Manufacturing Process and Software Validation for Pharmaceutical Companies:

We can offer significant expertise for the validation of manufacturing processes and software systems
Our expertise includes the preparation of validation procedures, specifications, protocols, execution of protocols, and preparation of validation reports. Our clients have realized significantly reduced validation costs and schedules by using our validation services for the following reasons:

1. Use of our risk based assessment methods that focuses validation efforts on critical control points (our strategy has been presented to the FDA and acknowledged as the appropriate model).
2. Use of our templates, guidelines, and procedures that improve productivity and ensure completeness of documentation.
3. Our expert knowledge of manufacturing process as well as software validation requirements supports optimal integration of these activities to reduce duplication and substantiate compliance.
4. Our coverage of Part 11 requirements ensures that all compliance concerns are addressed.

If you need assistance in optimizing your validation activities or just need resources to address a backlog of validation tasks we can provide expert and highly productive support services that eliminate your compliance concerns.