Global Computer System Validation

Engineering is excited to be working with a leading medical device company to support their global Computer System Validation (CSV) business needs for the deployment of a new software system. Engineering’s industry expertise and background delivering Computer System Validation services to the manufacturing sector is being leveraged to plan a corporate-wide, risk-based validation program.

The scope of the project includes the design of validation scripts and the execution of these scripts to multiple production sites across the world using HP-ALM software. Our team of consultants will be providing CSV for a project focused on the installation of a highly-rated Statistical Process Control (SPC) solution to several of the customer’s manufacturing sites as well as its direct integration with already existing systems like JDEdwards, LiveLink, CMMs, TIBCO and User Access.

Computer System Validation

Computer System Validation (CSV) is a required and important activity for the Life Sciences manufacturing business across the world. In an industry highly regulated by the Food and Drug Administration (FDA), European Medicines Agency (EMA) and other international regulatory bodies, CSV works to maintain a consistent quality in all currently produced goods and provides a baseline for assuring quality in the manufacturing of new and updated products into the market. In addition to helping meet the requirements of validation set by related regulatory groups, CSV also provides a heightened base quality of the validated solution. By validating a computer system during earlier stages of development, a business is able to detect potential deviations from the listed requirements and correct them earlier in the process, avoiding detections that are more costly and time-consuming to resolve during later stages. Businesses that regularly validate new and updated solutions benefit from faster, more efficient systems, which in turn improve product quality for customers, encounter errors less often, and are maintained more easily and with lower costs incurred.

Challenges

There are several challenges that Engineering is tasked to address for this enterprise CSV initiative, including:

• Creating a validation plan that is effective for a highly customized solution, taking into account multiple system interface points and site-specific requirements.
• A strict deadline for completion, targeted for the rollout of the new SPC system into production. Whereas validation efforts generally extend to 33% of the timeline past the analysis and configuration phase for a solution, the urgency of this project left as little as 16% of the timeline available for pure validation tasks.
• Taking into account the separate lists of intended uses for the new solution presented by each site targeted for validation, including varying requirements of the system which often differ and occasionally conflict with the expectations of other sites.

Engineering's Approach

Recognizing the high level of expertise and skills necessary to fulfill all validation requirements and at the same time meet the challenges presented by the current project conditions, the customer chose Engineering to lead their initiative.

As we do with every customer and on any project, Engineering is leveraging our unique, hands-on, collaborative consulting approach in order to ensure a successful validation program and results. Engineering is in constant and direct communication in three directions:

• Engineering’s validation team coordinated heavily with the software configuration team in order to detect early configuration issues and provide constant feedback during the validation design process.
• Engineering organized continuous discussions with the customer and related parties in order to most effectively gather and organize requirements and minimize downtime caused by review and approval tasks.
• Engineering maintained contact with the software system vendor to accelerate validation design and resolve configuration errors discovered during the validation execution process.

Engineering's Advantage

By maintaining a continuous, high level of communication with all stakeholders to keep timelines in tack and efforts aligned, our team is able to execute quickly and efficiently.

Engineering first gathered all the requirements for the target system, then grouped the requirements between those that were site-specific and those that were global, applying across all the sites and only needing to be validated once. Our consultants work closely with the SPC software vendor to ensure that validation scripts were well prepared to cover basic installation and functionalities, reducing the design time significantly. Our validation team’s coordination with the configuration team allows us to use the Hyla Unique Validation Strategy, a “staggered” approach to validation of specific configurations that involves performing required execution tasks for one configuration package as the following package begins its own configuration and finalization process.

Using the above-mentioned techniques, combined with our design philosophy and collaborative approach, Engineering is able to fully and effectively validate the target system for all required sites while maintaining the strict deadlines.

As a result of Engineering’s singular validation techniques and approach, our client has already reaped the benefits of a more efficient and cost-effective CSV procedure. In addition, our validation has covered multiple sites, easing the process of communication and analysis of data between sites using the universally validated software. The benefits of Computer System Validation have been made apparent almost immediately and far beyond merely meeting FDA requirements. As the project progresses, the projected business and IT conveniences provided by CSV have been set to continuously grow.

Contact Engineering today to learn how our world-class team can support your Computer System Validation needs:

• System Risk Assessments for Validation
• Validation Plans
• Risk-Based Validation
• Requirements Tracking
• Validation Scripts Design
• Validation Execution Support (IQ, OQ, PQ)
• Help Build out your Computer System Validation Practice
• Validation Change Management
• Support Validation Efforts to keep you FDA-Compliant
• Support Leveraging GAMP 5 in your Validation Processes