Validation (GAMP, FDA,...) and S88 Standards for Batch and Recipe Management Systems - INTERKAMA 1999

About

Starting from GAMP and FDA validation rules for software systems in a manufacturing environment, the equivalence between these rules and the S88 standards is explained. Advantages like having a unique framework for specifications and description of the system and ways to produce (recipes) is obvious and straightforward.

Additional advantages in controlling and documenting the IT-project lifecycle inclusive the use of prototyping (GAMP-3) and the use of standard objects offer additional increases in
efficiency and shorter implementation delays. Using the S88 (and SP95) leads towards an actualised methodology for software design and implementation and provides the necessary
tools and records for better project control. Change management during design, implementation, commissioning and production is better under control and side effects can be simulated.

As an example a validation checklist for S88 is presented which could be used as a framework for other projects. Casematerial of some biopharmaceutical production sites (and S88 promoters) will clarify this by stepping through their development and validation cycle and provide some metrics to underline this viewpoint.

- Downloadable files require Adobe Acrobat Reader.

Customers who bought this product also bought: Possible Recipe Procedure Presentation Formats (Downloadable) Batch Control Part 2: Data Structures and Guidelines for Languages (Downloadable) Applying S88: Batch Control from a User's Perspective S88.01 Concepts Streamline Control Software Application for Biotech Plant - ISA TECH 1997 Defining the Interface Between ERP, MES, and the Control Systems - ISA EXPO 1998