21 CFR Part 11 Compliance Testing & Validation Services

With extensive experience in helping top organizations implement a broad range of software validation and verification based on 21 CFR part 11 Compliance testing, Indium offers solutions for compliance assessment, testing covering functionality and performance aspects, devising strategy and process and maintenance hence covering all the key facets of software lifecycle.

Indium Software’s testing solution for 21 CFR part 11 Compliance testing and Software Validation includes

  • Developing a software validation framework
  • Performing independent evaluation & assessment
  • Implementing validation strategy, templates, checklists and operating procedures and developing essential validation deliverables
  • Integrating quality processes and compliance tasks
  • Solution mapping to various compliance parameters
  • Delivering computer system validation audit report and metrics dashboard – 21 CFR Part 11 Compliance % and qualification protocol coverage
  • Providing extensive documentation and process improvement reports & templates
  • Training Information Technology users on compliance regulations

Why Choose Us?

  • 99.9% assured success in computer system validation Audit
  • Proven experience of working with leading Lifesciences firms
  • Leverage jump start kits (Template, Guidelines, Checklists, reports) to address immediate requirements

Indium Software’s System Specific Expertise

Process Controls
Fraud Detection
Audit Trails
Records Retentions Support
Access Control
Export of Agency Review
Electronic Signatures
Open Systems Controls

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