Test Management Tools - What Are They & Why You Need Them

Written by Kim Stanton, Associate Validation Manager at QPharma

As anyone that has been involved in a Validation effort can attest to, the old Validation Standards of requirements/system design documentation, over-testing, paper based script development and execution can be burdensome, resource/budget intensive and time consuming. This is making Pharmaceutical, Biopharmaceutical and Medical Device companies search for Test Management Tools that will streamline their validation efforts.

Computer System Validation (CSV) Test Management Tools manage the validation process by providing the ability to gather requirements, conduct risk assessments, create test plans, execute scripts manually or automatically, manage deviations and create summary reports.

Since many Test Management Tools are web-based they have the ability to centralize a company’s validation processes, allowing for resources from various locations to be involved in all aspects of validation efforts without the need for travel budgets and travel resource downtime. Execution times are greatly reduced since testers do not have to transcribe pages of test results, attachments and deviations. Also, multiple testers can execute simultaneously (unless there are script dependencies) since all activities are performed in the Test Management Tool. In addition to streamlining the execution process, the following steps are greatly improved using Test Management Tools: traceability of requirements to testing, attachments to test steps and deviation to test steps.

No matter which Test Management Tools are used to manage a company’s validation processes there could be a number of issues that will need to be addressed during the implementation of a Test Tool. Moving from a paper-based test management process to a system-based process requires changes in current procedures and resource training.

Many Test Management Tools have the ability to configure Workflows. Workflows are critical for controlling the validation process, from requirements documentation to summary report close out. Workflows ensure consistency for each validation effort managed by the Test Management tool no matter what type of application is being validated, what department of the company is conducting the validation, or what location of the company is performing the validation. A controlled workflow ensures compliance with the companies Standard Operating Procedures (SOPs) and regulatory guidelines. If workflow configuration is not available in the chosen Test Management Tool, a SOP for workflow management/operation must be documented and approved.

The Test Management Tools selected should be compliant with 21 CFR Part 11 requirements, which includes:

• The Test Tool must only be accessible by personnel with a valid user account.

• A well defined Approval process (see above) must be implemented.

• Electronic signatures should be configured.

• Audit trails to capture creation and changes to all validation deliverables including the executed scripts must be implemented.

All personnel involved in Validation processes must be educated and trained on the Test Management Tool to include Quality Assurance personnel. This will ensure that resources that perform validation activities will realize the benefits of the Tool, ensuring that it will be used in a compliant manner.

Since the Test Management Tool will be configured by both Regulatory and Business requirements, the System Development Life Cycle (SDLC) of the tool will need to be managed to include support, tool-specific SOP documentation and validation of the tool.

 

For more information on QPharma's validation services, please email us at info@qpharmacorp.com, or give us a call: 888-742-7620 and ask for Rob Finamore to discuss your needs!