This set of regulations from the U.S. Food and Drug defines criteria under which electronic records and signatures are considered reliable, trustworthy, and equivalent to their paper equivalents. The entire set of regulations may be found at the FDA website.
In the recently released draft industry guidance titled, "Use of Electronic Records and Electronic Signatures in clinical Investigations under 21 CFR Part 11 - Questions and Answers", the FDA provides the following recommendation:
Sponsors and other regulated entities often perform audits of the vendor's electronic systems and products to assess the vendor's design and development methodologies used in the construction of the electronic system or the product, as well as the vendor's validation documentation. To reduce the time and cost burden, sponsors and other regulated entities should consider periodic, but shared audits conducted by trusted third partied."
LabLog regularly undergoes independent audits performed by qualified third-party accredited assessors with regard to 21 CFR Part 11. LabLog provides customers with access to the latest audit reports, which customers may review during their vendor assessment process.
In recently released guidelines by the FDA the agency emphesized the importance of Electronic record audit trails during inspections.
At LabLog we have given a lot of consideration to audit trails and we have created a robust solution for automated creation of audit trails. All audit trails are retained for 10 years or a period chosen by the customer. Requesting audit trails for a record is as simple as clicking a button in the LabLog app.
LabLog uses a two-tier system to capture changes to critical data and log all activity that is performed on our platform.
Set access controls according to your organization’s security posture. LagLog uses role-based access controls so that administrators can limit data access to authorized individuals.
We include built-in compliance roles like reviewer and approver, and administrators can also create custom roles for their teams. Plus, we encrypt all records to give data owners maximum control over distribution and access rights.
Our electronic notebook software prioritizes data security. We provide a full audit trail and full redundancy so that you can be certain that your laboratory complies with all necessary regulations. You can read more about our data security policy here or download our product whitepaper.
LabLog makes it easy to request and sign records. Signature information is captured and displayed according to the requirements of 21 CFR Part 11.
Generating time-stamps for creations and edits has never been easier. LagLog automates the secure time-stamp generation process.
At LabLog we have created a set of SOPs specifically for compliance to Title 21 part 11. Furthermore, our entire team undergoes regular training to ensure that everyone is aware of the latest requirements and how to meet those requirements within their role at LabLog.
Trust Criteria and Cloud Controls Matrix (CCM)
The Trust and CCM Criteria pertain to trust service principles and criteria that are met by control activities provided by LabLog.
We identify the shared responsibilities between Labog and its life sciences customers for meeting regulatory requirements, such as FDA 21 CFR Part 11 Electronic Records, Electronic Signatures (21 CFR Part 11).
Limit Systems Access to Authorized Users
Our comprehensive access controls give you the tools you need to give your users the exact amount of privileges that they need to do their jobs.