Learn more about Compliance Teams 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 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 aspects 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 (and control systems) are subject to more regulatory scrutiny for compliance to current regulatory expectations given the greater importance and complexity (i.e., higher risk) of computer and control systems used by manufacturers in assuring the quality of manufactured products. The Good Automated Manufacturing Practice (GAMP) Guide for Validation of Automated System presents an approach for industry professionals internationally to use for implementing validated and compliant automated systems meeting regulatory expectations. The GAMP guideline defines a set of principles, practices, and documents that form a consistent approach for professionals involved in engineering and validation of these systems to follow.
The set of 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
How can Compliance Team help with computer system validation?
Compliance Team’s consultants are experienced with executing software and computer system validation projects. We have developed a streamlined ASTM E2500 approach 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.
Compliance Team’s subject matter experts understand that the level of validation required for each computer system should be based on the unique risk and impact the system may have on patient safety, product quality, and data integrity. No matter the system’s level of complexity, a key objective of Computer System Validation remains clear…to ensure that the system functions as expected to satisfy specific user requirements, based on risk and the user’s “intended use” of the computer system.
Our expertise and project execution processes help ensure that our clients’ computer system is fully qualified through a structured approach consistent with the recommended practices established in the ISPE Good Automated Manufacturing Practice (GAMP5) guidance.
Compliance Team has developed procedures, processes, and templates needed for Computer System Validation to simplify and control the cost of validation while delivering the compliance and regulatory outcomes our clients require. How can we help you? Click below to learn more.