred to Phase 2 to avoid further delay, and how much effort the provider needs to put in to meet the new requirement.

Get your data ready for Automation, AI and ML

Much has been written about Industry 4.0. The principles of the fourth revolution are interconnection, information transparency and decentralised decision-making.

By extrapolation, Labs 4.0 should ensure that instruments, devices, sensors and people are connected, communicate with each other and drive effective production.

The result is that data is automatically captured, controlled and collected in accordance with regulations, ALCOA+ and FAIR principles for scientific data governance and stewardship.

Interconnectivity gives managers such visibility that they can capture immense amounts of data and information from all points along the data lifecycle.

The systems assist managers with the data analytics, by comprehensively summarising and visualising information to make informed decisions.

If a lab is ever going to be able to focus human attention only on “checking for exceptions”, then Lab 4.0 is born.

Furthermore, a promising new level of complexity is attracting everyone’s attention: artificial intelligence and machine learning. However, those who have already had experience with it claim that the quality of the data is crucial and that too much time is invested in cleaning up the data before an AI project is even started.

So how about having a good handle on the entire lifecycle of your data to gain much more immediate insights from it?

For all companies aiming for a strong competitive position in their respective markets, the deadline for completing their digital transformation projects is almost overdue. This means that they should already have 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 entire lifecycle of their data.

Remain Compliant while implementing latest technology

At the Paperless Lab Academy to be held in Raleigh, USA on 15 and 16 November 2023, we will present a programme with a comprehensive storyline on how to take control of your data, what to consider when setting your strategies for digital transformation and much more.

In fact, when it comes to digitising R&D, QC or service lab processes that operate in regulated environments, discussions start (or better, should start) with how to properly manage the data generated in the labs. On the list of requirements set by the project stakeholders, compliance with industry regulations is certainly one of them and the measures to be taken are an essential part of the project plan.

Precisely because it is so important, discussions on quality are addressed in a special session at the #PLA2023USA consisting of presentations delivered by internationally recognised experts and followed by a panel discussion to further deepen the conversation with participants about risk management, computer software validation and data integrity, but… this will not be a training session on concepts or an endless list of guidelines… this session will mainly deal with the concept of quality culture within an organisation, challenging the paradigm of getting things done just for the sake of the next coming audit. Provocative but healthy and certainly respectful discussions.

Isabel Muñoz-Willery

Isabel Muñoz-Willery Ph.D. has 30 years’ experience in multinational companies serving life science laboratories in regulated markets. Founder of NL42 Consulting and is the owner of Paperless Lab Academy. The Paperless Lab Academy (PLA) is an initiative started in 2013 which has grown on reputation and followers along its activities. It is aimed at directors and managers of R&D & QC labs, IT, quality and operational excellence departments in pharmaceutical, cosmetic, biotechnological, life science, petro-chemical and chemical markets. The event focuses on building the ideal learning platform for all organizations involved in running laboratories, and in consolidating, integrating, or simplifying scientific data governance.

Leave a Reply

Your email address will not be published. Required fields are marked *