As discussed in Part 1, meeting FDA regulatory compliance requires the validation of software utilized for designing, manufacturing, packaging, labeling, servicing, and storing every device or product made for human use. Part 2 will cover the STARLIMS Automated Validation Framework and Testing Kit.

STARLIMS Automated Validation Framework and Testing Kit (STARLIMS Kit)

Abbott Informatics has developed, tested, and released the STARLIMS Automated Validation Framework and Testing Kit to assist laboratories in meeting their software validation requirements as required by the FDA. This solution provides the benefits below.

• Major reduction of execution time
• Reliable production of objective evidence and results
• Increased efficiency by simplifying regression testing
• Capable of development to intended uses
• Significant decrease of human errors

A comprehensive suite, the Automated Validation Framework, and Testing Kit is utilized for verifying STARLIMS core software functionalities for every deployment and setting. A LIMS client receives a toolset with the features that will be needed by their validation processes as listed below.

1. Knowledgebase of core functionalities, use cases, and intended uses of STARLIMS.
   
2. Allowing flexibility, the STARLIMS Kit provides customers with several testing scenarios for specific STARLIMS applications or workflows. This allows a customer to focus on specific functionalities and applications, decreasing risk, increasing efficiency, and producing savings.
   
3. The STARLIMS Kit can also serve as an input for performing the Operational Qualification (OQ) of the STARLIMS software inside a deployed environment. OQ is a requirement of almost every validation task. It is a testing process ensuring a program is properly operating within the limits specified.
   
4. The STARLIMS Kit’s set of testing scenarios can be repurposed or reused for the creation of an OQ that’s specific to the software’s deployment.

STARLIMS customers should keep in mind that although Abbott Informatics products and services will provide their assistance and expertise, software validation will remain a collaborative effort. In addition, validation should not be carried out in isolation, but governed by a quality system (QS). Moreover, Abbott recommends that when customers carry out the software validation process, it should be overseen by a third party with expertise.

Alpha LIMS Implementation

Alpha has been involved with the implementation of over 50 LIMS systems ranging in size from small, “off-the-shelf” software systems to very large, highly customized, multi-functional systems, including STARLIMS, for both governmental agencies and private enterprises. For affordable client-focused network consulting services and solutions, please call Alpha today at (410) 295-9500.