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October - December 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.

Know, understand, and document your intended uses of the tool. 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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Emma Barsky Len Grunbaum

Quantifying Quality for GxP Compliance

by Emma Barsky and Len Grunbaum
Regulatory Compliance and Operational Consultants

Reprinted with permission from www.gxpperspectives.com.

GxP professionals understand the need for quality and quality systems and we discuss quality with one another on a daily basis. But how do we measure it? How do we quantify our results? Once again we turn to Len Grunbaum and Emma Barsky, regular contributors to GxP Perspectives, for their insights on how to quantify quality for the development manufacture, and distribution of health products such as drugs, medical devices, and biologics.

In its simplest form, the definition of "quality" is "how good something is." But what exactly does this mean for the life science industry, whose frame of reference is defined by regulations which are often vague and provide little or no guidance regarding how they should be implemented?

In light of this, we would like to offer some ideas regarding how to measure - quantify - how good your "quality" is in tangible and practical terms. We contend that such metrics are useful in order for company management to make sound decisions regarding whether and/or where the quality system (i.e., the operational infrastructure that promotes and facilitates "quality") requires improvement. The following key indicators are not all-inclusive (nor are the items mutually exclusive), but they provide meaningful ways to assess your "quality."

For example, consider the number of successful external and internal audits as a percentage of the total number of external and internal audits: the higher the percentage of successful external audits (e.g., by existing/potential clients, regulators), especially when you have a large number of them, the better your "quality." Passing one audit with flying colors is great but passing multiple audits with few minor or no observations is way better. It not only sets a trend regarding "legitimate" quality but it also validates the company's degree of quality from different perspectives. This scenario allows any company to claim that its quality system has withstood scrutiny from a variety of companies and/or regulatory agencies over a long period of time.

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