Validation Protocol and Report Procedure | ISO 13485 | FDA QSR Compliant
$99.00
$99.00
per item
The ISO 13485 Validation Protocol and Report Procedure governs the structure and content of all validation protocols and reports (IQ, OQ, PQ and PPQ) made part of product development and process validation.
- ISO 13485:2016 Compliant
- FDA QSR Compliant
- MS Word Format
- Digital Content - Instant Download
SKU:
SOP 7-015
ISO 13485 Protocol and Report ProcedureThe Validation Protocol and Report Procedure governs the structure and content of protocols and reports related to equipment, process and product.
ISO 13485 Protocols and Reports Procedure OverviewThe Validation Protocol and Report Procedure instructs on the development of Installation Qualification (IQ) Protocols, Operational Qualification (OQ) Protocols, Performance Qualification (PQ) Protocols and Product Performance Qualification (PPQ) Protocols.
The Validation Protocol and Report Procedure also provides instruction on the format and required content of all validation final reports. ISO 13485 Protocol and Report Procedure ComplianceThe Validation Protocol and Report Procedure is FDA QSR and ISO 13485:2016 compliant.
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