In the absence of a unified qualification and validation system, maintaining and managing thousands of templates across 19 sites in multiple countries was extremely challenging for pharma giant Roche and its subsidiary Genentech. Every site operated with a different set of legacy templates, and paper documents (e.g., protocols, reports, specifications) were scattered across local and global repositories.
Without a standardized system, it was difficult to review and approve templates in a timely manner and cumbersome to update and revise them companywide. Highly skilled employees spent hours “reinventing the wheel” every time they had to create a new document. Hunting down the required records for audits and inspections was equally time-consuming. The onset of Covid-19 made these problems even more acute.
Transformational Benefits Achieved
To address these challenges and bring harmonization to its corporate validation processes, Roche/Genentech implemented the ValGenesis VLMS. The system, known internally as eVALRoche, satisfies the wish list of transformational benefits the company hoped to gain with a paperless solution such as:
- 50% or more reduction in validation cycle time
- 40–50% reduction in time to market
- 40–50% reduction in cost
- Enables remote audits
- Uninterrupted validation
- Data-centric validation
- Audit-proof validation
Roche/Genentech deployed the solution in three phases over one year. Initially used for cleaning and process validation, the company expanded its scope to include computer system validation (CSV). Much more than a document management system, eVALRoche is used for scheduling and dispatching tasks; authoring, reviewing, and approving documents; test execution; and storing documents.
“If you look at it from a nutshell perspective, eVALRoche is a one-stop shop for everything from the scheduling of the tasks to archiving approved documents,” said IT Product Manager Sathish Kumar Shanmugam.
Increased Innovation and Faster Time to Market
The centralized platform streamlines workflows and increases efficiency. A side-by-side comparison of before and after workstreams shows that the company has eliminated 50% of the non-value-added, productivity-killing tasks employees were forced to perform in the paper-based system. These efficiency gains have allowed Roche/Genentech to reallocate resources to prioritize innovation and get products to market sooner with less effort, passing on the savings to patients.
“It’s not about eliminating people; it’s about reallocating resources to put back into innovation,” said Genentech Business Application Manager Shawn Phillips. “The cost savings are given to the patients by being able to produce the product in half the time.”
Shanmugam credits the system’s unique bind-as-link functionality for being the game changer. Bind-as-link functionality allows users to associate relevant templates to various sites within the organization. To enforce standardization, eVALRoche only allows templates to be revised/updated at the global site level. The subsequent child templates are automatically revised/updated by the system, saving employees hours of repetitive work.
“Enabling the bind functionality and global template management has helped us make tremendous strides toward standardization and harmonization,” said Shanmugam. “From a statistical point of view, it has reduced the overall authoring time of deliverables by around 30–70%.”
Looking Ahead
Roche/Genentech, Phillips admits, has just started to scratch the surface of all the ValGenesis VLMS can do. User adoption has been good, and confidence in the system continues to grow.
“We saw the benefits almost overnight,” said Philips. “As we continue to integrate legacy documentation into the system, we’re seeing more and more benefits.”
About the Keynote Speakers
Shawn Phillips, business application manager at Genentech, a Roche subsidiary, has over 25 years of pharma and biotech industry experience. Read Shawn’s LinkedIn Profile.
Sathish Kumar Shanmugam, IT product manager at Roche, has over 15 years of software, pharma, and biotech industry experience working in Europe, Asia, and The Americas. Read Sathish’s LinkedIn Profile.
