ISPE Good Practice Guide: Management Engineering Standards PDF

The ISPE Good Practice Guide on the Management of Engineering Standards aims to provide a common understanding and approach to the management of Engineering Standards. It is based on industry best practices and developed with input from several peer organizations. The Guide addresses the knowledge management needs associated with the identification of content, creation, review, and approval of Engineering Standards.

The ISPE Good Practice Guide: Management of Engineering Standards provides guidance on how to establish and maintain an Engineering Standards Program.It covers the entire lifecycle of an Engineering Standard, from chartering to retirement. In addition, it includes a description of the governance process for the Engineering Standards Program.

Several templates and examples are provided separately in MS Word for use by readers within their organizations.

This Guide is a unique opportunity to consolidate, into a single document, the complex body of knowledge involved with Engineering Standards in the highly regulated pharmaceutical industry. It is intended for established engineering standards program, or if you are looking to change or develop one. In addition, this Guide addresses the process of keeping content current and compliant through periodic review and successful integration with third party designers/integrators.

Key benefits of having an Engineering Standards Program include:

• Streamlining of the engineering information gathering processes by providing a compliance roadmap for engineers to follow
• Providing an effective knowledge capture and dissemination process (Knowledge Management System) that is integrated into the engineering process
• Assuring the appropriate level of quality, safety, and regulatory compliance is incorporated into engineering designs
• Reducing costs and time to conceptualize, engineer, specify, design, commission, and qualify engineering solutions

The ISPE Good Practice Guide on the Management of Engineering Standards is written for engineering standards programs, but the principles also apply to other guidance documents including ISPE Guidance Documents, International Council for Harmonisation (ICH) guidelines, and industry recognized standards.