Teams of Integrated Commissioning & Qualification Corporation (ICQ) Consultants have played a central role in the development, implementation and execution of various quality by design systems as well as the commissioning and qualification of multiple manufacturing plants in the New England area and elsewhere, including some of the world’s largest biotechnology facilities. Now due to increasing demand for ICQ services and recent growth ICQ Consultants is expanding the services within the computer system validation (CSV) industry demand:
Overview: Title 21 CFR Part 11 requires; “Validation of systems to ensure accuracy, reliability, consistent intended performance, and the ability to discern invalid or altered records.” With that said, Validation is confirmation by examination and provision of objective (documented) evidence that computer systems conform to user needs and intended uses, requirements are consistently fulfilled, and applicable regulatory requirements (such as 21 CFR Part 203, 21 CFR Part 820, etc.).
Validation, at its most basic level, is the process of ensuring that applications, systems, and/or environments satisfy intended functionality in a consistent and reliable manner. Primarily, validation is accomplished via software testing – the process of executing a predefined sequence of steps, emulating typical user scenarios and data, to determine if the application, system, and/or environment under evaluation performs as intended. Validation includes verifying:
- Requirements of the system are met (both regulatory and business)
- System performance (speed and accessibility) is acceptable
- Data integrity is properly maintained (not lost, improperly modified, etc.)
The primary benefit of validation is a level of assurance that the system will perform as required and intended during operation. A validated system should be more cost effective to maintain, yield greater Return on Investment (ROI), and result in reduced risk of data loss and issues with regulatory requirements.
ICQ Consultants provides a broad range of Computer System Validation (CSV) services in support of clients’ manufacturing, laboratory, and enterprise systems. We bring a full understanding of pharmaceutical, biotechnology, and medical device business processes to a practical risk-based approach to computer system validation. And, by verifying the controlled development and implementation of computer systems, we ensure the integrity, reliability, and availability of their regulated business data to support the production of quality products and protect patient safety.
The following are a few key components of services provided:
- Validation methodology based on GAMP5 guidelines and risk-management practices
- Validation plan
- System risk assessment report
- User requirements specification
- System configuration specification
- Test plan
- Installation Qualification (IQ)
- Operation Qualification (OQ)
- Performance Qualification (PQ)
- Assessment for compliance with regulations pertaining to electronic records and signatures (e.g., 21 CFR Part 11)
- Validation traceability matrix
- Quality assurance review
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Written By: Alfonso Guarracino, Senior Director of Information Technology
ICQ Consultants Corp.