GxP and Medical Device Compliance Services

Commissioning, Qualification
and Validation Services

We provide our clients with GxP and GMP services including auditing, inspection preparation, Raw Data Handling, Inspection remediation and QA support

 

Commissioning, Qualification, and Validation

At Consultys, our goal is to help clients ensure their facility, utilities, and equipment perform as intended. We do that through commissioning and qualification services, using a risk-based approach to maximize time and cost efficiencies through focused qualification efforts.

Our experienced Consultys team has the technical skills and experience to make our clients' projects successful. By using current industry trends and methods to help define and implement best practices, we quickly adapt to the needs of each individual client, knowing each project has unique requirements.

Qualification and Validation Services

Consultys validation services is supported by the fact that Consultys is a employer of well trained Validation Scientists and Engineers and can offer Validation Consultants and/or Validation Contractors to support you throughout the validation life cycle projects. They will use a risk-based approach to focus scarce resources only what needs to be validated to ensure product quality and patient safety.

 
Technical File and Design of Medical Devices

Validation Services

  • Manufacturing Process Validation (PV): Bio, Vaccines, Pharma, Med Devices, Consumer Products
  • Packaging Process Validation (Pkg V)
  • Cleaning Validation (CV)
  • New Approaches to Cleaning Validation
  • Analytical Methods Validation & Transfer
  • Software Validation and CSV 21 CFR Part 11
  • Network / IT Infrastructure Validation
  • Risk Based C&Q, Cleaning and Process Validation
  • Validation Master Plans
  • Maintenance of Validated Status: Verification vs. Validation? We apply QRM most recent approaches Revalidation
Technical File and Design of Medical Devices

Commissioning (C) & Qualification (Q)

  • Green Building Commissioning
  • Manufacturing and Packaging Equipment Qualification (IQ,OQ,PQ)
  • Design Qualification (DQ)
  • Maintenance System Qualification
  • Utilities Qualification
  • Facilities Qualification
  • FAT / SAT
  • Risk Assessment and Risk Management: Direct vs. Non-Direct Impact; Critical Vs. Non-Critical
  • Commissioning and Enhanced Commissioning
  • Decommissioning
  • Integrated Validation Approach
  • Suppliers / Materials
Medical Device Risk Management ISO14971

Risk-Based Approach for Qualification

  • Interpretation and Application of Quality Risk Management Guidelines (ASTM, ISO)
  • Leverage testing from Commissioning (Enhanced Commissioning)
  • Eliminate redundant paperwork during qualification
  • Reduce test cases based on risk assessments
  • Interpretation and Application of new standards based on Risk Based Approach
  • Streamline practices and procedures
  • Develop risk management exercises (e.g., FMEA)
  • Consultys can conduct on-site supplier audits on your behalf to ensure that their manufacturing activities are being executed according to your specifications and the applicable regulations.
 

Contact our Qualification & Validation Experts

Please contact us to learn more about our Comissioning, Qualification and Validation services.