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Computer Systems Validation
Procedures
  • Corporate CSV Guidelines
  • Change Control—Project, Configuration
  • Periodic Review of Computerized Systems

CSV Assessments, Audits, and Inventory
  • CSV Systems Compliance Audit
  • CSV Systems Inventory—Equipment, Instruments,
  • Part 11 Assessments and Part 11 Systems Inventory
  • Compliance Assessments - Security, System Data Storage, Backup and Recovery, etc.

Software Development Life Cycle
  • Validation Master Plan
  • Vendor Audits
  • User Requirements Specification (URS)
  • Functional Requirements Spec. (FRS)
  • Technical Design Specification (TDS)
  • Requirements Traceability Matrix (RTM)
  • Source Code Review
  • System Startup & Commissioning
  • Installation Qualification
  • Operational Qualification
  • System Summary Report
  • Periodic Review

Qualification & Developing Test Methods
a.    Computerized Systems
-System Test Plan
-Installation and Operational Qualification
-I/O Testing, Loop Testing, Proportional Integral Derivative (PID) Testing
-Functional Testing, Backup Data storage Verification, Alarms
-Screen Graphics and Data Verification, Calculations Verifications
-System Remediation & Deviation Resolutions
-Review of Test Data and Final Reports
b.    Software
-Application Software Qualification
-Code Reviews, Modular System Integration Testing
-User Interface Testing, Password and Security Verification

Computerized Systems Validation

Companies are confused about "how much is enough" in computer validation work. Many firms are losing valuable time and productivity as system teams try to figure out how to proceed in validation work. A standards-based approach is needed for CSV work to become a normal part of business in regulated environments, and our Compliance Group has different systems ready for implementation depending on your specific needs.

We have on staff professionals in systems design, validation and Part 11 with Compliance Managers to assist you with equipment, packaging lines, PLC’s, SCADA’s, BAS, LIMS, MRP, and SAP systems.  Some areas in which we can provide support are listed below:
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