Data integrity had already become a top priority for the clinical and life science (pharma, biopharma, med device) sectors before the outbreak of COVID-19.
Data Integrity Guidelines
New guidance had been issued by both the FDA and the UK’s MHRA in 2018 with the goal of preventing, uncovering, and combating data integrity issues.
One of the key factors driving these rulings was the concern that data which had not yet been committed to media could be manipulated in its temporary state — either accidentally, or – in rare cases – intentionally.
These new guidelines for data integrity, refreshed for the modern world of data collection, demand more transparency and accuracy than ever before. As a result, it’s vitally important from a LIMS standpoint to ensure data is recorded and stored properly, and that any changes to (or attempts to change) the data are also recorded.
Fast-Forward to the Outbreak of COVID-19
In March of 2020, The FDA stopped foreign inspections and scaled back domestic inspections. Based on FDA 483 inspection data for the fiscal year, between Oct. 1, 2019 and Sept. 30, 2020, the agency conducted only 28 biologics plant inspections in 2020, compared with 116 the year before, and 349 drug facility inspections vs. 779 in 2019. And those number include the 5-month period before COVID-19 travel restrictions prevented the agency from conducting inspections.
In May 2020, the FDA announced that it would continue to “utilize and implement additional alternative inspection tools and approaches while postponing domestic and foreign routine surveillance inspections.”
While data integrity is always a part of inspections by the FDA and other regulatory agencies, pandemic conditions have given rise to remote inspections which are focused more heavily on data than in the past. Strong data compliance practices are also critical when rushing therapeutics to market. Informatics with data integrity and temporary data capabilities have thus become increasingly important.
How a LIMS Can Help
As pharmaceutical and biotech companies race to develop ever more advanced and more complex chemical entities and formulations, the pressure is growing to operate more productively and cost-effectively. Not only is compliance important, but speed and cost are factors that must also be considered. In response, modern companies are abandoning traditional, paper-based record-keeping practices in favor of preconfigured, pre-validated LIMS built specifically for the needs of today’s regulated manufacturers.
LabVantage has been actively engaged in data compliance for some time, including extensive communication with the industry during the public comment period for the FDA’s data integrity rulings. We’ve written broadly on the topic before, including here and here on the blog, in this Contract Pharma article, and in this white paper.
Our various discussions with customers, industry leaders and others on data integrity have led to significant enhancements to the LabVantage LIMS, streamlining the maintenance of lab data integrity and recordkeeping while adhering to compliance best practices.
LabVantage LIMS and Data Integrity
What are some of the steps we’ve taken regarding data integrity?
Cybersecurity Improvements
LabVantage LIMS has always been highly secure, with configurable security protocols and permissions that meet or exceed the requirements set out by the US Health Insurance Portability and Accountability Act (HIPAA), and the EU’s General Data Protection Regulation (GDPR). Version 8.6 takes an even more proactive approach to system security with:
- The adoption of SonarQube to evaluate and scan source code for potential vulnerabilities
- Greater use of Atlassian’s Jira software to track code more closely and increase the visibility of potential security issues during development
- A partnership with a third-party cybersecurity organization to perform ongoing, objective penetration testing of the software, among other development efforts.
Dynamic Auditing of Temporary Memory
To protect against accidental or malicious changes to data in temporary memory, LabVantage LIMS audits all user entries even prior to committing them to the database. The system has the option to prompt the user to provide the reason for the change, and can also require the user to re-identify him/herself with an e-signature if desired. Dynamic audits are available throughout the LIMS platform and can be configured to audit on any data entry page. These dynamic audits can be captured even if a user session is aborted.
Scientific Data Management System
The LabVantage SDMS immediately captures externally-generated data, whether from complex instruments, real-time data sources or incoming emails and other file sources (e.g., local drives, file shares). The systems also controls and secures this data against loss or modification.
Lab Investigation Module
The lab investigation module helps track non-conformances by assisting with the identification, investigation, and reporting of incidents throughout laboratory operations.
Analytics
LabVantage Analytics uses business intelligence with machine learning and artificial intelligence capabilities to create clear and relevant quality-related metrics (KPIs) on non-conformances, release history, certification and maintenance compliance and other issues – in some cases before they happen.
Configuration Management and Transfer
This aspect of the platform manages and controls changes you make to your LIMS configuration and master data. You can work within administration teams to make and document changes with full auditing, approval, and promotion of changes for validation and updates to production.
Data Integrity: A Must for Compliance, and Critical to Digital Transformation
Data integrity isn’t just a checkbox on a compliance checklist. LabVantage recognizes that data integrity and security are of paramount importance to an enterprise’s digital transformation. For more information on LabVantage 8.6, click here, or contact us today.
