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.
How It Works
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.
Who Needs It
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.
Get a Head Start on Standard Industry Best Practices
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.
- 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.
About NAVEX Global, Inc.
NAVEX Global’s comprehensive suite of ethics and compliance software, content and services helps organizations protect their people, reputation and bottom line. Trusted by 95 of the FORTUNE 100 and more than 13,000 clients, our solutions are informed by the largest ethics and compliance community in the world.