cGMP Validation, LLC

Additional Services Provided
          Educational Training
                     Programs

cGMP Validation offers on-site training for your staff.  Common topics include validation protocol generation and execution, FDA pre and post approval inspections, QA / QC protocol development and Part 11 compliance.  cGMP Validation also can develop a custom training program for your company's internal training procedures.
                  Auditing and
         Risk Assessment Services

cGMP Validation offers supplier / vendor audits, contract laboratory audits and compliance auditing.  Audits are tailored to meet the specific needs of your company.

We also offer a Risk Assessment Service, based on a numerical rating system. 

         Regulatory Consulting 
                       Services
cGMP Validation helps companies develop and implement sound GMP compliance strategies.  cGMP Validation can assist your company with FDA pre and post approach inspections, QA / QC documentation review, regulatory interpretation and submissions.
                 Commissioning
                        Services
During commissioning and start-up of a new facility, documentation is critical to the validation effort should be complied and organized.  Poor commissioning negatively impacts the validation effort and can result in persistent compliance problems.  cGMP Validation assists in many activities related to commissioning and start-up of new facility such as preparation of specifications and engineering turn over packages (ETOPs).
Computer Validation Services

 

cGMP Validation has led computer validation projects related to:

  • Computerized Systems Validation support documentation development
  • Computerized Systems Guidelines Development
  • Computerized Systems Configuration
  • Automation / Controls Systems Validation for temperature, humidity, access control etc.
  • Laboratory Management Systems (LIMS) for Beckman and Waters Millennium
  • Building Management Systems (BMS)
  • Supervisory Control and Data Acquisition Systems (SCADA)
  • Programmable Logic Computers (PLC)
  • Software QA / QC
  • Data Migration Plan development
  • Bar code, material handling, vision inspection, and process monitoring systems
  • GMP / GAMP Compliance Assessment and Remediation Planning


21 CFR Part 11

21 CFR Part 11, FDA's requirement for the use of electronic records and electronic signatures, continues to be a challenging compliance issue for regulated industry.  Validation can help you understand and implement a risk-based approach rooted in Final Guidance for Scope and Application.  From initial gap-analyses and remediation planning for existing systems, to prospective assessments of new systems, our experience will help you determine the Part 11 relevance and associated requirements for compliance.