FDA Validation Toolkit for PolicyTech Regulatory Compliance

FDA Validation Toolkit for PolicyTech
Helps Life Sciences, Pharmaceutical and Medical Device Companies Maintain
Regulatory Compliance
Software validation is a must-do for today’s highly-regulated life sciences organizations.
Validation and verification is required by the Food and Drug Administration (FDA) to ensure that
any enterprise-wide systems your company is using has clear user requirements that defines the
intended use of the system and that you are strictly upholding these requirements over time.
The FDA Validation Toolkit for PolicyTech will help you identify critical control points to determine the degree
of testing required, the focus for your testing efforts and development of a risk mitigation plan – all resulting
in better, smarter testing. The Toolkit assists you in determining the full spectrum of your associated risk from
legal to regulatory, technical to external.
The FDA and other similar regulatory agencies worldwide validate a manufacturer’s implementation and
use of a vendor’s software rather than the software itself, forcing each life sciences company to conduct a
complete FDA software validation process. The software, documentation and services provided in the FDA
Validation Toolkit for PolicyTech can help reduce the time and effort required by capturing as much of the
standard information as possible from each manufacturer.
Manufacturers who must meet and achieve 21 CFR Part 11 and 820 compliance, including producers of
pharmaceuticals; diagnostic substance; biological products; surgical and medical instruments; orthopedic,
prosthetics and surgical appliances; dental equipment and supplies; and ophthalmic supplies can benefit
from the FDA Validation Toolkit for PolicyTech. Companies must demonstrate that they can meet the
processing, safety and tracking standards required by law.
End-to-end validation can be achieved by utilizing the resources contained in this Toolkit – from establishing
scope and developing user requirement specifications, to devising a validation master plan and running
test scripts.
These resources are designed to allow “continuous validation” for companies doing business in a regulatory
environment by making validation of software upgrades and implementations easier, faster and more
cost effective.
To help expedite your FDA software validation process, the FDA Validation Toolkit for PolicyTech includes:
Introduction to Validation
The introduction summarizes the documentation and 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 PolicyTech.
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Certification Memo to the FDA
This template 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 to help you
meet this requirement.
Risk Management Plan
Within the Toolkit, we have included a sample risk management analysis and plan created to
clarify potential risks, determine the level of risk and create response plans to mitigate these risks.
Requirements Documentation
Key documents required for business and regulatory reasons, including the following:
»» 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 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 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 guides you through the process of demonstrating that the software meets
all technical specifications, is installed correctly and that 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.
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