quality assurance

As an information systems consultancy dedicated to successfully delivering lab-based information systems, we help our clients to overcome many different challenges. There are some important questions that we are frequently asked to evaluate.

In part one of this blog series, we’ll summarise the considerations to make when answering 3 common questions about lab informatics systems, all in the theme of ‘is a single system better than multiple similar systems?’

1. Should R&D labs use the same informatics systems as QC?

Here the context matters. If one were to generalise, R&D labs tend to be experiment-based, answering questions like ‘What ingredient changes in the product formulation will increase effectiveness and reduce environmental impact?’. On the other hand, QC labs are more focused on samples taken from production runs, and questions such as ‘Are the % composition of key ingredients within a production batch within specification?’

If we use the above generalisation and apply lab informatics thinking, in broad terms, ELNs are centred on recording experiments and therefore more suited to R&D. LIMS, being sample, test and results biased, are generally more suitable to QC labs.

However, it is not that simple. For example, perhaps one of the R&D labs provides analytical services to various teams executing R&D experiments – this type of ‘service’ lab is often better served by LIMS than ELNs.

The type of labs involved is not the only factor to consider. For example, CDS systems are generally applicable to both R&D and QC. The methods and use of the instruments may well vary across R&D and QC, but the instrument data systems can be exactly the same.

Finally, regulatory needs, specifically for QC can also be a driving factor in answering the question. We will consider this further in one of the following questions.

2. Should we implement a single global system or several more local systems?

When Scimcon first started nearly three decades ago, the focus within large multi-national companies was on implementing large, monolithic lab systems. This approach still has its place, particularly where the distributed labs are very close in terms of operational and analytical workflows.

Current thinking, however, looks to best support the diversity of lab workflows across global sites. While this should not mean a different system in every single lab, it should ensure some flexibility in selecting systems locally. This has several benefits, including a better informatics fit for each lab, and the increased local user buy-in gained by allowing flexibility.

However, against the background of the drive to increased data aggregation, data science and analytics, and AI/ML, this local approach can be counterproductive. It is therefore important to set standards and guardrails about how these systems are implemented, and how the data is structured and linked via reference data, so that consolidation into centralised reporting tools and data lakes is facilitated.

3. Should I have different systems for GxP and non-GxP work?

There is a well-used saying within regulatory-compliant organisations: ‘If a system contains just 1% of GxP data, then the whole system is required to be implemented, managed and maintained in a regulatory compliant manner.’

The first step to answering the question is to determine the delta between administering a GxP system, and administering a non GxP system. LIMS, ELN, SDMS, CDS and other lab informatics systems are often classified by labs as mission-critical. Most organisations wouldn’t countenance a lack of system administration rigour or releasing untested changes to mission-critical systems, so this delta may be lower than it first seems.

The next step is an open conversation with QA teams about the types of data being held, and the control systems that will be put in place. In the past, we have successfully taken a two-tier approach, where the administration procedures for non-GxP are simpler than those for GxP data in the same system. However, for this type of arrangement to be viable, a detailed risk assessment is required, and the ongoing management and control of the administration has to be very well executed.

Finally, before making the decision, it’s worth considering whether there are shared services or functions involved. For example, if the GxP and non-GxP work uses the same inventory management, it might be complex to get the inventory system interfacing and updating two systems simultaneously.

Summary

Hopefully, we have illustrated the importance of being clear about what your requirements are before answering these key questions about lab informatics systems. Each case is unique, and your decision will usually be based on a wide range of influencing factors. We help organisations to consider all of the options and roll out their chosen model.

Stay tuned for part 2 of this blog series, where we will look at the key question of how you can prepare your data for AI and machine learning.

The SmartLab Exchange Europe 2023, whichtook place from 22-23 February in Amsterdam, Netherlands, is one of the global meetings for lab informatics leaders. Scimcon continues its proud sponsorship of this event, as well as this month’s North American event in San Diego on 22-23 March, facilitating one-to-one meetings with a number of informatics customers from all major lab-centric sectors. The continued sponsorship of the event provides access to the community of senior R&D, Quality Assurance and Quality Control decision-makers from industry in both North America and Europe.

Feedback and voice of the Industry

Attending from Scimcon was co-founder and lead consultant, Geoff Parker, who took the opportunity to poll attendees and delegates of the attending organisations, to identify the current 2023 trends in the lab informatics industry. This includes R&D executives, Quality Assurance and Control leaders, and Regulatory specialists from organisations such as GSK, P&G, AstraZeneca, BioNTech, and more.

Summary of trends in lab informatics for the modern lab

In the informal poll of attendees at SmartLab Exchange, Scimcon has been able to identify key trends and themes that are important to the modern lab in 2023.

Of the total 73 delegates polled, 68 delegates – with budgets ranging between 500k to millions in GBP – volunteered which technologies they are interested in investing in within the coming 12 months.

Some of the key investment priorities included:

30.8% flagged digitalisation as a priority in 2023 (21 delegates)
20.6% noted automation as a priority investment area (14 delegates)
13% cited LIMS as 2023 priority (9 delegates)

When asked about additional investment priorities, 7 delegates stated that the following areas were also of interest this coming year:

Digitalisation, Agile process, AI
Automated Analytics/Analysis
Harmonisation
People/Talent
Risk assessment, based methodologies, toxicology, product expertise
Reducing QC Testing
Infrastructure

Attendees also ranked their interests and what topics they wanted to address at SmartLab. As illustrated, lab automation, and AI/ML in particular, are high priorities for lab leaders in 2023, with other high priority areas including data quality and integrity, instrument connectivity and IoT, and data integration.

This year’s event also saw the Scimcon team hosting the opening panel discussion, ‘What is the future for human scientists as AI and ML deliver the promised step change in laboratory practice?’, where key opinion leaders were invited to participate in the discussion to kick off the event. Panellists at the European conference were Edith Gardenier from Genmab, and Andy Phillips and Robin Brouwer from AstraZeneca.

Geoff summarises “As lab informatics consultants with a global customer base in leading lab centric organisations, it is important to us to check in frequently with influential decision-makers from the lab. SmartLab Exchange offers us a useful ability to poll the attendees and see trends that will impact the modern lab decision-maker, and will help us at Scimcon to hone the way we partner with our customers. The attendees we spoke to were split between R&D and QA/QC – with 43% in R&D, 24% in Quality, and 16% in both. We very much look forward to catching up with delegates at the US event in March, and it will be interesting to see how trends and priorities differ or align between the US and Europe.”

SmartLab Exchange is attended by invite-only decision-makers. The unique invite-only format of the event means that both sponsors, speakers and delegates can access a closed community that meets their individual needs.

Scimcon is proud to continue its sponsorship of the SmartLab Exchange Europe and US events in 2023, and the team is excited to connect with delegates at the US event on 22-23rd March 2023.

To learn more about how Scimcon supports science centric organisations with data solutions and lab digitalisation, or to organise a meeting at the US event, contact us today.

To catch up on the themes discussed in our EU panel discussion, you can read our blog here.