Laboratory supportWhether 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

 

About RCA

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.

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