FDA QMSR Process Validation Template Set

¥319,500

FDA QMSR Process Validation Template Set

FDA QMSR Process Validation Template Set

¥319,500

Process Validation templates for FDA QMSR compliance.

Quantity

SOLD OUT

✅ Common Features Across All QMS Templates

🇺🇸 FDA QMSR (21 CFR Part 820)
·
🌐 ISO 13485:2016 §7.5.6
·
📝 MS Word (.docx)
·
🔄 Immediate Use
·
🎬 Video Guidance on YouTube

Overview

A complete process validation template set for FDA QMSR compliance. Covers IQ/OQ/PQ protocols, equipment qualification, manufacturing process design, FMEA-based risk management, and validation planning for all special processes.

Regulatory Reference: ISO 13485:2016 §7.5.6 — Validation of Processes for Production and Service Provision

Why You Need This

ISO 13485:2016 §7.5.6 requires validation of all special processes where output cannot be fully verified. Process validation failures are among the most serious FDA findings, potentially requiring product recalls.

What’s Included

Document Type Description
📄 Policy Document 1 file — Organizational policy & management framework
📋 SOP / Procedure MD-QMS-S702 Manufacturing Process Design SOP
📋 SOP / Procedure MD-QMS-S707 Equipment Qualification SOP
📋 SOP / Procedure MD-QMS-S709 Production Process Risk Management SOP FMEA
📋 SOP / Procedure MD-QMS-S7501 Process Validation SOP
📝 Form / Template FM-S709-02 Equipment Qualification Plan
📝 Form / Template FM-S709-03 DQ Results Report
📝 Form / Template FM-S709-04 IQ OQ Results Report
📝 Form / Template FM-S709-05 PQ Results Report
📝 Form / Template FM-S709-06 PV Implementation Plan
📝 Form / Template FM-S709-07 PV Implementation Report
📝 Form / Template MD-QMS-F722 Validation Plan Protocol
📝 Form / Template MD-QMS-F724 QC Process Flow Chart
📝 Form / Template MD-QMS-F725 Design Transfer Checklist
📝 Form / Template MD-QMS-F727 Process Change Request Form
📝 Form / Template MD-QMS-F7501 PV Execution Plan
📝 Form / Template MD-QMS-F7501 PV Implementation Plan
📝 Form / Template MD-QMS-F7502 PV Execution Report
📝 Form / Template MD-QMS-F7502 PV Implementation Report
📝 Form / Template MD-QMS-F771 Equipment Qualification Plan
📝 Form / Template MD-QMS-F772 DQ Execution Results
📝 Form / Template MD-QMS-F772 Equipment Qualification Plan
📝 Form / Template MD-QMS-F773 DQ Execution Results
📝 Form / Template MD-QMS-F773 IQ OQ Execution Results
📝 Form / Template MD-QMS-F774 IQOQ Execution Results
📝 Form / Template MD-QMS-F775 PQ Execution Results

📋 Policy — Table of Contents

Purpose
Scope
Normative References
Definitions
General Policy
Risk-Based Approach to Validation
Processes Requiring Validation
Decision Criteria for Validation
Types of Process Validation
Equipment Qualification
Validation Protocol Requirements
Sample Size and Statistical Methods
Software Validation
Revalidation
Event-Driven Revalidation
Periodic Revalidation
Records
References
Supplementary Provisions

📋 MD-QMS-S702 Manufacturing Process Design SOP — Table of Contents

Purpose
Scope
Definitions
Roles and Responsibilities
General Policy
Validation Master Plan (VMP) Development
Validation Plan/Protocol (VP) Development
Process Design Specification Development
QC Process Flow Chart Development
Infrastructure and Equipment Preparation
Equipment Qualification
Process Validation (PV) Execution
Continued Process Verification (CPV) Program
Work Instruction Development
Design Transfer
Phased Release to Production
Process Change Control
Change Initiation
Change Evaluation
Change Implementation
Corrective and Preventive Action (CAPA) Requests
Record Management
MDF (Medical Device File) Integrated Records Management
Data Integrity and Cybersecurity
Forms
References
Supplementary Provisions

📋 MD-QMS-S707 Equipment Qualification SOP — Table of Contents

Purpose
Scope
Definitions
Roles and Responsibilities
Equipment Qualification Process
FMEA Execution
Qualification Plan Development
Design Qualification (DQ) Execution
Installation Qualification (IQ) and Operational Qualification (OQ) Execution
Performance Qualification (PQ) Execution
Requalification
Record Retention
Forms
References
Supplementary Provisions

📋 MD-QMS-S709 Production Process Risk Management SOP FMEA — Table of Contents

Purpose
Scope
Definitions
Roles and Responsibilities
FMEA Planning and Team Formation
Risk Identification
Risk Analysis and Evaluation
Risk Control Implementation
Post-Mitigation Risk Re-Evaluation
FMEA Re-Evaluation for Design/Process Changes
References
Supplementary Provisions
Record Retention
Training
Integration with Post-Market Surveillance
Periodic Review
Forms

📋 MD-QMS-S7501 Process Validation SOP — Table of Contents

Purpose
Scope
Definitions
Roles and Responsibilities
Risk Assessment
Validation Planning
Validation Execution
Event-Driven Revalidation
Periodic Revalidation
Record Retention
Forms
References
Supplementary Provisions

Key Features

  • Fully aligned with ISO 13485:2016 §7.5.6 (Validation of Processes for Production and Service Provision)
  • Written for immediate use — minimal customization required
  • Structured for FDA QMSR (21 CFR Part 820) compliance
  • Microsoft Word format (.docx) — easy to edit and adapt
  • Professional quality suitable for FDA inspection review
  • Includes all required procedural elements and record templates
Reviews

Related products

Recentry viewed products