Justin L. Smith, Director of Product Management, Pilgrim Quality Solutions, an IQVIA company
Within regulated environments, such as the Life Sciences community, there are a number of top-of-mind business challenges. Key among them is to increase operational efficiencies while keeping pace with an ever-evolving regulatory landscape. A daunting challenge to say the least, mainly due to the “ever-evolving” factor.
To address the challenge, companies invest in fantastic new systems and software that provide the foundation for compliance while also affording significant efficiencies over their paper or manual processes. However, too often, companies get stuck on their initial version of software due to the cumbersome impact that computer system validation has on the upgrade process.
Gain Productivity with Automated Computer System Validation
As with most difficult business challenges, innovation can often provide the best answers. Although automated testing techniques have been used by the software industry for decades, it is only in more recent years that automated computer system validation has become a viable option for regulated environments. Automated validation solutions offer significant productivity gains by minimizing the need for human resources and shortening the timeframe required to validate software systems. This also increases overall quality since the degree of testing can be exponentially greater.
“Software validation is an important consideration at Life Sciences companies. The time and cost of validation can cause version lock, delay time to value, and reduce agility.”
– Dan Jacob, Research Analyst, LNS Research
There are vendors on the market whose main service is to build custom solutions that automate the system validation process for companies. Other software vendors are integrating and packaging out-of-the-box automated validation tools with their software. Bundled validation services provide more immediate benefits because they don’t require a lengthy upfront build-out process.
A Viable Solution for Automated Validation
What makes an automated validation solution viable? There are a few key components:
1. Validation Test Cases
As with manual validation, the first piece involves documenting the specific test cases that need to be validated. These test cases must clearly define the actions to be taken and the expected outcomes from those actions. In other words, when the user clicks on x, the system should output y. Vendors that provide pre-authored validation test scripts as part of their software package offer the most benefit to companies looking to optimize the system validation process.
2. Automated Testing Engine
The second key ingredient to a viable automated validation solution is the engine that conducts the automated testing. Some automated solutions are based on record-and-playback technology that involves recording a person manually executing a test script in the system so that it can be played back at any point in the future. Record-and-playback solutions streamline the overall validation process, but ultimately still rely on a human to initially conduct each test at least once. Further, any time a change is made to the system, such as the addition of new functions in an upgrade, a re-recording is required.
More effective automation involves engines that can read and interpret the documented scripts to execute the test cases against the system in real time. The efficiency gains from this type of solution are immeasurable, since there is no need for a human to ever execute the test cases. In addition, when changes are made to the system, the engine can automatically re-execute the affected test cases. Pilgrim Quality Solutions’ Automated Validation can be used for full regression and can run an unlimited amount of times with no need for manual intervention.
3. Objective Evidence
The final key component to a solid automated validation solution has to do with the objective evidence that is produced as a result of the validation tests. A good automation engine will execute the test cases by emulating human interactions with the system, allowing the tests to be visible. Visibility not only allows the tests to be witnessed in real time, but also allows the engine to take screenshots of the test results so that objective evidence can be captured, comparing the expected outcome documented in the test script with the actual outcome captured in the screenshot.
“Pilgrim’s Automated Validation solution is a fresh and compelling solution to this challenge, as it automatically validates the entire solution through the user interface including all user interface rules. These approaches reduce validation effort, cost, and time, which we expect will result in more frequent software updates, increased efficiency and productivity.”
– Dan Jacob, Research Analyst, LNS Research
Some solutions even offer an option to produce a video recording of the entire test from end-to-end. A comprehensive automated validation tool will automatically produce comprehensive objective evidence artifacts as an outcome of the validation process.
When evaluating your business and the benefits of staying on current versions of your software, consider how you can leverage automated validation solutions to help ensure regular upgrades.
Learn More About Automated Computer System Validation
Pilgrim’s SmartSolve® Automated Validation services deliver operational qualification (OQ) validation execution of SmartSolve quality management solutions on a reduced timeline, enabling your team to focus on what they do best—managing quality processes and producing high quality products.
Automated Computer System Validation
The Key to Quickly Improving Your Quality System
Learn the benefits of automated validation as well as the key components of automated validation software.