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cGMP Validation

Computer Validation Services:
cGMP Validation's computer validation group consists of individuals with experience in both regulatory compliance and information technology. The computer validation group's experience spans a wide range of computerized systems and applications.
cGMP Validation has developed and successfully deployed an assessment tool for GMP determination and 21 CFR Part 11 Compliance for several clients. This methodology systematically evaluates both legacy and new computer systems to determine GMP and Part 11 compliance. A Remedial Action Plan is then developed and executed based on the gap analysis conducted for Part 11 compliance.

Computer Validation Experience:
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 Information Management Systems (LIMS) for Beckman and Waters Millennium
Building Management Systems (BMS)
Supervisory Control and Data Aquisition 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 requirements for the use of electronic records and electronic signatures, continues to be a challenging compliance issue for regulated industry. cGMP Validation can help you understand and implement a risk-based approach rooted in FDA's 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 associate requirements for compliance.

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