Pharma Engineering Insights
What a GMP Environmental Monitoring System cost...
The cost structure of an EMS project, a model for calculating total cost of ownership, the items that are systematically underestimated, and how to build a defensible business case without...
What a GMP Environmental Monitoring System cost...
The cost structure of an EMS project, a model for calculating total cost of ownership, the items that are systematically underestimated, and how to build a defensible business case without...
How to select an EMS supplier: from URS to RFP,...
How to turn the URS into a comparable request for quotation, which questions to ask suppliers, how to build a defensible evaluation grid, and what to define in the service...
How to select an EMS supplier: from URS to RFP,...
How to turn the URS into a comparable request for quotation, which questions to ask suppliers, how to build a defensible evaluation grid, and what to define in the service...
Retrofitting an existing GMP Environmental Moni...
How to run the gap assessment of an existing Environmental Monitoring System, decide between remediation, retrofit and replacement, and manage the work in an operating facility without losing data continuity.
Retrofitting an existing GMP Environmental Moni...
How to run the gap assessment of an existing Environmental Monitoring System, decide between remediation, retrofit and replacement, and manage the work in an operating facility without losing data continuity.
Calibration, maintenance and periodic review of...
Calibration programme, handling of out-of-tolerance results, preventive maintenance, data review and periodic review: how to keep an Environmental Monitoring System in a state of control after release to operation.
Calibration, maintenance and periodic review of...
Calibration programme, handling of out-of-tolerance results, preventive maintenance, data review and periodic review: how to keep an Environmental Monitoring System in a state of control after release to operation.
FAT, SAT, IQ, OQ and PQ of an Environmental Mon...
What is verified in FAT, SAT, IQ, OQ and PQ of an Environmental Monitoring System, how to build the traceability matrix from requirements to tests, and how system qualification differs...
FAT, SAT, IQ, OQ and PQ of an Environmental Mon...
What is verified in FAT, SAT, IQ, OQ and PQ of an Environmental Monitoring System, how to build the traceability matrix from requirements to tests, and how system qualification differs...
Environmental Monitoring System software: Annex...
User roles, segregation of duties, audit trail, electronic records, archiving and periodic review: how to set up the computerised part of an EMS under the applicable Annex 11 and data...
Environmental Monitoring System software: Annex...
User roles, segregation of duties, audit trail, electronic records, archiving and periodic review: how to set up the computerised part of an EMS under the applicable Annex 11 and data...
