Computer System Validation

I bought this software off the shelf and it claims to be 21 CFR compliant.  Why do I still need to validate my system?

This is a great question, and one that comes up so frequently.  Computer System Validation (CSV) is the process of providing documented evidence that a computer system performs exactly as intended, in a consistent and reproducible manner.  More specifically, 21 CFR part 11 is a regulatory requirement that all systems that govern any cGXP process, should be validated.  Just because the the software boasts compliance,  it doesn’t guarantee that the software you purchased and installed will perform exactly as intended in your real working environment.  You will never know until you test and verify the system against the predetermined requirements.  Meeting these requirements can be very costly if not approached the correct way.  QACV Consulting can help your organization tackle the validation process with confidence and eliminate unnecessary expenditures.  Our validation services can range from a full and complete system review and implementation to basic compliance assistance and consulting.  Bottom line, we customize your validation project to meet your existing needs and budget limitations.  Our CSV Consultants specialize in GAMP5, FDA 21 CFR Part 11 and PIC/S annex 11.  QACV Consulting can help your company meet these regulatory requirements and industry standards.

What you can expect from QACV Consulting

Our CSV compliance specialists use a systematic and risk-based approach to evaluate your processes to satisfy regulatory requirements.  The end result of your CSV project will be:

  • GMP, GLP or GCP compliant IT systems and processes
  • Sustainable process for continued validation and compliance
  • Increased internal and external security
  • 21 CFR compliance
  • Valuable skills learned that transfer to future validation projects, saving you time and money in the long term
  • Preparedness for internal and external audits

Development and Implementation of Computer Systems Compliance
and Computer Systems Validation Support

Our CSV services can assess any of the following items or all of these, depending on your organizations goals:

  • Audit preparation
  • Validation strategy or plan
  • Functional Requirements
  • System Design Specifications
  • Test Plan (IQ, OQ, PQ)
  • User Requirements Specification
  • Qualification/Testing Protocols
  • Clearly defined Software Development Lifecycle (SDLC)
  • Risk assessment
  • Standard Operating Procedures (SOPs)
  • Software testing and verification
  • Personnel qualifications and/or training
  • 21 CFR part 11 Gap Analysis and Remediation Planning
  • Annex 11
  • GAMP5
  • cGXP industry standards
  • System Documentation
  • Validation reporting
  • Change control and Configuration Management Implementation
  • Data migration
  • User documentation
  • Installation and management
  • Electronic security
  • Physical security
  • Archiving
  • Backup and disaster recovery
  • Facilities management