Whether you are in the early stages of managing responses to FDA 483 observations, delivering on commitments to FDA as part of a Warning Letter or Consent Decree or, you have successfully satisfied FDA and you are in the end stages of returning to a new state of normal operations, you can never go back. You must maintain your Laboratory support in a state of current good manufacturing practice (cGMP) compliance at all times.
Examples of areas in which Regulatory Compliance Associates® Inc. can provide laboratory consulting support include:
- On-site inspections, i.e., Gap Assessment, General GMP, FDA Readiness, etc.
- Data Integrity Verification, i.e., OOS, OOT, Notebook Audit, Forensic Evaluation, etc.
- Calibration / Metrology Program Assessment
- Method Development and Validation Assessment
- Stability Study Program Assessment
- WFI Process Verification
- Risk Assessment for Modifications to Existing Labs or Build Out of New Labs
RCA laboratory compliance services include:
- ALCOA+ data integrity programs
- Analytical instrument qualification (AIQ)
- Chromatography data system (CDS)
- Custom validation services
- Computer system validation (CSV)
- Custom procedure writing
- Cyber-security software protection
- Equipment qualification plans (EQPs)
- Equipment qualification reports (EQRs)
- Instrument and software qualifications (IQOQ, OQ ,and RQ)
- IVD Test Implementation
- Qualification electronic traceability
Regulatory Compliance Associates® Inc. (RCA) provides worldwide services to the following industries for resolution of compliance and regulatory challenges:
We understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of FDA-and globally-regulated companies.