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A ProPharma Group knowledge center & resource

The Validation Center™ library has the documents you need to quickly implement a validation program that complies with the FDA, EMA, and ICH. These SOPS and templates follow industry standards and best practices, such as those found in PIC/S and GAMP.

Our library also provides a vast database of US and international regulations and guidelines with software implications.

Basic Package

$1,200

The Validation Center™ Basic Package of software and system compliance Standard Operating Procedures (SOPs) and Templates will expedite your implementation of a foundational computer system validation (CSV) program that complies with FDA 21 CFR 11 (Part 11) Electronic Records; Electronic Signatures.

  • 10 Standard Operating Procedure Templates
  • 14 Templates
  • 30 minutes of consulting
  • Downloads available for 15 days

Comprehensive Package

$1,950

The Validation Center™ Comprehensive Package of Standard Operating Procedures (SOPs) and Templates was designed for implementation of a software and system compliance program that complies with the expectations of the FDA, EMA, and ICH and incorporates industry standards and best practices, such as those found in PIC/S and GAMP.

  • Data Integrity Policy
  • 22 Standard Operating Procedures
  • 23 Templates
  • 60 minutes of consulting
  • Downloads available for 15 days
Document Basic Package Comprehensive Package

Standard Operating Procedures (SOP)
Disaster Recovery Planning
Preview Table of Contents
Risk-Based Computer System Validation
Preview Table of Contents
SDLC for Custom-Developed Systems
Preview Table of Contents
SDLC for Purchased Systems
Preview Table of Contents
System Access Management
Preview Table of Contents
System Backups
Preview Table of Contents
System Change Management
Preview Table of Contents
System Risk Assessment
Preview Table of Contents
System Security Requirements
Preview Table of Contents
System User Training
Preview Table of Contents
Audit Trail Review
Preview Table of Contents		  
Business Continuity Planning
Preview Table of Contents		  
Corrective and Preventive Action
Preview Table of Contents		  
Document Management
Preview Table of Contents		  
Internal Audits
Preview Table of Contents		  
IT Vendor Qualification
Preview Table of Contents		  
Periodic System Review
Preview Table of Contents		  
Personnel Training
Preview Table of Contents		  
Record Archival and Retrieval
Preview Table of Contents		  
System Retirement
Preview Table of Contents		  
System Issue Management
Preview Table of Contents		  
Validation Master Planning
Preview Table of Contents		  

Templates
Functional Requirements Specification
Preview Table of Contents
Installation Qualification
Preview Table of Contents
Operational Qualification
Preview Table of Contents
Performance Qualification
Preview Table of Contents
Part 11 Compliance Report
Preview Table of Contents
Spreadsheet Validation
Preview Table of Contents
System Design Specification
Preview Table of Contents
System Risk Assessment
Preview Table of Contents
Testing Plan
Preview Table of Contents
Testing Summary
Preview Table of Contents
Trace Matrix
Preview Table of Contents
User Requirements Specification
Preview Table of Contents
Validation Incident Report
Preview Table of Contents
Validation Plan
Preview Table of Contents
Validation Summary Report
Preview Table of Contents
Annex 11 Compliance Report
Preview Table of Contents		  
IT Vendor Qualification Audit Checklist
Preview Table of Contents		  
IT Vendor Qualification Questionnaire
Preview Table of Contents		  
Periodic System Review Report
Preview Table of Contents		  
Project Plan
Preview Table of Contents		  
Record Archival and Retrieval Plan
Preview Table of Contents		  
Validation Master Plan
Preview Table of Contents		  

Policies
Data Integrity Policy
Preview Table of Contents		  
Price Basic Package
$1,200		 Comprehensive Package
$1,950

Validation Document Library FAQ

How will I receive the documents that I purchase?

After completing the purchase, you will receive an email with a link that will take you to a portal where you'll have 15 days to download the documents.

How long will I have to download my documents?

Documents may be downloaded for 15 days after the order is placed.

How many times can I download my documents?

Purchased documents can be downloaded through the 15-day period.

What should I do if I can’t download my documents?

Please contact us if you have any issues downloading your documents.

How do I access my documents after the initial purchase?

All previously downloaded documents are available on the My Account page.

What is the format of Validation Center documents?

The Validation Templates and Software Quality SOPs are Microsoft Word documents.