A leading pharmaceutical client, using Kneat since 2019, partnered with No deviation for a critical upgrade from version 8.8 to 9.3. Their goal: improve system performance, usability, and compliance. The result: a smooth and compliant transition.
What We Delivered
- User Requirement Specification (URS): Defining expectations and user needs.
- Functional Risk Assessment (FRA): Identifying key risks and mapping them to controls.
- Requirement Traceability Matrix (RTM): Ensuring all requirements were covered and verified.
- User Acceptance Testing (UAT): Validating the final solution from an end-user perspective.
We followed a risk-based approach and worked closely with Kneat’s documentation to ensure correct configuration.
Challenges We Overcame
- Heavy Documentation Requirements:
Our experienced team ensured efficient preparation, review, and delivery of validation documentation. - Tight Timelines:
We implemented rolling interviews and parallel review processes to accelerate progress. - Time Zone Differences:
With international teams, we maintained clear communication protocols and leveraged shared tools like Teams and SharePoint.
The Outcome
A seamless upgrade delivered on time, meeting all compliance standards and enhancing system performance. Our collaborative approach reinforced user confidence and regulatory alignment.
Key Takeaways
- Start with Strong Planning: Define deliverables, risks, and resources early.
- Use Vendor Documentation Smartly: Kneat’s packages are a time-saver — use them as a backbone.
- Communicate Relentlessly: Keep channels open and teams aligned across regions.
Thinking about upgrading your Kneat system or deploying it in your organization? Contact us at hello@nodeviation.com — we’d be happy to help!
Why has digital validation become the standard in pharma?
The pharmaceutical industry is under constant pressure to deliver safe, compliant products while accelerating time-to-market. Traditional paper-based validation processes are time-consuming, error-prone, and difficult to scale.
Digital validation platforms like Kneat:
- Reduce manual errors and improve data integrity.
- Enable faster turnaround and streamlined documentation.
- Offer real-time visibility, traceability, and audit-readiness.
- Support global teams in collaborating efficiently.
- Help companies stay aligned with increasingly complex regulatory requirements. In short, digital validation has become the standard because it combines efficiency, reliability, and regulatory robustness — all critical in today’s pharma landscape.
Interested in a smooth Kneat Upgrade?
Would you like to upgrade your Kneat platform? Get in touch with us at hello@nodeviation.com — we’d love to help make it smooth and efficient.
