IMA LIFE Freeze drying solutions can support the customer in assessing its control system with respect to compliance with current regulations, including GAMP IV and 21 CFR part 11.
IMA LIFE Freeze drying solutions can also provide control system upgrades for: SCADA, PLC, field instrumentation.
The control system upgrades will allow 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 is fully debugged and bench tested in a simulation environment.
A full factory acceptance test (FAT), normally performed with the participation of 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:
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Validation master plan |
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User requirements specification |
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Design qualification/traceability matrix |
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Functional design specification for PLC: block diagrams and pin chart |
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Functional design specification for SCADA |
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Hardware design specification |
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Software design specification for PLC and SCADA |
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FAT (factory acceptance tests) and SAT (site acceptance tests) |
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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.
After the installation on site is complete, IMA LIFE can also assist the customer during the control system's total life cycle.
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Solid Dose Processing / Manufacturing
Aseptic Processing & Freeze Drying
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