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Validation Templates

  • Validation Templates:
  • Silver Package:
  • Gold Package:
  • Platinum Package:
  • Add-ons:
  • Contact Sales:
CCS provides ready-to-use Validation Procedures, Templates and Forms.

Each package includes additional integration and support services. Templates, forms and documents will be provided in MS Word / MS Excel format, as download versions or during integration workshops on site.

You can choose them in German or English language, additional language packages are available on request.
Silver Package incl. Integration Workshop:

• Validation Plan• User Requirement Specification• Risk Assessment (FMEA)• Test Plans IQ / OQ / PQ• Test Protocols & Scripts IQ / OQ / PQ• Test Reports IQ / OQ / PQ• Validation Report
Gold Package incl. Integration Workshop and Support:

• SOP Computer System Validation• High Level Risk Assessment Form• Validation Plan• Quality Project Plan• User Requirement Specification• SOP Risk Management• Risk Plan, Assessment (FMEA), and Report• Supplier Audit Checklist, Audit Report• SOP Testing & Reporting• Test Plans IQ / OQ / PQ• Test Protocols & Scripts IQ / OQ / PQ• Test Reports IQ / OQ / PQ• 21 CFR Part 11 Assessment Form (ER/ES) • Validation Report
Platinum Package incl. Integration Workshop, Support, and Training Sessions:

• SOP Computer System Validation• SOP IT Infrastructure Qualification• High Level Risk Assessment Form• Validation Master Plan• Inventory List (Applications & IT Infrastructure components)• Validation Plan• Quality Project Plan• SOP IT Project Management• User Requirement Specification• SOP Risk Management• Risk Plan, Assessment (FMEA), and Report• Supplier Audit Checklist, Audit Report• Template Quality Agreements / Contract Reviews• Functional Specification• HW and SW Design Specifications• SOP Software Development• Unit and Integration Testing Forms incl. Source Code Review• SOP Testing & Reporting• Test Plans IQ / OQ / PQ• Test Protocols & Scripts IQ / OQ / PQ• Test Reports IQ / OQ / PQ• 21 CFR Part 11 Assessment Form (ER/ES)• System Descriptions • Validation Report• Handover documentation• SOP Backup & Recovery, Access Mgt., Disaster Recovery, Contingency Planning, Issue Management)

Online library for all relevant CSV regulations incl. update service for 3 years
Add-Ons (optionally):

• Validation of Spreadsheets (e.g. MS Excel)• Validation and Qualification of SCADA / PLC Systems• Validation of ERP Systems• Validation of DMS Systems• Strategy Paper for Medical Devices• Compliance Package GCP (CROs)• Compliance Package GDP• Qualification of Cloud Solutions• CSV Glossary (including update services)• Validation Concept for Electronic Batch Recording and/or Paperless Lab• Retrospective Validation Strategy (incl. History Report, Risk Assessment, CAPA Plan)• GAP Assessments (e.g. Annex 11, Part 11)• Compliance Checklist (incl. GAMP 5)• Inspection Readiness Package (PowerPoint)• Product White Papers (for Suppliers / Vendors)• SOP Test Automation and Issue Management
ISPE GAMP 5 certificate:• according ISPE GAMP 5 - Form # 17 and Validation Planning (Appendix M1)

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We can also help you to select the right packages for you and how to implement procedures and processes efficiently.