21 CFR/GxP Compliant Software
Regulatory compliance made easy
AuditSafe is TotalLab’s answer to one of the major pain points in introducing regulatory compliance in a manufacturing site – difficulty in integrating the solution within your existing network.
Here at TotalLab we’ve been creating and selling FDA 21 CFR Part 11/GxP-compliant software for the pharmaceutical and other regulated industries (such as hospitals) worldwide for years now with an incredibly robust and feature-rich software solution however the hardest part of the installation and validation of the software on site has always been navigating the existing users network/IT configuration.
From blocked ports to user permission headaches preventing end users from setting up the software themselves without their own IT professionals to hand, we thought there must be an easier way for our users to become compliant.
AuditSafe provides users with the usability benefits of a pre-validated cloud-compliance solution without having to sacrifice data security, 21 CFR/GxP compliance or risk breaching local data sovereignty laws.
TotalLab’s 21 CFR Part 11/GxP Compliant Module
Users of our image analysis software may require a 21 CFR Part 11/GxP-compliant version where access is tracked and recorded in a secure environment. Talk to us about ensuring your compliance with 21 CFR part 11 and EU Annex 11, whilst using our software.
It does this by
- Generating a two-factor authentication for project approvals and sign-in
- Ensuring data integrity and authenticity of results with control over user privileges assigned to each electronic signature
- Providing emergency access to projects if locked out
- Providing the ability to create secure and unique IDs, with the option to have password expiry dates
- Integrate with Windows active directory logins and passwords
Our GxP Module eliminates project overwriting through our check-in / check-out system. This means that analysts can collaborate on a project, without risk of overwriting each other’s contributions, leading to a streamlined and easy-to-use process.
Maintain data integrity with comprehensive electronic reports
Our solution provides an easy-to-read, time-stamped audit trail which contains a complete history of projects created, retrieved and approved.
With our full analysis audit trail/report you can easily reproduce analyses.
The solution also comes equipped with an access log. This automatically tracks critical signature and system access actions such as:
- Changes to user privileges
- Login fails
- Emergency logins
- The action of changing logins
All of this information is held to hand, so if called upon you can easily demonstrate your compliance through electronic reports.
Maintaining compliance with the Electronic Code of Federal Regulations.
21 CFR part 11.10(d) refers specifically to secure sign-ins and limiting system access to only authorised individuals. This includes controlling who can use the system, sign off a project and view and alter a record.
Our compliant system has the following features to enable users to meet compliance:
- GxP Module can detect and record unauthorised attempts to gain access to the system
- It only allows access to authorised individuals who have a valid username and password
- Based on a state of actions (operational checks) and user permissions (authority checks) certain actions or sequences can be automatically disabled to maintain the integrity of the system
- For audit and security purposes, all electronic signatures remain permanently associated with the electronic records, including date, time and reason for approval.
Our GxP Module can come bundled with the 21 CFR enhanced versions of our class- leading image analysis products:
Phoretix 1D is our easy-to-use, fully automated 1D gel image analysis software which allows you to analyse SDS-PAGE and Immunoblot experimentsFind out more >
SpotMap is a 2D gel HCP coverage software tool for analytical and biologic development and bioprocess improvement.Find out more >