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August 2012


Janis Olson

Can You Use Automated Testing Tools as an FDA-Regulated Company?

by Janis Olson
Vice President of Quality and Regulatory Services, EduQuest, Inc.

Software test tools help development and testing teams verify functionality, ensure both the reliability and security of the software they develop, and investigate software bugs. Off-the-shelf tools are available for all stages of software development. Examples include static code analyzers, record and replay, regression testing, and bug tracking. Some software testing tool vendors offer an integrated suite that starts with the gathering of requirements and continues through software development and testing throughout the life of a project, including supporting the live system. Other vendors concentrate on a single part of the application development life cycle, such as just testing.

How do you use a tool so that the FDA will accept it?

You only get what you want if you know what your requirements are for using the tool. Understand the native functionality of the tool when used "as is" and what needs to be configured or customized to get the performance you need. Document the tool's configurations and customizations. Review the native functions and the configurations and map them back to your intended uses to assure that you have covered all your needs.

Use code you have already tested or verified using other means. Document your testing with test cases or scripts. Document the results, including the objective evidence of the actual results that can be compared to the expected results. Do not just record that the tool worked "as expected" or "passed." Use good and poor code to test your tool. Keep those pieces of code as part of the test documentation. Do fault insertion to assure that the tool behaves properly in all the expected scenarios. Do testing in the context of your use. Understand the tool's limitations. Each tool will solve problems but also create potential issues. You must know what these are.

Once you have mapped your intended use requirements to the tool's native functions and any special configurations and/or customizations, and then documented your testing—including the objective evidence of the results—you have validated the tool for its intended uses. Now you can use it.

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Cindy Fazzi

Contract Management: What's Compliance Got to Do with it?

by Cindy Fazzi
Marketing Communications Specialist, MasterControl, Inc.

Contracts are typically the purview of the finance and legal departments. But in regulated environments, the regulatory, quality, and other departments might also be involved in the contract management process.

Depending on the size of a company, the nature of its business, and the regulations and standards it complies with, an organization may be managing different types of contracts, such as quality agreements, supplier agreements, specifications agreement, services contract, IP licensing contracts, nondisclosure contracts, confidentiality agreements, and co-development and co-marketing agreements.

Contract management in regulated environments is different because its objective is twofold: business and regulatory. For example, an American pharmaceutical company that has a supplier contract with a foreign company to buy an API may have the business goal of buying the API at a reasonable cost (the purview of the procurement department), but the contract also must address the supplier's compliance with U.S. cGMPs (the purview of the quality/compliance team). So, even if the supplier's price is the most competitive, if a supplier audit shows serious cGMP deviations, the pharmaceutical company may choose not to renew the contract, or even terminate it.

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MEDTEC Ireland
October 10-11, 2012, Cork, Ireland

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Did you know that the FDA released a draft guidance this month regarding 510(k)s? "The purpose of this document is to explain the procedures and criteria FDA intends to use in assessing whether a 510(k) submission meets a minimum threshold of acceptability and should be accepted for substantive review. You should submit comments and suggestions regarding this draft document within 45 days of publication in the Federal Register of the notice announcing the availability of the draft guidance."
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