Manufacturing Consultant Services
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
Our broad range of Pharmaceutical Strategic consulting services include:
- Pharmaceutical Manufacturing
- Mergers and Acquisitions / Due Diligence
- Outsourcing & Staff Augmentation
- Change Management
