Validation 2.0 concepts
 

Validation 1.0 Basis:

Paper-based validation documents and processes:

  • Validation Plan(s), Validation Master Plan, Quality Plan
  • Specification Documents (from process based to technical) like URS, FS, TS, DS
  • Test Plans, Specifications, Reports  (Unit, Integration Test, System Test, FAT, UAT, PQ)l
  • Executed Test Scripts, Reports and screen shots
  • Traceability Matrix, Conclusion
  • Error Forms

Validation 1.0 Summary:

  • Expensive and inflexible
  • Tedious and nontransparent
  • Time-consuming: efforts vs. quality improvements

 

Validation 2.0 Vision and Mission:

An electronic system package that manages each of the deliverables for validation, streamlining review and approval processes, reducing time and cost to comply with regulatory requirements, and securing quality improvements and good engineering practices and standards (ASTM E2500, CMMI, etc.). 

 

Validation 2.0 Implementation:

Several Document Management, Workflow Management, and Application Lifecycle Management systems seem like an obvious fit for the Validation 2.0 vision. We at comes compliance services encourage this Validation 2.0 approach with different sets of tools and services, from pre-qualified open source solutions to widely used and commercial applications. We are using these set up for professional IT project and validation management, support, software development and delivery, release management, and document management.

 

Contact us today if you want to find out more about Validation 2.0, including our free demo systems implementations, hosting services, and ongoing support. Choose following options:

  1. Commercial Package: HP Quality Center (more info)
  2. Open-source Package: Xstudio - Validation Tools for Requirements, Project, and Test Management (online demo)
  3. Open CCS validation model.  

 

Special Validation Interests (SVI):

 

  • Data Migration Validation (Data Mapping & Transformation) and Interface Validation
  • Cutover and Backout / Rollback Plans
  • Mapping Computer System Validation to ITIL®V3 and COBIT®4.0
  • MS Excel / Access Validation
  • RACI Traceability: Roles and Responsibilities (Responsible, Accountable, Consulted, Informed)
  • Keep it validated: “Trigger and Checks” during system operation
  • Hand-over process: Patch and Release Management
  • IT Change Control and CAPA Management
  • Emergency Change, Repair Activity, and Incident / Problem Management
  • Business Continuity Plans (BCP) and concepts
  • Security Management: Baseline concept, IT policy
  • IT compliance for New Starters, Leavers, and Movers
  • Records Management, System Retirement

 

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We are always eager to share our passion for quality!

 

 

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