Software validation is essential for regulated industries subject to GMP (good manufacturing practices) or GxP (good pharmaceutical practices) guidelines. As required by the FDA (Food and Drug Administration), meeting regulatory compliance requires the validation of software utilized for designing, manufacturing, packaging, labeling, servicing, and storing every device or product made for human use.

Demonstrating software will reliably carry its functions will not be adequate. Validation also involves software infrastructure, and knowing how a solution will interact with other systems throughout a workflow is necessary. This will determine whether the software meets regulatory standards for its intended functions.

As the software environment landscape may include in-house, out-of-the-box, and third-party tailored solutions, validation can be an extremely complex task. As required by the FDA, software validation must show through objective evidence that a particular process will generate the result expected with consistency to ensure workflows run properly.

During the past few years, industries have been increasingly transitioning to paperless data management and handling to help ensure data integrity. Every document required by cGMP (current good manufacturing practices) can be inspected by the FDA inspection. Thus, every program generating or interacting with GMP data requires validation. In addition, the FDA has recommended the implementation of effective and meaningful strategies for the management of data integrity risks. These strategies must then consider the design, operation, and monitoring of controls and systems as determined by the risks to patients, processes, and products. In this complex environment, LIMS customers should beware of vendors promoting pre-validated software.

There are several important benefits from software validation. The reliability and usability of end products are both increased. This results in the reduction of failure rates, recalls, and corrective actions. Thus, there are reduced risks to consumers and patients.

Part 2 will cover the STARLIMS Automated Validation Framework and Testing Kit.

STARLIMS Integrated Solution

Implementing state-of-the-art technology, STARLIMS provides a totally integrated solution that incorporates LIMS, Electronic Laboratory Notebook (ELN), Scientific Data Management System (SDMS), Advanced Analytics, and Mobile within a single application. This innovation makes building and maintaining custom interfaces required by third-party tools unnecessary.

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.