IMA Swiftpack is able to provide standard IQ and OQ protocol packages for both individual machines and integrated packaging lines consisting of the following:
IQ/OQ Document Revision History, Scope and Objectives.
IQ/OQ Equipment Process Description.
IQ/OQ Responsibility and Approvals.
IQ Confirmation of scope of supply.
IQ Product contact parts identification and certification.
IQ Instrument calibration schedules and procedures.
IQ Preventative maintenance schedules and procedures.
IQ Supporting Documentation verification.
IQ Utilities requirements confirmation.
IQ Safety and Security systems verification.
IQ Appendices; Appended copies of the following:
- Copy of Customer Purchase Order (and Supplier Order Confirmation, where necessary).
- Copy of Supplier internal test procedures evidence.
- Copy of Factory Acceptance Test protocols.
- Copy of Line Layout (where applicable).
- Copy of product contact parts certification.
- Copy of Calibration Certificates (where applicable).
- Copy of Preventative Maintenance Procedures.
- Copy of CE Certification of Compliance (or incorporation, where applicable).
OQ Installation Verification.
OQ Functional Testing Protocols.
In addition, IMA Swiftpack is able to provide comprehensive on-site assistance during execution.
The IQ/OQ packages can also be tailored to individual customer requirements.
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