In the regulated life sciences environment, the management of controlled documents such as SOPs (Standard Operating Procedures), procedural instructions or work instructions is of great importance. Change management processes ensure that these documents are properly revised, approved, trained, distributed and, where necessary, suspended. In addition to well-known use cases within change management, there are special cases that are handled differently from company to company.
One of these applications is the rare case of so called Temporary Document Change (TDC).
A precision balance for laboratory use requires precise work instructions in order to avoid incorrect operation by laboratory personnel. Due to a device defect, a replacement device is used temporarily. The replacement device requires a similar work instruction as the original device, but there are small differences in handling. The document coordinator responsible for the work instruction initiates a TDC process in the company’s own electronic document management system (DMS):
- In a first step, a copy of the original instruction is created. A trained technical author extends this document copy by the steps necessary to properly operate the replacement device. At the same time, the document coordinator submits achange request) to the responsible quality assurance department, explaining why it is necessary to temporarily replace the laboratory device and thus to reformulate the operating instructions.
- After approval by the quality assurance department, the document coordinator can then approve the temporary work instruction, which the technical author has completed, by the quality assurance department. All parties involved carry out the approvals within the DMS electronically.
- After successful approval, the document coordinator puts the temporary work instruction into effect immediately. The DMS ensures that the original work instruction is temporarily suspended. The new temporary work instruction can now be applied to the replacement device. At the same time, the coordinator sets a deadline in the DMS for the temporary instruction to expire automatically. This period of time is identical to the duration of the replacement device. The DMS ensures that the original work instruction will be used again at this point in time.
- In individual cases, it can be shown that the replacement device is permanently in use due to its better performance. The document coordinator now has the option of declaring the temporary work instruction as a new permanent work instruction. The DMS then creates a new version of the original work instruction and integrates the text content of the temporary work instruction into the new version. The coordinator submits a regular change request to the Quality Department explaining why both the replacement device and the temporary work instruction should now be permanently used.
- After approval of the change request, the document coordinator also submits the new version of the working instruction for approval. Once the electronic approval has been obtained, the coordinator puts it into effect immediately. The DMS ensures that the temporary work instruction is invalidated. The new version of the work instruction can now be permanently applied to the replacement device.
Solution from the user’s point of view (excerpt)
The document coordinator creates a TDC for an existing, valid SOP:
The TDC is automatically linked to the original SOP via relation:
After a successful approval process, the expiry date for the TDC is automatically calculated based on the expiry days and the effectivity date:
If necessary, the document coordinator can set the TDC as a new “permanent” SOP version before the expiry date:
The original SOP is automatically versioned to a new draft and gets the text of the TDC:
Technical implementation (excerpt)
The outlined business process is implemented on the basis of OpenText Documentum for Life Sciences. By customizing the TDC functionality at D2 level, it integrates seamlessly into the OpenText Documentum for Life Sciences solutions.
A D2 Creation Profile is used to copy an existing SOP or work instruction. Both content and attributes are inherited:
The expiration date for the TDC is calculated on the basis of the customer-specific expiry days field:
A dynamic D2 context automatically invalidates the TDC:
A pseudo lifecycle state makes it possible to make the TDC a permanent, new SOP. A server method provides a correct link between the original SOP and TDC using a Documentum relation:
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Here you can find the first part of my blogpost series »Special use cases based on OpenText Documentum for Life Sciences«: > The Extremely Efficient Efficiency Hold