The Integrity of Your LIMS’ Data
The whole idea of ‘data integrity’ is a big deal for LabVantage. We see our top job and key responsibility as ensuring the integrity of the data in your LIMS.
Integrity…data…LIMS – that’s our job. This has remained unchanged since the very first LabVantage LIMS was launched several decades ago.
But data integrity (in the FDA sense of the word) is a much more recent development – one which can challenge the very functionality and usability of an existing LIMS. We’ve covered the topic in earlier posts, including discussion of the impact of temporary memory on audit trails and data integrity.
Earlier this summer, Contractpharma.com published an article on data integrity (A Brave New World of Data Integrity) by LabVantage’s Bob Voelkner, our VP Sales and Marketing. The article discussed the contract pharma manufacturing (CRO/CMO/CDMO) industry, and the impact of last year’s FDA guidance on data integrity. Since data integrity is heavily dependent on a lab’s informatics, there were a couple of points in the article that bear repeating.
Dynamic Auditing of Temporary Data
Dynamic auditing is a rethinking of the industry’s traditional approach to data retention. Industry has always considered something as ‘data’ once it has been saved to durable media.
The FDA’s concern was that in its temporary state, data could be manipulated – either accidentally or (in rare cases) intentionally –since it has not been committed to media. As Bob relates in the ContractPharma article, “A mistype can be fixed, a value corrected, or, as regulators fear, a noncompliant result deliberately changed in order to meet specifications, all without detection. “
The result of these concerns is dynamic auditing—essentially, tracking all changes to temporary data. This functionality has become a key theme of data integrity standards, and it is changing the way one pharmaceutical industry sector manages their data.
Pharmaceutical Contract Manufacturing Organizations (CMOs)
If maintaining temporary data as records sounds like it requires a great deal of effort, imagine how pharmaceutical contract manufacturers feel. They have multiple customers with complex, constantly-evolving, data-heavy projects.
Contract manufacturers have become firmly entrenched in the pharma (and biopharma) industry, as companies back away from in-house manufacturing in favor of drug discovery and development. With the 30+ year growing wave of CMOs has come heightened regulatory scrutiny. Data integrity is just one of the more recent pharma manufacturing characteristics which have attracted the interest of regulators.
Contract manufacturers are facing mounting data challenges – both from a regulatory standpoint but also due to the multitude of customers and projects they handle.
With data subject to the errors and inconsistencies of manual record-keeping, increasing regulatory oversight, and the need to constantly improve operational efficiency, contract pharma organizations are updating their data practices – and in many cases, their LIMS infrastructure – to streamline data collection and storage and comply with the most recent guidance.
LIMS, Data Integrity and Contract Manufacturing
In the ContractPharma article, Bob Voelkner also discussed the ‘data accuracy’ rationale behind the pharma manufacturing industry’s shift to compliant informatics systems:
“Manual, paper-based record-keeping, once the mainstay of CMOs, is facing obsolescence. More and more labs are migrating away from the porous nature of this traditional approach, in which integrity is lost with each transcription error, each small deviation in standard procedure, each frog-leap from one siloed system to another.”
An advanced LIMS platform plays a pivotal role in maintaining data integrity, automatically capturing entered-but-not-saved data, and requiring a reason for changes made in temporary memory. This provides a clean, transparent, compliant and comprehensive audit trail.
With regulatory pressure increasing on the contract pharma industry – combined with the need for better operational efficiencies – it’s the right time for CMOs to re-evaluate their traditional data management workflows and adopt tools which ensure data is complete, secure, durable and broadly available to sanctioned users. The objectives?
- Automation of data collection.
- Ensuring data organization & consistency.
- Secured data – potentially across multiple sites.
- Using highly-reproducible and efficient workflows.
Advanced Informatics to Ease the Data Burden
Because of the breadth of data they manage on behalf of clients, most CMOs are keeping up with regulatory guidelines through the use of advanced laboratory information systems. They are also adopting a new approach to data to align with new regulatory standards:
“CMOs around the world are rallying behind the principle that all data should be attributable, legible, contemporaneous, original, and accurate (qualities known by the acronym ALCOA), as well as consistent, available, enduring, and complete (ALCOA+).”
Want to learn more about data integrity and temporary data? We’re happy to help! Contact us here.