What is Part 11?
FDA 21 CFR Part 11 compliance is a regulatory requirement that companies in the pharmaceutical, biotech, and medical device space that work with electronic records must adhere to in order to ensure that electronic records and signatures meet the same standards for authenticity, integrity, and confidentiality as paper records. In essence, Part 11 compliance aims to create a level playing field where electronic records are just as trustworthy as their paper counterparts.
Part 11 of the Code of Federal Regulations (CFR) sets out the requirements for electronic records and signatures in GxP-regulated environments. Compliance with Part 11 is therefore a critical factor in ensuring the safety, efficacy, and quality of pharmaceutical products.
The significance of Part 11 compliance lies in the fact that it provides a framework for ensuring that electronic records are reliable and accurate, and that they can be traced back to their original source. This is particularly important in the healthcare industry, where data integrity and accuracy are paramount, and where patient safety is at stake.
What did ixlayer do to become compliant?
The certification process involved a thorough evaluation of our systems and controls by an independent third-party consultancy and auditor, ProPharma Group. Part 11 compliance requires ixlayer to maintain specific technical and procedural controls, such as access restrictions and data encryption, to ensure that electronic records are secure, accurate, and tamper-proof. We also established procedures to ensure the integrity, protection, and retention of electronic records.
What was ProPharma Group’s Approach?
ProPharma Group conducted an independent, third-party assessment of ixlayer’s software application, system design, testing documentation, and supporting processes to identify the changes required to achieve Part 11 compliance.
ProPharma Group’s assessment included:
At the conclusion of this assessment, ProPharma Group provided ixlayer with a report that identified the specific system features and procedural controls needed for alignment with Part 11 requirements.
Once ixlayer had deployed the new system features and procedural controls, ProPharma Group conducted a second assessment and authored a white paper detailing ixlayer’s state of compliance with Part 11.
What does this mean for you?
One of the key benefits of ixlayer achieving Part 11 compliance is that it helps enable biopharma partners to innovate with confidence since it streamlines regulatory inspections by providing a standardized framework for electronic records. For study sponsors in clinical trials, the ixlayer platform is now an even more trusted resource for their business.
Part 11 compliance will help ixlayer increase efficiency by eliminating the need for paper-based records. This can result in improved productivity and faster decision-making, allowing us to better serve our customers.
Overall, Part 11 compliance is a critical requirement for companies conducting clinical trials in the pharmaceutical, biotech, and medical device space in order to ensure the integrity of clinical trial data. Compliance with Part 11 will help ixlayer improve data integrity, streamline regulatory inspections, and reduce costs for our partners. This certification, in addition to our HITRUST, SOC2, HIPAA,GDPR, PHI Data and DoD IL5 GovCloud certifications, demonstrates our commitment to quality and compliance, reduces the risk of non-compliance and data breaches, and can lead to increased operational efficiency. As such, it is a critical component of the overall quality and compliance strategy at ixlayer.
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