Pharma research company accelerates validation processes by 75% with Res_Q

The company's standard software validation process was executed using a hybrid, “paper-paperless” system. Digitally stored computer systems validation (CSV) files were printed, scanned, and signed by team members in disparate physical locations around the country. These files were then manually scanned and uploaded back into digital storage, costing IT & Quality teams unnecessary time and effort. They relied heavily on vendor developers to provide validation packages.

Eventually, the added time, effort, and external dependencies led to a backlog and subsequent validation debt, wherein two major systems were being validated using manual processes. This cost the customer additional time and resources to maintain a state of compliance, forcing personnel to redirect focus away from mission-critical initiatives and towards ongoing validation work.

Solution

To increase efficiency, shorten validation time, and eliminate validation debt, the customer partnered with Sware to implement Res_Q, a modern life sciences SaaS validation platform that automates, unifies, and accelerates validation processes. Today, they use Res_Q to create a fully digital validation ecosystem, automate key workflow elements, maintain superior risk assurance, and drive critical efficiency at all points in the validation lifecycle.

By implementing Res_Q, the customer is now able to:

Build risk management steps directly into the end-to-end workflow

Establish risk criticality and create ranked risk management priorities

Automatically advance validation requirements from stakeholder to stakeholder

Unify 5 industry-supported app validation processes in a single dashboard, including Veeva, Argus, and Optel

Create and finalize signed, audit-ready packages without printers, paper, and ink

Execute proper change management and ensure traceability at all points

As life sciences validation experts, Sware was able to provide the customer with critical strategic planning, challenge anticipation, and solutions mapping. Sware helped meet their current validation needs as well as anticipate future validation requirements, implementing a system capable of scaling to accommodate the customer’s growth trajectory.

Outcomes

Reduced costs, improved efficiency, and easy collaboration across multiple sites

Increased audit-readiness, traceability, and state of compliance at all points

Increased focus for IT and Quality staff on high-value, revenue-generating initiatives

30-40%

reduction in total validation time

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The old way involved more documentation and less critical thinking. The shift from CSV to computer systems assurance (CSA) turned this model on its head. Now, we succeed with less documentation and more critical thinking. With Res_Q, a project requiring 15 validation packages has now been reduced to less than 10.”

VP of QA and Digital Systems
Pharmaceutical Research Company

Outcomes

As a result of the operational changes facilitated by Res_Q, the customer has:

Eliminated its validation debt

Accelerated validation by

75%

Reassigned labor hours equivalent to one full-time employee (FTE)

Ongoing Collaboration

In the future, the customer plans to utilize Res_Q to manage validation for an increasing number of industry apps to support their growing portfolio of drug candidates. Their validation needs are expected to double soon; fortunately, by using Res_Q as its modern validation solution, the customer will be able to accommodate this significant scale-up with minimal disruption and improved overall efficiency.

The Res_Q platform by Sware is helping the customer automate, unify, and accelerate its validation processes. Sware’s mission is to change the way life sciences companies see and eliminate validation debt within their organization, reducing overall CSV costs and ensuring peace of mind in an increasingly complex compliance environment.

The difference pre- and post-Res_Q is simply night and day. What used to take us weeks or months now takes us days or weeks. We’ve essentially eliminated GDP issues by removing the hand-written aspect of document alteration. The system enforces controls, eliminating the long chain of corrections we needed to manage using paper-based processes and communication by scan.”

VP of QA and Digital Systems
Pharmaceutical Research Company