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TotalLab Version Control

 

21 CFR part 11 compliance for GMP/GLP labs from captured image to analysis

Version Control is an end-to-end tracking and collaboration system for CLIQS and SpotMap regarding 21 CFR Part 11 regulations. Providing the ability to comply with the 21 CFR part 11 regulations surrounding system access, electronic records/audit trails and electronic signatures. In addition to the tools to easily collaborate on your projects, helping your organisation work more effectively from creation to final distribution.

Integration with SpotMap

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

Integration with CLIQS

CLIQS is a simple software to analyse separation and quantification of your DNA, RNA and protein samples including multiplex Western blots.

Key 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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Answers to your Version Control questions.

Can I use open-source software with Version Control?

Yes. Widely used packages like Image J can be tracked in Version control and any image data can be approved using the collaboration tools.

Can I get a trial of Version Control?

We do not have a trial version of Version Control due to the nature of permissions and access to the system.  However, you can contact us to arrange a demonstration of all the features.

What kind of projects can I use with Version Control?

Regulated documents, CSV files. open source software, commercial software, image files from first creation/scanning to final usage.