Computer System Validation | SOLABS | 21 CFR Part 11

Computer System Validation

SOLABS takes a ‘Shared Responsibility’ approach for the system lifecycle and maintenance of SOLABS QM. Our validation package has been developed and is maintained with this philosophy firmly in mind.


See our Validation Package

Where do we start with Computer System Validation and SOLABS QM?

Assuming you have a risk-based approach to validation, you will certainly agree that SOLABS QM would fit in the “needs to be validated from end to end” category. This complies with the rules and guidelines set out in 21CFR Part 11, Annex 11, PIC/S and/or GAMP.

To accommodate this risk-based validation approach, we provide our clients with a full and complete validation package. This package includes all of our qualification material, including protocols and executed Test Scripts for the core functions.



Okay, so it sounds like this will get me a validated system in an isolated environment, but what about my working environment, live and in real time?

Your organization will fall into one of the following TWO categories:


1. Your Organization already has validated systems installed:

System Access and Security

SOLABS QM itself is a secure system, where you control access provision to the system. SOLABS QM adapts well to your current procedures, as it can be configured to authenticate users using your active directory. This ensures end-users’ passwords are managed through your existing policies. SOLABS QM also houses reporting features that allow you to perform periodic reviews of user access rights to the system.

Change Control

We provide supporting information for your change control each time a change is made to SOLABS QM. We perform the technical interventions, and provide full records of these interventions to ensure we are in compliance with best practices for change control. Our Client Request process is used to log all system changes, and provides a detailed history of the evolution of your SOLABS QM system.

Backup and Recovery Procedure

We will comply with your existing procedures and handle the backup mechanisms on your behalf, as well as identify exactly what needs to be included in your backup routines. You can also benefit from our cloud offering, but strictly for offsite backup and recovery purposes, if you so choose.

Disaster Recovery

Our infrastructure relies on standard Microsoft software (Windows, My SQL, SharePoint).It is generally deployed in a series of virtual machines which allows you to benefit from standard disaster recovery features. You could also benefit from our cloud infrastructure for your disaster recovery plan, via offsite-stored pre-integrated virtual machines.

Incident Management

Every Level II issue reported to SOLABS is logged as a client request. We provide investigation reports on issues and answers on complex queries.



2. Your Organization does not have validated systems installed:

You Develop System-Specific Procedures

We recommend you develop system-specific procedures to enable you to rely on our support when building your procedures for the topics covered above.


What about Training and Operations?



And finally…

What if we choose your SOLABS QM Cloud offering?

You will receive the same exemplary level of support from SOLABS. The system remains a secure system, validated and maintained.

The difference here is that we will generally take more responsibility for support of the environment, i.e., qualification of the infrastructure, backup and recovery procedures and, optionally, the disaster recovery plan.