Alongside our standard S!MPATI® software package, we have also developed a version tailored for the pharmaceutical industry that allows even better use to be made of our pharma equipment and systems. S!MPATI® Pharma ensures simple and reliable recording and archiving of data.
All warning and alarm signals are recorded. If necessary,arranging the information of the person in charge of the alarm signal. The access rights of each user can be set individually; the data is recorded and stored in a manner that is manipulation-proof, but it can be still processed e.g. in Excel.
The S!MPATI® Pharma software package of course fulfils FDA 21 CFR Part 11 and Annex 11 of the EU GMP guidelines. In addition, validation documents are provided for the S!MPATI® Pharma monitoring system.
Furhter to the advantages of our standard S!MPATI® software package, the pharma version offers the following sector-specific advantages:
- Individual user administration
- Manipulation-proof system and manipulation-proof recording of data
- Audit trail
- Recording of alarms, doors opening and documentation of opening times
- Recording of all process parameters such as temperature, humidity as well as light and UV intensity during photostability tests
- Taking into account the alarm system on the devices, S!MPATI® Pharma fulfils all five steps in the risk-based approach as per GAMP 5
- S!MPATI® Pharma is a Category 3 software package as per GAMP 5