ISO 13485 Process Validation Procedure Bundle
SKU:
PROCESS-BNDL
$399.00
$399.00
per item
The ISO 13485 Process Validation Procedure Bundle includes 4 procedures related to the validation of medical device processes. The process validation procedures are ISO 13485:2016 and FDA QSR compliant.
- ISO 13485:2016 Compliant
- FDA QSR Compliant
- MS Word Format
- Includes Related Form(s)
- Digital Content - Instant Download
ISO 13485 Process Validation Procedure BundleThe Process Validation Procedure Bundle includes four (4) ISO 13485:2016 compliant procedures related to medical device process validation. The process validation procedures are both practical and well suited to govern process validation activities within your organization.
Process Validation Procedure Bundle - OverviewProcess Validation Procedure
The Process Validation Procedure provides instruction for determining when process validation is required, validation pre-requisites, and overall strategy. The procedure also includes information on worst case product selection, validation lots, test methods and acceptance criteria. Validation Protocols and Reports Procedure
The 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. Installation Qualification Procedure
The Installation Qualification Procedure applies to the installation of new equipment, moving or relocating equipment, or after equipment modifications. The Installation Qualification (IQ) Procedure provides instruction on the requirements of conducting Installation Qualifications (IQ's). Statistical Techniques Procedure
The Statistical Techniques Procedure provides guidance on statistical analysis methods used to support medical device sampling plans, failure analysis and validation data analysis. Process Validation Procedure Bundle - ComplianceThe Process Validation Procedure Bundle content is ISO 13485:2016 and FDA QSR Compliant.
To learn more about our ISO 13485 Process Validation Procedure Bundle contact us at info@aplyon.com
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Process Validation Procedure Bundle Content
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Medical Device Process Validation Procedure
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The Medical Device Process Validation Procedure provides guidance on medical device process validations. The ISO 13485Process Validation Procedure applies to all medical device manufacturing processes requiring validation prior to the commercial release of product.
- ISO 13485:2016 Compliant
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- MS Word Format
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Validation Protocol and Report Procedure | ISO 13485 | FDA QSR Compliant
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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.
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- FDA QSR Compliant
- MS Word Format
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Statistical Techniques Procedure | ISO 13485 | FDA QSR Compliant
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The ISO 13485 Statistical Techniques Procedure provides guidance on statistical analysis methods used to support medical device sampling plans, failure analysis and validation data analysis.
- ISO 13485:2016 Compliant
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- MS Word Format
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Installation Qualification IQ Procedure | ISO 13485 | FDA QSR Compliant
$149.00
The ISO 13485 Installation Qualification (IQ) Procedure governs the installation of equipment used to manufacture medical devices and all test equipment used to release product.
- ISO 13485:2016 Compliant
- FDA QSR Compliant
- Includes Related Forms
- MS Word Format
- Digital Content - Instant Download