Like many multinational life sciences companies, Philips Healthcare, a leader in intravascular diagnostic imaging and cardiovascular and endovascular therapies, wanted to harmonize its computer system validation efforts companywide. To accomplish this goal, the company needed a digital system that would unify 35 site-specific CSV processes into a single global CSV methodology.
Philips implemented the ValGenesis VLMS (Version 3.2) in 2016, then upgraded to Version 4.1 in 2021. In his session, “Philips: Our Journey with ValGenesis,” QMS Manager Paul Dacosta discussed why Philips selected ValGenesis and the history of collaboration between the two companies.
Philips’ Four “Whys” for Going Digital
According to Dacosta, the company’s drivers (or “whys”) for going digital were to:
#1: Increase efficiency: Philips wanted to reduce the long throughput times and rework associated with paper-based CSV. Introducing approval via electronic signatures and eliminating non-value-added activities would help them achieve this goal.
#2: Decrease cost: Philips estimated that an automated solution could reduce the time and cost of its validation efforts by 25%.
#3: Improve compliance: Without standardization, quality was highly dependent on personal experience and differed significantly from site to site. Document-to-document transfer of information via a digital system would improve overall accuracy and efficiency, ensure compliance with regulations, and prevent remediation action.
#4: Standardization: Philips needed a robust system that could standardize the validation process for its quality management software system across multiple geographies.
“Based on our whys, ValGenesis was our clear choice,” said Dacosta.
Implementation and Beyond
Implementing a critical system in a large global company comes with challenges. Philips and the ValGenesis team collaborated to overcome those challenges. For example, the requirements traceability matrix (RTM) is one of the key validation deliverables at Philips. It is executed at different phases of the validation project to confirm whether there is a trace between requirements and the test.
When the company began experiencing issues with the RTM, such as not being able to generate the end-to-end RTM report, Philips and ValGenesis business analysts collaborated on the development of a new RTM model. As a result, Philips was able to generate the end-to-end RTM report for entities with large volumes of data successfully while maintaining compliance with regulations.
ValGenesis by the Numbers
Since implementing the system, the use of the ValGenesis has skyrocketed. Dacosta shared the following examples:
Philips went from 221 active users in 2017 to 1,915 active users today.
The company has four dedicated ValGenesis subject matter experts/support team members based in the US and India.
218 applications and entities are stored in ValGenesis.
The company performed 1,528 validation executions in ValGenesis via change requests from 2019 to 2021.
Philips maintains 62,993 validation artifacts within ValGenesis.
When asked during the Q&A to provide an example of how working with ValGenesis is different from working with other vendors, Colleen McClenaghan, Philips' head of non-product system software (NPSS) validation process management replied, "In my experience, ValGenesis is unique in that they are willing to share their validation documentation with us. When we moved from our custom branch, 3.2, to our main branch, 4.1, we were able to learn our validation on the Philips side by reassessing and reviewing the functional requirements, specifications, and OQ that ValGenesis performs. Being able to use this vendor documentation shaved at least six weeks off our schedule; that was a tremendous help. We've had a long working relationship with ValGenesis, and they have really taken an interest in our success."
About Paul Dacosta
Paul Dacosta has seven years of experience working in the life sciences industry – five of those years as a validation engineer. He currently works as Philips’ QMS Manager, supporting the ValGenesis application as a subject matter expert.
Philips: Our Journey with ValGenesis
Philips implemented ValGenesis globally to support their standardized software validation process for quality management system software. Learn about their journey from a customized branch to the main branch in Version 4.1 and the challenges they overcame with end-to-end requirements traceability and split execution testing.
QMS Manager Philips
Philips needed a digital validation lifecycle management system that could standardize its paper-based computer system validation (CSV) efforts across multiple geographies.