Download 21 CFR Part 11: Complete Guide to International Computer by Orlando López PDF

By Orlando López

Protecting regulatory standards stipulated via the FDA, this booklet delineates the association, making plans, verification, and documentation actions and procedural controls required for compliance with world wide computers validation rules. the writer introduces helping applied sciences equivalent to encryption and electronic signatures and locations regulatory compliance in the context of caliber insurance. He demonstrates the significance of integrating validation actions into the method lifecycle utilizing a established top-down process. He covers useful purposes of caliber coverage and engineering suggestions as they relate to the advance of structures healthy to fulfill consumer and regulatory standards.

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Extra info for 21 CFR Part 11: Complete Guide to International Computer Validation Compliance for the Pharmaceutical Industry

Example text

According to this CPG, computers I/Os must be tested for data accuracy as part of the computer system qualification and, after the qualification, as part of the computer system’s ongoing verification program.  In order to detect errors before a computer system makes decisions using tainted data, an on­going monitoring program needs to be established and followed to verify hardware and software I/Os during the operation of the system.  The level and frequency of the I/O verifications must be guided by written procedure, and based on the complexity and reliability of the computer system.

The Validation Project Coordinator will act as a consultant and must be familiar with the contents of the validation practices and procedures; and must have participated in appropriate training activities in the area of computerized systems validation.  For a large project, the validation coordinator role may require the assignment of a full­time person.  Although the developers and usersof the system may generate most of the SLC products, a qualified third party should review thecomputer systems validation records and give objective assurance to management that thecomputer systems validation was properly carried out.

Of those software related recalls, 192 (or 79%) were caused by software defects introduced when changes were made to the software, after its initial production and distribution. The maintenance activities must be governed by the same procedures followed during the Development Period. Chapter 18 provides information on ongoing support systems.  It is the responsibility of Executive Management to provide adequate resources to support the achievement of compliance in the computer systems validation area.

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