|
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
|
|
|
|
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. |
|
