Validation Templates

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)

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