Gamp software category 2

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Skip to content. Risk Value Level Category Definition Examples Low Application Category 1 — Infrastructure Software This includes operating systems, database managers, programming languages, middleware, ladder logic interpreters, statistical programming tools, and spreadsheet packages but not applications developed using these packages.

Option 2. Option 3. Search this website. Read More ». Related Articles. Subscribe to get validation news and free tips by email. Category 1. Not applicable. Category 2. Category 3A. Not preferred. Category 3B. Category 3C. Category 3D. Category 3E. Category 4. Category 5. The regulators mandate that all good automated manufacturing processes and methods used to produce a regulated product must be documented and be company approved. The original SOP once approved will reside in a safe and secure location in change control this is a regularly audited requirement.

It really depends on your company practices and procedure which also must be documented and approved as to whether the GAMP 5 doctrine is in electronic format with; or without, e signatures. Security of this document is initially by physical access and then by a series of cascading passwords.

The cascade must ensure that the person accessing the document can only access the document to the level that the company has authorized. Continuous control of all issued copies must be maintained by change control.

Change control must at all times another regularly audited point know the location of all the SOP copies in circulation and must have the capability to be able to recall them for incorporation of amendments or destruction. As an auditor, I have audited for these features for many years and I have never found a case of un-authorized SOP changes.

This always puzzles me; why shoot yourself in the foot over something so obvious, but a glance through the warning letters shows this is still one of the major causes of FDA citations. GAMP 5. Repository: Montreal.

Queries: info validation-online. It has been carefully designed to make it the preferred choice for Process and Laboratory stand alone equipment.