Quality & Validation

CRITICAL MONITORING

FOR OUR GLOBAL ENVIRONMENT

QUALITY & VALIDATION

Facility Monitoring Systems provide robust monitoring solutions that offer a level of assurance when monitoring a specific process, equipment, facility or system.
FMS equipment and systems are fully validatable. The validation documentation for equipment testing and software life cycle has been developed following GAMP guidelines and adopting current GMP regulatory requirements.

Validation Model

Validation documentation is generated, specific to each installation and includes the following:

• Functional Specification (FS)
• Configuration Statement (CS)
• Software Integration Testing (SIT)
• Factory acceptance Testing (FAT)
• Installation Qualification (IQ)
• Operational Qualification (OQ)

Validation testing is performed by FMS trained engineers working to pre-approved protocols.  Software is developed in house by FMS programmers. Version control is maintained throughout the software lifecycle using approved test protocols and an internal change control system

The software is CFR 21, part 11 compliant. The raw data generated is suitable for regulatory submission and is incorruptible. System access is defined by security levels identified during system validation.FMS validated installations are compliant with regard to:

• “Orange Guide” Rules and Guidance for Pharmaceutical Manufacturers & Distributors
• Commissioning Directive 91/356/EEC & 2003/94/EC (Principles and Guidelines of GMP
• Directive 2001/83/EC (Medicinal Products for Human Use)
• EU Tissue & Cells Directive
• HFEA Standards for assisted Conception Centres