Design & Installation

CRITICAL MONITORING

FOR OUR GLOBAL ENVIRONMENT

DESIGN & INSTALLATION

We ensure that our monitoring technology satisfies the demands of the various regulatory bodies. Each system is designed to adhere to the requirements of the ISO and 209E Standards, FDA and the EU-GMP Annex 1 guidelines. Key to achieving this is our expertise in providing fully validated solutions.

Our systems show that you comply.

Support Services
Our support and technical services are tailored to your specific requirements. With the need for traceability and regulatory compliance we offer the following services:

• Full system validation lifecycle documentation based on GAMP
• Design of bespoke monitoring systems and software to meet the requirements of the FDA, EU-GMP Annex 1 and continuing demands of 21 CFR Part 11.
• Full Validation documentation includes, but is not limited to, the following:
• User Requirement Specification (URS)
• Quality and Project Plan (QPP)
• Functional Specification (FS)
• Hardware/Software Design Spec. (DS)
• System Integration Test (SIT)
• Factory Acceptance Testing (FAT)
• Site Acceptance Testing (SAT)
• Installation Qualification (IQ)
• Operational Qualification (OQ)
• Validation completion report

Design
We design and supply systems to your specification. New technology can be integrated with existing systems. Our validation plans can be as simple or comprehensive as you require. Assistance with the production of the initial User Requirement Specification (URS) through to Standard Operating Procedures (SOPs), Performance Qualification (PQ) and risk assessments is available.

Installation
The system can be built and tested in house prior to delivery. Our installation team can then install and implement your new monitoring system. As part of the validation plan full operator and system manager training is given.

The FMS monitoring software has full GAMP development lifecycle documentation maintained and is in compliance with FDA 21 CFR Part 11.

Service & Support
Our services include on-site calibration, technical support and extensive training packages for new and existing members of staff. We will make sure you get reliable and accurate results well into the future.