Home

Links

Contents

Company

Documents

Services

Contact Us

SAFETY
AUDITS
TRAINING
QUALITY ASSURANCE
QUALITY ENGINEERING
FREE DOCUMENTS
VALIDATION SERVICES
CAREERS
CONTACT US
Google
Search www.qualityleader.com

Documents

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

Go to Document Index Download

 

Providing Quality & Validation Services for the Pharmaceutical, Medical Devices, Biotech and other industries within North America, Europe, Asia, Australia, and other areas of the world.

More Details.

Providing validation and compliance services that meet your schedule and budget.


More Details.

Stay current with regulations and industry demand. We create affordable deliverables and provide validation and QE services that stand up to the FDA inspections.

More Details.

 

Home | Company | Services | Links | Contents | Documents | Contact Us

CL Tech Inc. © 2009