Validation
Management System
Transform the way you gather and analyze requirements as part of your validation strategy
Automatically generate test cases and scenarios
Create Smart Docs and Traceability Matrices and ensure quality
Get e-signatures and feedback on Work Items
Easy Access to Key
Validation Management Features
Online Reviews
Online Part 11 Compliant Reviews that bring teams together. Collaborate with your entire team in the same space with free-to-participate reviews.
Requirements Documents
Build requirements and documentation at the same time using an industry-recognized Smart Docs tool. Allow your team to build documentation directly within your Azure DevOps/TFS projects.
Trace Analysis
Report on your test coverage by creating Traceability Matrices that can be easily turned converted into Excel Documents. Identify orphaned requirements and build coverage quickly and easily.
One-Click Reports
Maintain auditability through the use of one-click reporting tools. Create difference reports that show the changes between two sets of work items, or review audit reports complete with timestamps.
E-signatures
Integrate electronic signatures with workflows to ensure compliance with all necessary regulations.
End-to-end implementation support
As an implementation partner ION Pharma supports your project from start to finish. Starting with reviewing and analyzing your current validation approach to understand what needs to be configured. Based on these insights duration and efforts of the full configuration can be estimated and scheduled. We create templates, perform the import of materials, create work items and establish relations between content of documents and implement a full traceability matrix.
Implementation Types
- Train the modeler – Basic setup and training by ION Pharma, you do the rest
- Hybrid – Setup and sharing of implementation workload
- Turnkey – Full implementation by ION Pharma
Chantal van Gorp
Chantal has over 20 years of experience in Quality Assurance in the pharmaceutical (Manufacturing and IT) industry. She has had roles in Production and Quality Assurance.
Modern Requirements4DevOps
Extend Azure DevOps into a Powerful Validation Management System for Life Sciences
We believe the only way in achieving the availability of correct, complete, and compliant information, for the users that need to have it when they need to have it starts with a single unified system at the core of your processes. This isn’t limited to the systems directly handling your Quality and Regulatory data, but also the additional tools used to streamline processes and workflows.
Therefore we see value in the software developed by Modern Requirements that translates that philosophy in a single centralized requirements management tool that is built for every step in the project lifecycle for teams of all sizes working across all methodologies.
Ready to see more?
Get ahead with a Validation Management System (VMS)
Contact Us
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