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TotalLab Version Control
Integration with SpotMap

 

Helping 21 CFR Part 11 compliance for GMP/GLP labs from the captured image, analysis to sign off

What is SpotMap?

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

What is Version Control?

The first of its kind, Version Control is an end-to-end tracking and collaboration system for 2D gel & Western blot analysis for HCP coverage. You can track your projects from creation to final distribution, collaborate on your projects using our check-out check-in system and easily sign projects.

How does Version Control integrate with SpotMap?

Version Control is one single compliance system for all your 21 CFR part 11 needs. You can now track and collaborate, author and review your projects. Version Control allows protection, security and compliance for HCP coverage analysis.

Key Features:

Secure sign ins and electronic signatures

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

  • Maintain GxP compliance with two-factor authentication for approvals and sign ins.
  • Data integrity and authenticity of results with administrative privileges and user access management.
  • Emergency access and log-ins in-line with 21 CFR regulations.

21 CFR, Part 11 Electronic Signature Regulations:

  • Unique usernames and passwords are required for all users
  • All users must provide their unique ID’s to log onto the system and approve projects
  • Records all successful and unsuccessful system log-ons
  • Customisable user rights/permissions
  • Reason for approval is recorded along with signatures

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.

Maintain data integrity with comprehensive electronic reports

You’ll get an easy-to-read, time-stamped audit trail containing a complete history of projects created and retrieved and approved. A full HCP coverage analysis report and audit trail is included, featuring who, when and what was performed.

21 CFR, Part 11 Audit Trails and Electronic Reports:

  • Generate complete time-stamped audit trails, showing who and when projects are produced, opened and signed off.
  • Full audit trail and analysis report for HCP coverage analysis.
  • Electronic signatures attached to an electronic data-set are reported and cannot be altered or deleted.

Schedule your free demo today

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.

Answers to your Version Control questions

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.

Have any more questions?