Unit 37-38 The Technology Centre,
Monitoring is a major challenge in the pharmaceutical industry. And this is where we can support you.
Whether statutory provisions, common industry standards or customer-specific requirements: there are many reasons for using a S!MPATI® monitoring system. This applies in particular to the pharmaceutical industry and pharmacies as well as to biotechnology companies, special fields of medical technology and temperature-controlled logistics (GDP). In the face of ever-increasing quality requirements, demand is also growing steadily in the food and automotive industries.
The core task of a monitoring system is the safe monitoring and documentation of certain parameters such as room pressure, temperature, airborne particles, pH value, conductance, etc. As a smart software solution, S!MPATI® monitor also offers a number of other benefits. The flexible control and documentation software can also be used for existing devices that are equipped with the S!MPAC® measuring and control system in order to realise holistic monitoring. In addition, it can be adapted and expanded in a variety of ways. The S!MPATI® monitor software package, being based on S!MPATI® pharma, meets the requirements of FDA 21 CFR Part 11 and Annex 11 of the EU GMP guidelines.
S!MPATI® monitor meets the following requirements:
• Audit trail
• Electronic records are data and manipulation-proof according to the manufacturer’s specifications
• Qualification, validation and change control
• Individual user rights
• Recording of alarms and doors opening and documentation of opening times