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Computer System Validation Services
The importance of having validated computer systems (i.e., automated
systems, process control systems, manufacturing executing systems,
laboratory information management systems, document management
systems, IT systems, etc.) for helping today’s pharmaceutical
companies manage and control their mission critical operations and
manufacturing processes is well understood and embraced by the
pharmaceutical industry.
The level of validation required for each system should be established
based on risk and the impact that a system may have on product
quality. Computer systems are validated to ensure that the critical
functional requirements of the system, as it pertains to the user’s
“intended use”, satisfy the user requirements (i.e., as defined in a
User Requirements Specification).
Computer systems are subject to more regulatory scrutiny for
compliance to current regulatory expectations than in the past given
the greater importance and complexity (i.e., higher risk) of the
systems used by manufacturers in assuring the quality of manufactured
products. The Good Automated Manufacturing Practice (GAMP) Guide for
Validation of Automated System (i.e., GAMP 4 issued in December 2001)
provides a good and easy to use framework for industry professionals
internationally to use as a standard to achieve validated and
compliant automated systems meeting regulatory expectations. GAMP 4
defines a set of principals and practices that form a consistent
approach for the pharmaceutical industry professionals involved in
engineering and validation of these systems to follow that is easily
understood by suppliers and regulators.
The qualification documents required to establish documented evidence
for compliance generally include the following documents:
• Validation Plan
• User Requirements Specification (URS)
• Functional Specification (FS)
• Design Specification (DS)
• Installation Qualification (IQ)
• Operational Qualification (OQ)
• Performance Qualification (PQ)
• Validation Summary Report
Compliance Team’s validation engineers are experienced with using the
practical GAMP 4 approach in executing software and computer system
validation projects. We have developed a streamlined approach
consistent with GAMP 4 and the associated procedures and templates to
simplify and to control the cost of computer system validation.
Whether your validation project is for a simple process control system
or a complex IT system implementation – we stand ready to support you
with our team of experienced qualified professionals.
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