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.
Free Online DemoCollaboration is built into Version Control, your team can easily work together on an analysis from data creation to final distribution.
Free Online DemoVersion Control provides the controls to comply with the FDA’s requirements for electronic signatures.
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.
How it WorksVersion Control provides the ability to comply with the regulations describing audit trails part (21 CFR 11.10(e)).
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.
CLIQS is a simple 1D gel image analysis software using your DNA, RNA and protein samples including Western blot analysis.
Free CLIQS TrialSpotMap is a 2D gel HCP coverage software tool for analytical, biologic development and bioprocess improvement.
Free SpotMap Demo(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.
Docs(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.
Docs(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.
Docs