Standard Operation Procedures (SOP)
Standard Operation Procedures (SOP) describes how to use and maintain the system and equipment during regular operation. cGMP requires SOPs to be in place for systems and equipment used in a regulated environment.
In pharmaceutical production all important operations associated with a computer controlled system must be performed according to written operating procedures. Such operating procedures are intended for "standard" operation of the system and are accordingly called Standard Operating Procedures.
SOPs are not batch or product specific, but describe how a specific operation related to the computer or process system must be performed. SOPs must be written and approved in accordance with cGMP and updated whenever relevant. The adequacy and accuracy of the SOPs used must be re-evaluated periodically.
Fast Trak Validation™ currently offers SOPs for all relevant functions in a computer-controlled UNICORN™ system, e.g. backups, revalidations and log book. The SOPs are offered in sets of related documents as hard copy or in Microsoft Word versions. The electronic copy can be used to modify or to customize the template SOPs. The benefits of using these template SOPs are shorter implementation time, reduced development costs, fewer regulatory setbacks, and more time released for your personnel. The SOPs are currently available in English only.
Fast Trak Validation™ can also offer help to write and develop SOPs for processes related to GE Healthcare systems and columns.
Contact your local GE Healthcare Sales Representative for more details.
Read more in Standard Operating Procedures (SOPs) for UNICORN Controlled Systems and Related Equipment data file
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