Are all environmental parameters under control to release my products? Our monitoring solution lets you monitor your GxP environmental parameters and cut your validation costs. Answers for infrastructure.
Reduce validation efforts with CMT No other industry is subject to more regulations than the life science industry. Legal regulations specify that environmental parameters which may negatively affect product quality and thus patient or consumer health must be continuously monitored by validated systems. We offer a standardized solution – Compact Monitoring Technology (CMT) – to comply with these exacting demands.
Comply with regulatory requirements with CMT I nternational health protection regulations European and American authorities define measures* that must be carried out to protect public health and safety. One of these measures involves providing documentary evidence that environmental conditions which have a direct impact on product quality – such as temperature, humidity, air pressure and particle measurements – are recorded and saved in a tamper-proof form.
Step 1: Service Step 2: Technical solution Impact analysis and risk assessment Data conversion and storage for trending and reporting Backup and archiving functions Fast compilation and easy access to data Step 3: Validation IT security Validated solution Step 4: Service Maintain validated status Physical security CMT – four steps to a solution Service – identifying your quality-relevant environmental parameters Based on our expertise, we offer competent impact analysis and risk assessment support
Technical solution – compliance with all regulations through CMT We enable accurate measurements for precise monitoring of relevant environmental conditions. Step 1: Service Step 2: Technical solution Creating trends and reports for product release All quality-relevant parameters are monitored and backed up on an ongoing basis. Just one click of the mouse creates a full report of the data containing all information for your product release.
Technical solution – highest degree of security protects your sensitive data Thanks to integrated IT security functions, CMT ensures that you do not lose any data and that you comply with 21 CFR Part 11. Step 1: Service Step 2: Technical solution Regular data backups and archiving The system backs up your data hourly, daily, and weekly and stores it in archives over the long term. All CMT data is backed up to an external hard drive on a regular basis.
GAMP 5 Risk-based approach GAMP 5 IQ/OQ phase reduced User Requirements Specification Requirements Testing Initial Risk Assessment Initial Risk Assessment Functional Specification Functional Risk Assessment Functional Testing Configuration Specification Configuration Testing Functional Risk Assessment Configured Product CMT Configurable Product Siemens QMS V-model according to GAMP 5 Validation – faster validation, better quality The pre-tested CMT solution, which is pre-documented according to
Advantage Service Program for the pharmaceutical industry Service – maintaining your validated status over the long term Initial validation is the first challenge, but maintaining your validated status during system operation is just as important and challenging.
Step 1: Service Impact analysis and risk assessment Step 2: Technical solution Step 3: Validation Data conversion and storage for trending and reporting Backup and archiving functions Full reporting functions Increased security Fast compilation and easy access to data IT security Validated solution Step 4: Service Maintain validated status Physical security Greater convenience Deeper integration Additional features CMT – four steps to a solution CMT grows with your requirements CMT offers a c
A single solution for different needs Seamless monitoring of refrigerators and freezers at the Klinikum Pforzheim hospital. Case study: Klinikum Pforzheim/ Germany The Institute for Transfusion and Laboratory Medicine provides medical laboratory and transfusion services for patients of the Klinikum Pforzheim hospital. The institute has a blood bank, which provides erythrocyte concentrates, FFP and thrombocyte concentrates to several hospitals in the region.
Functional scope of the technical solution 11
Controller (PX modular) Intelligent data collection and data storage even if the connection to the data center (server) is interrupted Integrated temperature sensor Measures the temperature inside the control cabinet 3-level alarm Integrated display with three different system alarms: • Green – everything is ok • Yellow – warning • Red – alarm Safety lock Ensures physical security; restricts access to authorized staff only Intelligent system (Reporting and Archiving) The system‘s data processing center
Case study: hospital pharmacy Extensive monitoring of the production of application-ready cytostatic solutions at the Orbis/Sittard Medical Park. ase study: Orbis Medical Park/ C the Netherlands Orbis Medical Park (OMP) in Sittard- Geleen, the Netherlands, is the best example of the future of health care. Together with Siemens, Orbis has created a twenty-first century hospital, which allows Orbis to offer better and more health care at a lower cost.
Answers for infrastructure. ■ Megatrends driving the future The megatrends – demographic change, urbanization, climate change, and glo balization – are shaping the world today. These have an unprecedented impact on our lives and on vital sectors of our economy.
