Lab testingWhether 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 ISO 17025 compliance and Lab testing support in a state of current good manufacturing practice (cGMP) at all times.

 

Regulatory Compliance Associates® Inc., in partnership with Nelson Labs, can provide lab testing and consulting support:

 

  • 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
  • ISO 17025 Compliance Audit
  • ISO 17025 Mock Inspection
  • ISO 17025 Training & Development
  • WFI Process Verification
  • Risk Assessment for Modifications to Existing Labs or Build Out of New Labs

 

RCA validation testing services

Facility & Process validation

  • Cleanroom Validation
    • Installation Qualification  
    • Operational Qualification 
    • Performance Qualification
  • Water System Validation
    • Sampling
    • Microbiological Testing
    • Alert and Action Limits
  • Process Validation
    •  RMM
    • Surfaces
  • Sterilization Validation
    • ISO 11135 (ethylene oxide)
    • ISO 11137 (radiation sterilization)
  • Re-Use Validation
    • Device reprocessing
    • Cleaning
    • Disinfection
    • Sterilization
  • Packaging Validation
    • ISO 11607-1:2019
      • Requirements for materials
      • Sterile barrier systems
      • Packaging systems
    • ISO 11607-2:2019 
      • Validation requirements
      • Forming
      • Sealing

Biological evaluation testing

  • Biological Evaluation Plan
  • In Vitro Biocompatibility
    • Cytotoxicity testing
    • Hemocompatibility testing
    • Genotoxicity testing
  • In Vivo Biocompatibility
    • Implantation testing
    • Irritation testing
    • Thrombogenicity testing
    • Sensitization testing
    • Systemic Toxicity testing
    • Genotoxicity
  • Chemical Characterization (E&L)
    • Gas Chromatography/Mass Spectrometry
    • Liquid Chromatography/Mass Spectrometry
    • LC Chromatogram
    • Inductively Coupled Plasma
  • Toxicology Assessment
    • Hazard identification
    • Data evaluation
    • Exposure assessment
    • Dose-response analysis
    • Risk characterization

 

 

Sterilization validation testing services

Radiation validation testing

  • Product Sterility
    • Product shelf life
    • Stability and/or package integrity
  • Verification Dosing
    • Maximum Dose
    • Dose Mapping
  • Bioburden
    • Test Method Validation
  • Bacteriostasis/Fungistasis
    • Microbial contamination
    • Method suitability 
    • Method validation
  • BET/Particulates

EO validation testing

  • BI Sterility
    • Steam Sterilization (Autoclaves)
    • Vaporized Hydrogen Peroxide Sterilization
  • Product Sterility
  • Bioburden
  • EO Residuals
  • BET/Particulates
  • PCD’s

Re-Use validation testing

  • Cleaning
  • Disinfection
  • Sterilization
  • Clinical Monitoring
  • Simulated Use
  • Lifecycle Testing

Packaging validation testing

  • Aging (real-time)
  • Aging (accelerated)
  • Strength and Integrity
  • Distribution Studies
  • Thermal & RH Cycling
  • Stability Testing

 

Additional testing services

  • Sterility Assurance Testing
  • QDA (Radiation)
  • Product Sterility
  • Verification Dosing
  • Bioburden
  • BET/Particulates

 

Sterility assurance testing

  • QDA (Radiation)
    • Product Sterility
    • Verification Dosing
    • Bioburden
    • BET/Particles
  • ED Lot Release
    • BI Sterility
    • EO Residuals
    • BET/Particulates
    • PCD’s
  • Other Sterility Assurance
    • Bioburden
    • Organism ID’s
    • Cytotoxicity

 

RCA lab compliance services

  • 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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