Regulatory Compliance Associates® Inc.’s computer system validation experts and software engineers have extensive experience with the GAMP5 validation model, to ensure that you have the appropriate level of documentation. System Validation analyzes the data integrity of your processes compared to all documentation needed in your Quality System. The benefit is the documentation helps ensure design outputs in the software development phase meet the necessary regulatory and compliance requirements. System Validation can also help confirm your software design controls meet the user experience needed for both internal support and external inspections.
- 21 CFR Part 11 Electronic Records, Electronic Signatures Validation
- Laboratory System Validation
- Network Infrastructure Validation
- Automation and Control Systems Validation
- Off-the-Shelf and Custom Software Validation
Regulatory Compliance Associates® Inc. (RCA) provides worldwide services to the following industries for resolution of compliance and regulatory challenges:
We understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of FDA-and globally-regulated companies.
As your partners, we can negotiate the potential minefield of regulatory compliance and private equity due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.