Proper functioning and performance of software and computer systems are critical in obtaining consistent, reliable and accurate data. Evolving technologies requires an increasing focus on network infrastructure, networked systems and on the security, authenticity and integrity of data acquired and evaluated by the computer system.

The computer validation life cycle typically consists of
  • User Requirement Specification (URS)
  • Functional Specification (FS)
  • Design Specification (DS)
  • Development and testing of code
  • Installation Qualification (IQ)
  • Operational Qualification (OQ)
  • Performance Qualification (PQ)
  • Retirement as described in a Validation Master Plan and completed Validation Report.
  • Configuration management and change control are also included.

Verta Life Sciences can offer the entire risk based validation process from writing specifications to installation and initial and on-going operation in a practical and defensible approach. This includes qualification of computer hardware with peripherals and accessories, validation of software loaded on a computer controlling equipment and/or capturing and processing raw data. Verta Life Sciences has extensive experience developing the documentation required by regulators in compliance with formal regulations and industry guidance such as FDA 21 CFR Part 11, Annex 11 for European GMP’s and GAMP Guidelines.

Computer System Validation – Case Study

Issue:

A leading national health care organization with a centralized lab service required their existing laboratory information system (LIS) to be FDA compliant including 21 CFR Part 11.

Objective:

Analyze SOPs and computer systems to create and execute a validation plan and mentor staff on compliance requirements and process.

Deliverable:
  • An analysis of lab SOPs and system technical information was conducted in collaboration with lab directors, lab managers and IT. The Validation Master Plan and a Project Plan was then developed and a cross departmental Project Team established. The plan was based on a retrospective validation approach and minimal documentation changes to meet compliance guidelines.
  • SOPs were drafted to execute the Validation Plan to meet compliance requirements as well as establishing the processes required to maintain the system in a validated state.
  • Project managed the successfully execution of the Validation Plan and trained staff in compliance requirements and related SOPs.
  • Provided document management and data management solutions.
  • Executed the Validation Plan which resulted in the following deliverables.
  • Qualification of production Servers.
  • Qualification of testing environment Server.
  • LIS Requirements Specification including 21 CFR Part 11 compliance.
  • LIS Design Specification.
  • LIS Installation Qualification to Testing Environment.
  • LIS Operational Qualification.
  • LIS Installation Qualification to Production Environment.
  • LIS Requirement Traceability Matrix.
  • LIS Validation Summary Report.