Control System Upgrades

IMA EDWARDS can support you in assessing your control system with respect to compliance with current regulations, including GAMP IV and 21 CFR part 11.

We can also provide control system upgrades for:

• SCADA
• PLC
• Field instrumentation

The control system upgrades will allow you to meet the most restrictive regulatory requirements—in particular, full compliance with 21 CFR part 11.

The software for both control systems at PLC level and supervisory systems are fully debugged and bench tested in a simulation environment.

A full factory acceptance test (FAT), normally performed with the participation of our customers, completes the activities performed at factory. This provides an optimum level of confidence that the installation and the subsequent site acceptance test (SAT) will be smooth and trouble-free.

The control system upgrades include a documentation package fully compliant with the GAMP IV requirements. It may include:

• Validation master plan
• User requirements specification
• Design qualification/traceability matrix
• Functional design specification for PLC
      - Block diagrams
      - Pin chart
• Functional design specification for SCADA
• Hardware design specification
• Software design specification for PLC and SCADA
• FAT (factory acceptance tests) and SAT (site acceptance tests)
• Test protocols

The whole process will be developed and regulated by approved procedures and practices, such as change control and deviation management, which can be fully audited per customer requirements.