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FDA Validation Tools Kit

Simplify FDA Validation...


PolicyTech Validation Package
In order to help expedite your validation process of our Policy & Procedure Manager software, PolicyTech
provides the FDA Validation Tool Kit to help achieve21 CFR Part 11 and 820 compliance.
FDA Validation Tool Kit Package
You are probably already aware that validation consulting for third party computer systems can be costly.
With this in mind, weve designed our FDA Validation Took Kit Package to be an effective and economical solution. This Tool Kit will assist key project members to complete the essential validation requirements. FDA
Validation Toolkit Templates include:
Introduction to Validation:
Includes clear documentation outlining duties that need to be executed throughout the validation process.
Quality and regulatory affairs managers will receive clarification of the scope and dedication required to successfully complete compliant computer systems validation for Policy & Procedure Manager.

Certification memo to the FDA:


This is a sample memo that every company must send to the FDA when using an electronic document control
system that collects electronic signatures.

Validation plan:
The FDA does not tell you how to validate your computerized system, but insists that you tell them how you
intend to validate it. We have created a simple step by step plan/template for you to meet this requirement.

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Risk management plan:
This is created to clarify potentional risks, determine the level of risk, and create response plans to mitigate
these risks. Within the validation package, we have included a sample risk management analysis and plan.

Documentation that explains:


User requirements specification (URS)
Functional requirements specification (FRS)
Software requirements specification (SRS)

Test Script (TS):


The FDA requires that you verify through evidence that the system actually functions as expected. This can be
done by following the test scripts we have created for document owners, reviewers/approvers, and administrators. We also will provide you with sample reports you can create that show that these tests were performed.

URS, FRS, TS Trace Matrix:


These matrices trace user requirement specification and functional requirement specifications to the test
scripts. This is done to show that all requirements have been sufficiently tested.
Operational Qualification (OQ)- This document assists in the verification that all facets of the software operate
correctly.

Installation Qualification (IQ):


This template will give you something to follow to demonstrate that the software meets all technical specifications, is installed correctly, and all required components and documentation needed for continued operation
are installed and in place.

Performance Qualification (PQ):


This will help you demonstrate that the software consistently performs as intended.

Validation report:
This document will explain how you followed your validation plan and what the end results were.

FDA software validation is extremely time consuming and can be very confusing, but it does not have to be.
By using our comprehensive FDA Validation Toolkit, you will have a simple guide with multiple templates
which include everything you need to complete your FDA validation. If your organization has limited experience with validation projects or you need more assistance beyond this Tool Kit, please call us and we can
provide qualified third-party consultants who will be happy to assist you.