As organizations strive to achieve quality maturity, achieve harmonized systems, and become leaders, computer system validation will play an unseen but integral role. Traditional Validation processes present challenges since they extend project timelines and costs, impacting TTM and resulting in the inability of Life Sciences organizations to deploy new versions of the software. Specifically, the needed relationship between requirements and tests depends mainly on diligence and expertise that is often personally held. In addition, software manual testing requires a vast amount of time and resources and is monotonous work that drives neither the worker nor the company forward.

Harmonizing systems and tools and maintaining sustainability is crucial for achieving a validated, state-of-the-art eQMS. However, this journey is complex, and organizations must overcome several key barriers to harmonization.

Barriers to Harmonization

The first of these barriers is the regulatory environment. Systems must constantly change to keep up with ever-adjusting and expanding regulatory guidelines. These changes are not localized, and organizations must adhere to any changes made globally and with each of the corresponding global regulatory bodies. In addition to the regulatory hurdles, the software constantly changes, as do the modules and functionality. Finally, there is the need to be in constant audit readiness. Additional barriers to harmonization are substandard quality or human error, operational inefficiencies, and competing priorities or resources.

Beyond Harmonization, Leading with Automated Computer Systems Validation

Some companies go beyond harmonization to achieve a leadership eQMS position driven by sustainability and continual improvement while reducing risk without extra people, time, or money. Automated Validation Script Authoring or Automated Computer Systems Validation is critical to reaching this rarefied level. ACSV enables you to streamline and manage the validation process instead of executing tedious scripts, adapting to change more efficiently and with increased accuracy while reducing risk. ACSV increases regulatory rigor while reducing timelines and human error, allowing organizations to deploy new solutions and stay up to speed with rapid technological changes.

An advancement in Automated Script Validation is Automated Validation Script Authoring, which automatically generates PQ scripts directly from user requirements.

At its foundation, Automated Validation Script Authoring relies on the ability to streamline the definition and documentation of functional requirements, defined in terms of the following:

• A visual Workflow definition to describe a business process where each block in the workflow diagram represents a Task
• A Form definition for each task in the Workflow describing the list of data elements that need to be entered when performing the Task
• Description of the Team (set of personas participating in the business process), including the Roles required to perform each task
• Description of Policies that determine conditional execution of the workflows

Similarly, user requirements that surface during the software implementation are captured as changes over functional requirements and automatically analyzed by the Script Authoring engine to compile an exhaustive series of workflow paths by exercising all discovered conditions to enforce that the script visits each task in the Workflow.

Functional and user requirements become the basis for validation scripts, which are ultimately generated using pre-defined validation templates that enforce validation standards and best practices.

Key Benefits of Automated Validation Script Authoring

• Robust, reliable, and consistent approach
• Improved efficiency in authoring validation scripts: availability and access to the finished product is not required to undertake the script authoring process
• Improved quality of the authored scripts: scripts driven directly from requirements cannot omit scenarios or assert the wrong expected results
• Improved overall validation methodology: scripts test the requirements, not the implementation of such requirements (based on a potentially wrong interpretation by the implementation team)
• Improved quality and efficiency of script execution and summary reports: automated execution removes human errors and the need to have experienced personnel with knowledge of the system executing scripts
• Improved efficiency of the very implementation: the implementation team can verify that the implementation satisfies the requirements before even delivering the implementation to the validation team for formal execution (test-driven development), reducing loops between developers and testers
• Automatically generates PQ Validation scripts directly from customer-specific requirements captured during the implementation of the SmartSolve Quality Modules.

To learn more about IQVIA’s eQMS solutions and deployment models, visit SmartSolve® Enterprise Quality Management System - eQMS Software - IQVIA, or check out the full webinar here.