Q1 Scientific provides the pharmaceutical, medical device and life sciences industries with world-class stability storage facilities. As a dedicated storage provider, they have a clear understanding of their customer needs and expectations. With more than 60 modern stability rooms operating at a wide range of conditions and all within strict pharmaceutical regulations, Q1 Scientific have won multiple awards and proven themselves as a pioneer within the Irish industry since they first opened in 2012.

The Application

Continuous monitoring is a critical requirement for stability storage. Clear evidence must be available demonstrating conditions for 365 days a year, 24 hours a day. In addition, stability and gradients within the chambers must be checked regularly by mapping.
If conditions begin to stray outside the set tolerance, notifications must be sent immediately so action can be taken to ensure products are not affected. The result of all these regulations is a large number of measurement devices which all require routine calibration for temperature and humidity.

The Challenges
Over the past 8 years Q1 Scientific have used continuous monitoring systems from many major global suppliers, including both wired and wireless solutions. As such the quality and management personnel at Q1 scientific were able to draw on a wealth of experience to ensure that they found the very best system for their needs. A comprehensive risk based approach was used, which included a review of the infrastructure, hardware, software, support, calibration, and validation of each system.

Clear Data, simple interpretations
During a routine support call that was made to the site, Marie Morrisey (Stability Lead) explained that the clear and simple 4 hour summary charts used on their displays had proven more beneficial than they ever could have imagined. With just a quick glance at the charts, Marie was able to identify one chamber that was showing some signs of increased stability whilst staying within alarm limits.

Upon further investigation, it was found that a water pump was beginning to fail. A quick fix that without being detected early could easily have resulted in an out of tolerance event. The ease of access and trust in the system has ensured that when events occur personal can respond quickly. Reports, alarm and warning summaries, and a comprehensive audit trail showing all activities and acknowledgements mean that senior managers can easily review the facility as a whole and quickly present data to customers and auditors.

Compliance in the cloud
There is growing support for cloud based software solutions in the Pharmaceutical industry it is important to remember, however, that any solution (cloud based or on premises) has its own risks and in line with GAMP5 guidelines, projects should always take a risk based approach. Decisions should be made based on a thorough risk analysis as part of a quality risk management process. The Rotronic Monitoring System cloud service is run to some of the highest standards available. The software is hosted in a Tier 4 data centre, with ISO 27001 certification. Our SaaS IT compliance document clearly demonstrates the degree to which we continually invest to ensure security, data integrity and continuous operation. Such standards are often far higher than those available to users of on premise software installations.

In the event of site wide loss of internet connectivity, all data is safely logged and displayed locally by the instruments themselves. Upon reconnection, RMS automatically backfills and analyses the data for any deviations. Detailed validation documentation and built in validation functions ensure initial and ongoing validation and use of the RMS platform is simple, robust and compliant.

Product Focus
Validated Cloud Rotronic Monitoring System (RMS)
• Full FDA 21 CFR Part 11 and EU Annex 11 compliance
• Designed ground up to comply with and be used
within validated GxP applications
• Simple tools for data analysis designed around
audits and assessments
• Configurable scripts to test core functions with
clear reports
• On going software development following
GAMP5 process

Validation Support
• Clear validation documentation including detailed
system risk assessment
• Comprehensive eCompliance White Paper detailing
how RMS meets regulatory requirements
• Access to a network of validation engineers
specialising in system validation

Thanks for reading

Best Wishes

Rotronic UK.

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