Case Studies > From ‘pain’ to ‘fun’

From ‘pain’ to ‘fun’

Company Size
11-200
Region
  • America
Country
  • United States
Product
  • Qualio
  • Qualio+
  • MasterControl
  • Greenlight Guru
  • TrackWise
Tech Stack
  • eQMS
  • Document Management
  • Training Management
  • Quality Event Management
Implementation Scale
  • Enterprise-wide Deployment
Impact Metrics
  • Customer Satisfaction
  • Digital Expertise
  • Productivity Improvements
Technology Category
  • Functional Applications - Computerized Maintenance Management Systems (CMMS)
  • Functional Applications - Enterprise Resource Planning Systems (ERP)
  • Functional Applications - Product Lifecycle Management Systems (PLM)
Applicable Industries
  • Healthcare & Hospitals
  • Pharmaceuticals
Applicable Functions
  • Business Operation
  • Quality Assurance
Use Cases
  • Regulatory Compliance Monitoring
Services
  • System Integration
  • Training
About The Customer
Tennessee-based Helix Biotech, founded in May 2022, develops and manufactures lipid nanoparticles, liposomes, and hybrid nanoparticles for customers, as well as producing manufacturing tools like extrusion and injection systems. Robust quality and GMP processes are vital to support the company's work from R&D to manufacturing.
The Challenge
Founder and President Graham Taylor began his career in quality as an associate quality engineer in 2007. Having spent over 15 years in the medical device and pharmaceutical worlds, he recognized the importance of an optimized QMS as he set up Helix. At a previous role, Graham battled the time and effort demands of a paper-based quality system, which included constant circulation, completion, and filing of paper documents. A single FTE, a full 10% of labor costs, was swallowed up by quality admin demands. With Helix as a blank slate, Graham wanted to sidestep the effort of paper and build an efficient, easy-to-run quality system from the company's first days.
The Solution
Graham compared multiple eQMS vendors like MasterControl and Greenlight Guru, and found it 'easy' to home in on Qualio as the most valuable and sensibly priced option on the market. Graham was also swayed by Qualio's 'straightforward’, ‘refreshing’ and 'easy-to-use' interface, particularly in relation to other, less intuitive systems he'd used in the past like TrackWise. Graham trusted Qualio with the future of his infant company’s quality system and went live with the software in October 2022.
Operational Impact
  • Qualio empowered Helix Biotech with a quality cornerstone to begin their journey. Rapid set-up of a quality foundation. The infancy of Helix Biotech meant Graham faced a double task of scaling the company and building a quality management system from scratch. Starting with Qualio, and leveraging extra guidance and support from the Qualio+ team, made that task rapid and simple.
  • Helix’s shiny new eQMS was populated with industry-ready document templates and augmented by expert Qualio+ QA/RA guidance. Helix established the structure of their biotech quality management system within a matter of weeks of becoming Qualio customers.
  • An eQMS to connect the business from day 1. Graham wanted an easy-to-use, collaborative eQMS to build his company around. All Helix employees now use Qualio day-to-day, accessing a continuously expanding single source of truth quality, manufacturing and more. And as new employees are onboarded, they can be integrated into Helix’s quality approach quickly and easily. 90% of company activity is already housed in Qualio.
  • Setting a lean and agile quality precedent. By maximizing speed and minimizing clutter with a fully digital eQMS, Graham and the Helix team have set a high-quality precedent to carry forward. Quality events, such as deviations, can already be closed out a full 3 days quicker than in Graham's previous organization. 95% of scheduled training is completed on time, with an average of 2 days' completion time - a significant boost from what Graham experienced in other roles.
  • The dreaded 'document dance' of manual paper-shuffling has been completely demolished, freeing up Helix staff to evolve the company without time-sapping admin.
Quantitative Benefit
  • 1x FTE of quality admin mitigated.
  • 3 days sliced from each quality event close-out time.
  • 95% of scheduled training is completed on time, with an average of 2 days' completion time.
  • 90% of company activity is already housed in Qualio.

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