Documents

GxP, 21CFR Part 11 (ERES), training, audits, safety, QC/QA, validations

List of Documents Available

• Validation Templates
  • IQ assessment and collection
  • Validation - general & part-11 equipment / instruments
    • Installation Qualification (IQ)
    • Operation Qualification (OQ)
    • Performance Qualification (PQ)
    • User Requirement Specs (URS)
    • Functional Requirement Specs (FRS)
    • Design / HW / SW Specs (DS)
    • Traceability Matrix
  • ERES - software / computerized Validations (Part 11)
  • Test Methods Validations
  • Cleaning Validations
  • Sterilizer / Sterilization Validations
  • Process Validations
  • Laboratory Instruments Validations
  • Facility Validations
• Validation Master Plan Template
• Standard Operating Procedures (SOP) - general
• Audit Templates
  • GMP
  • GLP
  • Vendor
  • GAP analysis
• Quality Manual
• Quality Control / Quality Assurance SOP's
• FAT / SAT protocols for common systems/equipment
• Calibration SOP's
• Maintenance / Cleaning / Interval services