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Quality
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Gamp 5 ONG Overview
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Computerised Systems:
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Most computerised systems are now based on configurable packages, with many of them
networked. Hence only Validate were there can be an impact on Customer / Patient
/ Safety, Product Quality, Data Integrity. If none of these are impacted there should
be no need to validate. Good engineering practice is sufficient with Gamp documented
procedures in operation.
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Process Owners:
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We Need to be clear on the differences between system owner and process owners.
QA should be less involved than in the past. For example QA should review a URS
against the applicable regulations. URS technical review is for technical subject
matter experts and designers. QA does not need to sign a design spec, as they do
not understand its contents technical SMEs are required to sign, as they have the
expert knowledge.
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Quality Assurance:
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QA must verify that design specs are being produced for projects (i.e. verify that
Processes / Procedures are being followed) but QA does not need to sign every document
in a project. In other words QA should sign quality documents (e.g. URS, Validation
Plans, Project Plans, Code Reviews), (e.g. design spec). At ONG Engineering the
Project Management plays a key role in the final approval of Design Specifications
along with the SME's for finished product design output documents.
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Document Signatures:
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Historically far to many signatures have been required on documents, moving to limit
more reasonable signature numbers. Its suggested a maximum of three signatures per
document. Ask if signatures really add value. Don’t waste time, resources
and cost.
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GAMP Category 2:
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GAMP category 2 (firmware) has been removed from the old standard. Firmware has
become so complex that it is no longer functionally distinguishable from software.
Changes have been implemented to the descriptions of the GAMP category types.
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Supplier Qualification:
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It’s Important to know if suppliers are outsourcing. This will need careful
control to ensure whether suppliers are suitably qualified. There is a need to have
a Quality Plan or supplier audit with your supplier, verify suppliers have quality
processes such as On Time Delivery mesurements, change control, root cause analysis
or approved ISO Systems in place. Support post go-live needs to be considered, especially
with small suppliers.
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Leveraging of supplier documents and Audits are vital, this needs to be carefully
evaluated with suppliers to ensure that on time delivery,quality,cost inclusive
of documents will be of a suitable standard.
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Acceptence Testing:
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Testing is integrated into the Life Cycle Phases at ONG. We build "Acceptance Testing"
into the process for Code Reviews( FAT / FDS / SAT), with Commissioning, Qualification
documentation and Handover documents.
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Provide evidence at all levels "Especially Test Plans built into the Risk Assessment
of Projects". At ONG project management takes responsibility for all test
and inspection activities, to ensure they are planned in advance and conducted and
documented professionally to suit our customers. Compliance is key to all our activities.
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