Computer validation – CEFIC – Free PDF download




In the last decade, computerised systems have become a vital part in the manufacture of Active Pharmaceutical Ingredients.
Typical applications are Process Control Systems (DCS, PLC, SCADA) ,Laboratory  Information Management Systems (LIMS), Laboratory Instrument Control Systems and Business Systems (ERP, MRP II).
cGMP regulations imply that the functionality’s those computerised systems, which have influence on the quality of the API, should be validated.
Validation shall demonstrate that the parameters defined as critical for its operation and maintenance are properly (adequately) controlled/managed.
It is essential that the validation is practical and achievable, adds value to the project, and is concentrated on the critical elements of the system.
This Guideline outlines the scope and legal requirements for the validation of computerised systems, chapters 7 to 9 give a comprehensive methodology suitable for most situations within API production control and data handling situations.
For some specific cases the coverage may be less extensive and/or subsections may be merged depending on the criticality and the importance of the systems to be validated.
Where specialist validation cases are to be handled paragraph 10 gives the official guidance, references and industry guidelines.

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