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 validation program to help.
- We can assist with the entire validation life cycle continuum—starting with validation strategy / validation master plan through purchase, qualification, and commissioning
- We have experts that can help and guide you from design qualification, 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 validation of: equipment, facilities, utilities, computer systems and controls supporting the areas of: manufacturing, laboratory, utilities, and processes
- Re-validation of existing equipment and operations
- Remediation of quality system deficiencies related to your laboratory, manufacturing process, equipment, or facility