Whether you are building a new facility or expansion 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 cGMP validation program to help.
We perform an array of validation services, such as:
- We can assist with the entire validation life cycle continuum—starting with the validation strategy/validation master plan through purchase, qualification, and commissioning
- We have cGMP experts that can help and guide you from design qualification, and user requirement definition through factory/site acceptance and through commissioning and qualification. We have experts in user requirement specification (URS), drug specification (DS), factory acceptance test (FAT), site acceptance test (SAT), and installation qualification / operational qualification/process qualification (IQ/OQ/PQ) summary reports
- Expertise in the validation of: equipment, facilities, utilities, computer systems, and controls supporting the areas of manufacturing, laboratory, utilities, and processes
- Comparability protocols and re-validation of existing equipment and operations
- Remediation of quality system deficiencies related to your laboratory, manufacturing process, equipment, or facility
