Roche Diagnostics uses Validation Manager to standardize validation and verification across Managed Laboratory Services
About Roche Diagnostics
Roche Diagnostics delivers Managed Laboratory Services (MLS) as a comprehensive, end-to-end solution, managing diagnostic infrastructure across laboratories, including both Roche and third-party equipment.
From full laboratory refreshes to new assay onboarding and system upgrades, Roche supports laboratories across environments ranging from single hospitals to large, multi-site pathology networks.
This integrated approach helps laboratories streamline validation and verification while meeting rigorous standards such as ISO 15189 and INAB requirements, the Irish equivalent of accreditation bodies such as UKAS (UK) and DAkkS (Germany).
1 Goal
Creating one standardized approach
to validation and verification
As managed laboratory service contracts became more complex, Roche saw growing demand from laboratories for more support with validation, verification, coordination and project management.
Traditionally, validation and verification work could involve Excel spreadsheets, manual data transfer, different supplier formats, separate reports and limited long-term traceability. This made it difficult to create one consistent approach across multiple sites, departments, suppliers and instrument generations.
Roche wanted a solution that could:
- Standardize validation and verification across Roche and third-party systems
- Reduce manual data handling and spreadsheet-based work
- Give laboratories, Roche teams and partners one shared view of progress
- Support multi-site and multi-discipline laboratory networks
- Build a reusable repository of studies, reports and historical performance data
- Help laboratories move from manual reporting to digital oversight
2 Solution
Using Validation Manager as
the central validation engine
Roche introduced Ascentry Validation Manager into its managed laboratory service model as a shared, digital platform for validation and verification.
Validation Manager gives laboratories a single standardized environment for building protocols, creating studies, importing instrument data, reviewing results, generating reports and managing sign-off. For Roche, it also creates visibility across the process, helping applications, technical, customer account and third-party teams support laboratories more effectively.
From a technical perspective, Validation Manager helps Roche and its customers automate data input, reduce manual calculations, identify outstanding assays quickly and generate reports from structured study protocols. Once a study is built and validated, it can be duplicated, adapted and reused across similar instruments, assays, departments or sites.
From a managerial perspective, Validation Manager gives all stakeholders shared visibility and standardized oversight across the validation process. Laboratories remain the custodians of their own data and quality policy, while Roche and external partners can support the process with greater transparency, consistency and speed.
Roche has also started combining Validation Manager with specialist external support, such as validation and data science partners, to help laboratories overcome resource constraints. This allows laboratory scientists to focus more on instrument familiarization, training, troubleshooting and scientific review, while structured data handling and analysis can be managed more efficiently.
3 Result
Faster validation, fewer manual steps and stronger partnership with laboratories
With Validation Manager, Roche has significantly improved the speed, consistency, and transparency of validation and verification across its Managed Laboratory Service contracts.
By digitizing and automating validation workflows, Roche and its laboratory partners have reduced time spent on validation preparation and statistical analysis by approximately 40–50%. The automation of data entry, calculations, and reporting has minimized manual steps and reduced the need for documentation corrections, allowing teams to focus on data interpretation and corrective actions rather than data handling.
Validation Manager has also accelerated laboratory go-live timelines. With structured protocols, automated reporting, and clear visibility of outstanding assays, laboratories can identify and resolve issues more quickly—reducing time-to-clinical-use by several weeks in large-scale deployments.
The platform has improved project coordination and visibility across stakeholders. Validation progress can now be monitored in real time, eliminating the need for manual updates and reducing reliance on fragmented communication. This has strengthened collaboration between Roche teams, laboratory staff, and external partners, creating a more transparent, partnership-driven approach.
In addition, Validation Manager supports compliance and audit readiness by providing a clear, digital audit trail and standardized documentation aligned with accreditation requirements. This has increased confidence in validation outcomes while simplifying regulatory processes.
Operationally, Roche has been able to standardize validation practices across sites by developing reusable “gold standard” templates that can be deployed across laboratory networks. This ensures consistency in quality and enables faster, more scalable implementations across multi-site environments.
4 Key outcomes
-
40–50% reduction in validation workload
Reduced time spent on validation preparation, data handling, and statistical calculations. -
Faster go-live timelines
Reduced time-to-clinical-use by several weeks through automated reporting and improved visibility of validation progress. -
Fewer manual steps and errors
Automation of data entry and calculations has significantly reduced manual intervention and documentation corrections. -
Improved visibility and coordination
Real-time tracking of validation progress enables better project management and reduces reliance on manual updates and email chains. -
Standardized validation across sites
Creation of reusable “gold standard” templates ensures consistent validation practices across multi-site laboratory networks. -
Reduced administrative burden
Simplified report generation and documentation processes free up laboratory staff to focus on higher-value tasks. -
Stronger collaboration and partnership
Full visibility of the validation process fosters a more collaborative, transparent relationship between Roche, laboratories, and partners. -
Enhanced compliance and audit readiness
A clear digital audit trail supports regulatory traceability and simplifies accreditation processes.
