Whether you are building a new facility or expanding to your existing operations; installing new capital equipment; re-validating existing equipment/utilities or you have been challenged with compliance deficiencies with your manufacturing operations/equipment, facility, or utility, turn to the experts at Regulatory Compliance Associates® Inc. We can develop and tailor the appropriate facility validation program to help.
Manufacturing Support
RCA can assist with the entire validation life cycle continuum—starting with the validation strategy / validation master plan through purchase, qualification, and commissioning. We have validation experts that can help and guide you from design qualification, and user requirement definition through factory / site acceptance and through commissioning and qualification.
- Our service solutions include:
- User requirement specification (URS)
- Factory acceptance test (FAT)
- Site acceptance test (SAT)
- Installation qualification (IQ)
- Operational qualification (OQ)
- Process qualification (PQ)
Expertise in validation of:
- Equipment
- Facilities
- Utilities
- Computer systems
- Controls supporting the areas of:
- Manufacturing
- Laboratory
- Utilities
- Processes
- Facility validation of existing equipment and operations to stay in compliance
- Remediation of quality system deficiencies:
- Manufacturing process
- Laboratory
- Equipment
- Facility
RCA can provide Strategic Consulting and services in the following key areas:
- Product Life Cycle Management
- Outsourcing & Staff Augmentation
- Manufacturing and Facility Validation
- Mergers and Acquisitions / Due Diligence
To begin the Regulatory Compliance Associates scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. You may also email us at [email protected].