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Validation Services

Source Stability Storage Solutions offers validation services including an online secure portal which gives full access to accurate remote monitoring and mapping with a full audit trail and automatic report generation directly from our environmental cabinets, reach-in rooms, walk in rooms, and cold rooms.

We use a combination of UKAS (United Kingdom Accreditation Service), NIST (National Institute of Standards and Technology) calibrated equipment and state-of-the-art data acquisition systems, we can offer extensive Temperature, Relative Humidity and Light Distribution mapping.

Validation Services

Validation and Calibration

 

Our Field Service Validation Engineers will enhance uniformity to ensure all equipment is performing to optimum levels. All data acquisition systems used by our Field Service Validation Engineers are fully configurable to the customers’ requirements, conforming with 21 CFR Part 11 and ensure data integrity throughout the validation process.

Our standard templates or custom documentation allows us to generate comprehensive validation protocols that will demonstrate compliance to both ICH/MHRA guidelines and FDA requirements. Every aspect of validation and calibration can be undertaken, including:

 

  • URS (User Requirements Specifications)
  • FDS (Functional Design Specification)
  • FAT (Factory Acceptance Test)
  • IQ (Installation Qualification)
  • OQ (operational Qualification)
  • CQ (Calibration Qualification)
  • PQ (performance Qualification)

 

 

 

 

 

 

 

 

Remote Monitoring

 

Our range of data acquisition systems utilise the latest wireless technology allowing for collection of data from temperature and humidity sensors amongst other connectable inputs.  With seamless integration into our i-Storage Client Portal or from multiple devices, users can monitor and control all aspects of the environmental chambers from one secure location via the internet.

The modular system of hardware elements and web-based software allows for maximum flexibility ensuring ease of installation and expandability.

The range of data loggers are designed to meet or exceed the requirements of 21 CFR Part 11 as well as EU Annex 11.  The system has been designed to meet the requirements of GAMP5 (Category 4)

 Benefits

  • Alarm overview
  • Alarm alerts via interactive phone, texts and E-Mails
  • Full audit trail
  • Monitor multiple locations
  • Scalable
  • Automatic report generation
  • Customisation
  • FDA 21 CFR Part 11 & EU Annex 11 complaint
  • GAMP©5 conform for cGxP applications

 

 

 

 

 

 

 

 

 

 

 

Remote Mapping

 

By utilising our i-Storage client portal, you gain immediate access to our remote mapping service.  This non-intrusive service utilises state of the art wireless mapping systems via the chambers internal communication devices to undertake mapping of environmental chambers at the touch of a button from one of our global validation hubs.  Our Validation experts can remotely link to the chambers control systems via secure communication and undertake mapping activities remotely, whilst generating comprehensive protocols delivered directly to the i-Storage client portal to demonstrate equipment compliance.

Benefits

  • Cost Effective
  • Saleable and Flexible
  • Non-Intrusive
  • Time Saving
  • Report/Documentation Availability
  • Full Traceability
  • Fully compatible with i-Storage