Customer Profile
A growing biotech company on a mission to develop groundbreaking treatments for cancer and infectious disease. Utilizing best-in-class technologies and delivery systems they have developed novel treatments that will revolutionize patient care.
Challenge
- A relatively small team covering multiple site locations lacked a way to centralize and control validation processes
- Validation processes based on “digital paperless” data housing required manual file and resource exchange, draining time and resources
- Outdated workflows require employees to manually review assets and documentation to meet timelines and deliver crucial risk assurance
- A growing volume of required validations contributed to organizational validation debt and placed further pressure on IT and Quality personnel
Res_Q has saved us significant time and resources, allowing us to focus on core business objectives and reducing validation time by 30-40%. I wholeheartedly recommend Res_Q to fellow industry professionals seeking to enhance their validation practices.”
Senior Director, IT Business Partner, GxP Systems
Biotechnology Company
Solution
To address these challenges, the biotech company partnered with Sware to implement Res_Q, a technology platform that automates, unifies, and accelerates life sciences software validation using a single SaaS application. The two companies set several goals to eliminate bottlenecks, drive efficiency, and mitigate risk:
A single, SaaS-based application to bridge validation gaps and offer a single point of control
Workflow automation to expedite and prioritize curation, review, and approval of key documentation
Scale rapidly and flexibly as new requirements emerge, enabling predictable TCOs and further accelerating mandatory activities
Manage all validation processes in one location, increasing visibility, ease of access, and collection of deeper insights about process and quality.
As the solution was implemented, Sware’s functional expertise, proactive planning, and agile methodology helped the biotech company minimize implementation time, answer specific process questions, anticipate challenges, and eliminate the backlog.
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
Outcomes
Reduced costs, improved efficiency, and easy collaboration across multiple sites
reduction in total validation time
Increased audit-readiness, traceability, and state of compliance at all points
Increased focus for IT and Quality staff on high-value, revenue-generating initiatives
Ongoing Collaboration
This biotech company has approached Sware to integrate its bespoke bioinformatic data into the Res_Q workflow. They are collaborating with Sware to ensure a successful implementation, understanding that the Res_Q platform will seamlessly accommodate these complex data streams as it automates, unifies, and accelerates their validation activities.
The Sware team is very knowledgeable regarding validation practices and regulations. They’re always the first to provide insights or point out required plan deviations. Ultimately, they understand that every company is different, and they demonstrate the flexibility needed to provide deliverables that enhance our process.”
Senior Director, IT Business Partner, GxP Systems
Biotechnology Company
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