Highly regulated industries need solutions they can trust and that make validation processes more efficient. Adding legitimacy to the cliché phrase, “Time is of the essence.”
In the world of pharmaceuticals and medical devices, C3i Solutions is innovative. The testing team took manual testing processes and found a way to maximize efficiency, turning hours-long tasks into minutes.
Repeating for emphasis: Hours to minutes.
C3i Solutions, now part of HCLTech, is a global company working in the life sciences medical device and pharmaceutical market with the responsibility of systems validation in the highly regulated space. Medical device and pharma companies are their primary customer base. Linda Doherty, Vice President of Global Process Excellence, has worked for C3i Solutions since 1999, seeing the company evolve from mergers and furthering their quest for progress in the world of validation. Historically C3i Solutions helped US call centers for pharma companies and then moved into clinical trial support. With growth, came Ron Hinkel, Director of ISQA/Validation, and he brought a wealth of knowledge of medical information and pharmacovigilance system validation.
Their challenges were manual processes, multi-systems, multi-screens, all managed by a small team. Ron’s team is the last team to touch the process prior to go-live. Managing schedules and trying to complete several validation processes in a timely manner, leaves very little room for error. The goal: Find a single solution that can automate testing procedures and eliminate manual labor, increase productivity and ultimately better serve their clients.
HCL DevOps Test does just that. The product automates the most labor-intensive tasks, such as screenshots and labeling of screenshots for testing documentation. “Our work is very cumbersome because of the documentation requirements of the regulated industry. It is very time consuming and labor intensive in terms of adding screenshots and evidence (of testing), whereas the tool does all of that for us automatically,” states Hinkel. Linda Doherty goes on to explain, “As part of a regulated industry, you must do periodic regression testing, which is never part of the project plan. Ron ensures we do what needs to be done. He schedules and completes these tasks in conjunction with enhancement requests testing and new client projects. It’s always a schedule-juggling act with him and his team to get all this testing in, so that is where HCL DevOps Test helps.”
C3i Solutions’ testing team has done their best to improve productivity over the years. “As of right now, I’d say we are tracking 50 to 60 individual projects with a small labor force. We divide and conquer, so that an average person’s workload is about four projects at the same time. We prioritize based on business needs, so anything we can do to improve our productivity allows us to deliver to our customers faster,” Hinkel explains. Their relationship with HCLSoftware has evolved over the years with a recent three-year renewal and a working dynamic with HCL’s internal team has been key. Naming their client advocacy point of contact, Senior Software Engineer - Jincy Jayaprakash, as “invaluable” in helping the team navigate technical implementation.
Measurable results of HCL DevOps Test’s successful implementation have been done with a side-by-side comparative study: their previous testing process vs the current operation with the product. They saw the entirety of a testing project go from 30 hours of manual labor to three to four hours with the tool with 25 minutes to execute. C3i Solutions has reported a 40-50% reduction in total validation cycle execution time.
The product also offers scalability. Doherty expands, “With the testing team now, if we did go down a resource naturally, the tool ensures we can keep our team stable and take on more work despite the loss. There’s a lot going on, a lot of continuous work, and this helps us to say, “Yes, we can actually do it.” And we are starting to be able to do it faster.” There is peace of mind that comes with being able to maintain business operations despite employee resource changes.
Use of the product improves our testing services. The implementation of HCL DevOps Test provides more screenshots than the team would normally capture and automates the capture of screenshots. The additional screen captures and improves the quality of documentation the C3i Solutions team is able to provide in audits. The automated report itself “presents extremely well” within an audit. The report generation used to take 4-8 hours to prepare, now it’s down to 0 minutes since HCL DevOps Test generates the results automatically.
With HCL DevOps Test, C3i Solutions is ready and available to serve their medical device and pharmaceutical clients taking the stress of testing and validation off their shoulders. The team is solid, proven, and operates to a degree of maximum efficiency that they’re always pushing to improve. HCL DevOps Test is the solution that has proven to automate and eliminate labor intensive practices, is scalable, and has a commitment to evolving with their customer and their innovative strategies. A product that can grow with you.
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