LabLog is tailored for the needs of the biotechnology and pharmaceutical industries. Our built-in tools simplify FDA 21 CFR 11 compliance.

What is FDA 21 CFR 11?

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.

Audit Trails

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 think that we have come up with the best solution for automated management of audit trails.
LabLog uses a two-tier system to capture changes to critical data and log all activity that is performed on our platform.

Systems Access Controls

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.

Local and Cloud-Backed Record Protection

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.

Secure Time-Stamp Generation

Generating time-stamps for creations and edits has never been easier. LagLog automates the secure time-stamp generation process.

Our security measures are just one part of the defense in-depth that you need to stay FDA 21 CFR 11 compliant. We’re committed to client success, so we offer the following recommendations.

Develop In-house Procedures
To protect your networks and the data on them, we suggest conducting a comprehensive risk analysis and then putting policies, procedures, and controls in place to ensure confidentiality, integrity, and availability of your electronic records.

Training and Education
Unfortunately, users are often a major vulnerability. It’s crucial to conduct regular IT security training sessions to raise awareness for those who create and access electronic records.

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. Be sure to monitor access rights to prevent privilege creep.

Create Strong Internal Policies
Your organization should have strong internal policies in place that hold individuals accountable to deter record and signature falsification.