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TotalLab Version Control

21 CFR Ready Software

 

Secure, end-to-end tracking and collaboration software that helps traceability, data integrity and reproducible analysis for GxP regulated labs.

TotalLab version control provides the ability to comply with 21 CFR part 11 regulations surrounding system access, electronic records, audit trails and electronic signatures for 1D, Western blot and 2D coverage analysis. Collaboration is built into Version Control, your team can easily work together on an analysis from data creation to final distribution.

Integration with CLIQS

CLIQS is a simple 1D gel image analysis software using your DNA, RNA and protein samples including Western blot analysis.

Integration with SpotMap

SpotMap is a 2D gel HCP coverage software tool for analytical, biologic development and bioprocess improvement.

Key Version Control Features:

Maintain GMP electronic signature compliance

Version Control provides the controls to comply with the FDA’s requirements for electronic signatures.

  • Generate a two-factor authentication for approvals and sign ins as required by the FDA
  • Data integrity and authenticity of results with administrative privileges assigned to each electronic signature
  • Emergency access in-line with 21 CFR regulations
  • Create secure unique ID’s in Version Control including password expiry dates if required

Integrated collaboration means no project overwriting

Our check-in check-out system allows analysts to collaborate on a project – all without overwriting each other’s contributions to create a more streamlined and easy-to-use process.

Maintain data integrity with comprehensive electronic reports

Version Control provides the ability to comply with the regulations describing audit trails part (21 CFR 11.10(e)).

  • You’ll get an easy-to-read, time-stamped audit trail containing a complete history of projects created, retrieved and approved.
  • A full analysis audit trail/report including all analysis interventions to easily reproduce the analysis.
  • An access log which automatically tracks critical signature and system access actions such as changes to user privileges, login fails, emergency logins, and the action of changing passwords.

Secure sign ins and limiting system access

Version Control aids compliance with (21 CFR 11.10(d)) of the Electronic Code of Federal Regulations. The regulations describe control over limiting access to the system and ensuring that only authorized individuals can use the system, sign a project, view or alter a record. Part 11 compliant systems must also detect unauthorised attempts to gain access to the system.

  • Version control limits access to authorized individuals only with a valid username and password.
  • Disabling of certain actions or sequence of actions based on a state of actions (operational checks) and user permissions (authority checks).
  • All electronic signatures remain permanently associated with the electronic records, including time, date and reason for approval.

We’ve created some useful compliance documentation and downloads

Version Control Compliance Guide for 21 CFR Part 11

(For Regulation Sec. 11.10 – 11.300)

This document presents the technical features of Version Control in regards to FDA 21 CFR Part 11 and how these individual regulations can be satisfied with Version Control to help your organisation comply with the Food and Drug Administration’s FDA 21 CFR 11 regulations.

How to Configure System Security in Windows for GxP Compliance

(For Regulation Sec. 11.10 – 11.300)

If you are operating in a 21 CFR Part 11 compliance laboratory then setting up Windows security becomes a major component in setting up your system. Below are some key takeaways we think will help ensure you, the administrator setup your Windows security correctly.

How to Configure Electronic Signatures for GxP Compliance

(For Regulation Sec. 11.100 – 11.300)

If you are using Version Control or any other software to aid 21 CFR Part 11 and using electronic signatures, it is important that your electronic signatures are setup is correctly in order to comply with the FDA 21 CFR regulations.

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