CTG Drives Efficiencies for Global Pharmaceutical Leader for More Than 25 Years
Throughout its 50-year history, CTG has consistently delivered world-class quality and reliability in IT services and solutions. The company is proud to work with countless leading brands across a wide range of industries, helping them overcome challenges spanning application services, quality assurance testing, regulatory compliance, staffing, and beyond.
In 1991, CTG began working with one of the world’s leading pharmaceutical manufacturers. Founded over a century ago, the company has grown from a small Midwestern brand to a global pharmaceutical powerhouse, with a company culture focused on research and quality. The provider selected CTG based on its extensive experience in health and life sciences, as well as its reputation for delivering reliable, consistent support across a range of functionality, including legacy application support and quality management.
Computer System Validation
One of the first areas of focus for the CTG team was Computer System Validation (CSV). Initially, client needs in this area centered on basic staff augmentation and consulting services and CTG provided expertise in the form of validation strategies, coordinators, documentation specialists, and test leads and analysts. Over the past ten years, CTG’s work in this area has matured greatly, successfully progressing to meet the industry’s changing regulatory landscape as well as evolving client needs.
As the regulatory emphasis grew, so did the client’s demand for CSV expertise, and CTG’s offerings evolved to focus on developing innovative solutions such as deliverable-based capabilities and risk-based approaches to CSV. Ultimately, as demand peaked around ITs busiest period ever, CTG helped the client establish a Validation and Testing Center of Excellence that provisioned services to many client projects and organizations under a single governance structure. The CTG team created metrics to measure and track quality and performance and created service level agreements to guide processes. CTG also brought expertise from Europe and provided testing methodology enhancements out of its proprietary STBox (Software Testing Based on Experience) Methodology.
In addition to supporting CSV needs, CTG also assisted the client across a range of other functions, including drug research and development. Requirements in this realm differ from traditional IT needs, and there is often not a ready market of commercial, off-the-shelf systems available to solve the specific, individual requirements of each organization.
To address this challenge, CTG used a hybrid development model, incorporating elements of traditional and Agile development methodologies to produce unique solutions critical for furthering the client’s R&D processes. Over the course of 7 years, the CTG team has successfully developed more than 60 discrete solutions designed to aid product development. A typical solution takes approximately 60-90 days to deliver, and the team is generally working on two to three solutions simultaneously. Using this approach, the CTG team has been able to maintain customer focus and effectively prioritize development needs while delivering consistent value, a feat that other vendors have been unable to match. In this manner, CTG has delivered a wide range of solutions at a rate and level of quality that other providers cannot. Solutions span the areas of vendor management, inventory control, video monitoring, data analysis tools, customer surveys, work order management, and beyond.
Over a two-year period the CTG team drove numerous product research and development efforts for the client, with consulting projects focused on areas such as overall program management, software architecture assessments, integration testing, metrics reporting, and beyond.
In the mid 2000s, CTG’s work with the client extended further into the client’s toxicology area where the CTG team executed a large-scale data migration and retirement effort that involved retiring approximately ten VAX-based systems and converting/migrating the data into a long-term platform independent repository. The project integrated data from legacy archives into the Electronic Data Archive system; the data remained accessible to the scientific community as well as the FDA.
Following the successful completion of the migration, CTG’s Data Migration Project (DaMP) was recognized for the achievement with a 2006 Regional Solution Achievement Award in North America. The DaMP project was singled out for this award because it provided an innovative, long-term solution for data archival needs across all business units. Additionally, the project met or exceeded all of its business justifications, and came in on time and under budget.
Following this success, the client commissioned CTG’s support on a second endeavor in the toxicology space: creating a solution for deliverable-based system requirements for data-retaining and non-data retaining systems. The design included validation package retirement and conversion to Good Research Practices as well as post-retirement reviews. Many of the systems that were retired were lab systems or a data warehouse for research data. These enhancements enabled scientists to streamline documentation writing processes and spend more time in the lab.
CTG’s strong results in the areas of quality management and solution development led to other engagements across the client’s organization. Beginning in the late 2000s and continuing today, CTG extended its services to the area of Clinical Trials Materials Management, where team members spearheaded initiatives related to requirement and design review, quality assurance of site material and web content, development and review of test scenarios, development and review/execution of test cases, development and review of test summary reports, and migration of studies into production.
Today, results of CTG initiatives are now are more service than solution-driven. Our key deliverables are on-time delivery and no auditable findings due to testing. To achieve this, testing is completed on time so that FPV (first patient visit) is not affected and our testing documentation follows our test strategy so that no reportable findings are noted in audits.
Improving Underlying Processes
While the client’s focus remains on research and development and managing a robust pipeline of new drug candidates, focus must also be given to running and maintaining core business functions. CTG has delivered support across many business areas for the majority of its quarter-century engagement with the client. Specifically, the team assisted Global Marketing Applications and Corporate Affairs (GMACA) in providing web development services, basic desktop support, new applications development, development and support, and ongoing application maintenance efforts.
For Manufacturing Information and Control Systems (MI&CS), CTG delivered primary support for several systems. One such project was the transition from a paper workbook manufacturing system to a computer-based manufacturing system for the Parenteral team, who had never before used testing software. CTG’s Testing team was brought on to help with the installation of HP Quality Center (QC); set up of the project in QC; training the team on QC policy and use; authoring and executing test scripts; and managing defects. The Validation team was also brought in to work with design specifications; Release Description Documents/Test Summary Reports; Business Continuity, Disaster Recovery, and Security Plans; System and Document Periodic Reviews; and Change Requests. The Validation team also provided consultation and assisted in the development of all Computer System Validation documents, including routing design specifications for approval before the testing process could begin, and test summary documentation when testing was complete. Once the software was released, CTG began maintenance of the system in the four core areas: Diabetes Care, Diversified Health Care, Packaging and Devices, and Dispensing. The CTG team now focuses on maintaining the system in a validated state, as well as development and deployment for new business areas and products.
To date, CTG has provided our client with expert CSV consulting and solutions, more than 60 solutions to aid in product development, an award-winning data migration and retirement effort, Clinical Trials Materials Management, and process improvement. Moving forward, CTG continues to provide our client with reliable, value-add IT services that meet their evolving industry and regulatory needs.