Software for Validated and Compliant Systems

If an automated system is being developed for a regulated area the custom automation software must be designed and written to follow a set of recognised standards. We at Aitken Scientific have a detailed quality system which follows the ISPE GAMP standard, and have many years of software engineering experience putting it into practice.

We have been audited and approved to produce GAMP work for some of the major pharmaceutical companies.

GAMP is now at version 5, which covers the latest guidance from the FDA. The FDA's risk based approach is designed to reduce your validation effort, as it allows full validation to occur only in the higher risk areas, while lower risk areas can be covered less rigorously. However, assessing risk has now to be added to the workload. We can apply risk based techniques to your software validation.

Do any of the following apply to your automation software specification?

• A need for a validated automation software package
• 21 CFR Part 11 compliance - more information...
• Carefully written and well structured documentation
• Comprehensive custom software testing plans
• A pragmatic approach - we adopt a sensible, efficient and cost effective approach to all validation activities

The machine pictured is a Card Cutting, Slitting and Sorting machine used to make diabetic test strips. Aitken Scientific provided the supervisory and high level control software for this machine, delivered to FDA standards. The custom scientific software uses our 21 CFR Part 11 module. For an overview of this validated system, click here

For further information contact us.