This simplified schematic shows the workflow of a GMP document, which is initiated with a change control order, then prepared, reviewed, approved, trained, and finally released. If there is a previous revision of the document, it is taken out of circulation and archived, before the new revision is released.
All steps in the light green rectangle are performed in TEMIS, only change control and trainings are to be performed externally. However, future TEMIS updates foresee addons for both, as well as a feature for the use of electronic signatures.
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Our software solution TEMIS is now available for implementation!
TEMIS fills a gap in the pharmaceutical industry for an affordable, yet powerful GMP-compliant document management system.
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Enterprises in the industry are required to comply with exceptionally high regulatory requirements, for their products have a significant impact on human life, whether directly or indirectly.
Even though we live in a digital world nowadays, when it comes to the industry requirements for the management of electronic records, many are still lagging behind. There is no feasible solution that is both GMP-compliant and affordable for small and medium-sized enterprizes. You are given the the choice to either invest six digits into a system or to resort to an insufficient digital or an entirely paper-based documentation system. Until now …
With TEMIS we have developed a solution that will help you keep your documents, different versions and document metadata under control, helps you to oversee and manage common document workflows (preparation, approval cycle, training, release, archiving), grant different kinds of access permissions to various users depending on their role inside your organization, and finally a smart tracking system records changes of all that is defined as critical information.
TEMIS can also be highly customized to your specific needs and requirements. If you have an already established documentation system or if you don’t but have a concept in mind how you would like to organize your documents, we can take that into account in TEMIS, so users feel right at home when filing and retrieving documents. In addition, using a dynamic and flexible documentation system will prove highly valuable for inspections.
This short (muted) video gives a quick once-over of some basic TEMIS functionality: A new document is created by the Manager, then assigned to a Key User, who then starts entering persons to the list of approving parties.
TEMIS is available in three different package variants:
- R&D package: TEMIS without validation. Ideal for university institutes or R&D-only enterprises who do not need to work under GMP but might in the future
- GMP Standard package: TEMIS as is with the complete validation documentation to set it up in GMP-compliant environment
- GMP Premium package: TEMIS, the same as standard, but with access to extended support and training, and access to planned future upgrades like training, change control management and electronic signatures
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