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Designate equipment as cGMP by selecting cGMP on the Record view page of the Equipment form (OMOBJC). |
Configure electronic records and signatures for work performed on cGMP equipment. Current Good Manufacturing Practices (cGMP) are a set of standards established by the United States Food and Drug Administration (FDA) to regulate the manufacturing processes of the food, pharmaceutical, and medical equipment manufacturing industries. cGMP identify the standard for safety and quality in manufacturing equipment, methods, facilities, processing practices, packing, and/or storage related to production and manufacturing.
Most companies that manage their maintenance processes on their equipment using Datastream 7i have a combination of equipment that is regulated by cGMP standards as well as equipment that is not regulated by cGMP standards. For companies using both cGMP and non-cGMP equipment who wish to utilize the electronic record and signature feature to ensure compliance with cGMP regulations, Datastream 7i enables you to configure electronic records and signatures for the EVNT entity to only take a snapshot of a record or require an electronic signature for work performed on cGMP equipment without having to undertake the administrative effort required for tracking electronic records and signatures for non-cGMP equipment.
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Designate equipment as cGMP by selecting cGMP on the Record view page of the Equipment form (OMOBJC). |
To configure electronic records and/or signatures for cGMP equipment, you must set the CGMPONLY installation parameter to ON. You must also define the electronic records/signatures for the EVNT entity on the Electronic record setup form (BNEREC).
If CGMPONLY is set to ON and you have configured electronic records/signatures for the EVNT entity, Datastream 7i will create an electronic record and/or require an electronic signature for work orders created/generated for cGMP equipment. No electronic records/signatures are created or required for work on non-cGMP equipment.
Likewise, if you have created a PM route that is associated with a work order containing cGMP equipment, Datastream 7i also creates an electronic record and/or requires an electronic signature for the work order associated with the cGMP equipment in the PM route. However, Datastream 7i does not create a separate electronic record or require an electronic signature for each child work order on the PM route. Only status changes for the parent work order generate an electronic record and/or require an electronic signature.
The electronic signatures for cGMP equipment configuration applies to work orders created/generated for cGMP equipment using the following forms:
Work orders form (WMJOBS).
Quick work orders form (WMVITE).
Rapid work order/request entry form (WMFLOG).
Work requests form (WMWREQ).
Print work order cards forms (WRJOBF), (WRJOBN), and (WRJOBB).
Release selected work orders (WNRELJ).
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The cGMP configuration also applies to work orders created using the object insert and update API for data collection. |
