Regulatory Compliance Associates computer system validation (CSV) experts and software engineers have extensive experience with 21 CFR Part 11 and the GAMP5 validation model to ensure that you have the appropriate level of documentation.
CSV is a methodology used to monitor the compliance of information and data integrity that meets regulatory compliance. Regulatory Compliance Associates expert consulting team can help you deliver quality control when replacing manufacturing paper records in regulated industries. We’ll propose strategies that can increase your quality culture and streamline your reporting.
Our list of services includes:
- 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
