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Case Studies > 0 to 13485 in 6 months

0 to 13485 in 6 months

Technology Category
  • Functional Applications - Enterprise Resource Planning Systems (ERP)
Applicable Industries
  • Pharmaceuticals
Applicable Functions
  • Business Operation
  • Quality Assurance
Services
  • Software Design & Engineering Services
  • System Integration
  • Training
The Challenge
30 Technology has two products in development for the market. A quality culture of continuous improvement means the business is constantly looking to challenge existing processes, embed a right-first-time go-to-market approach, and unlock faster, smarter ways of doing things. Above all, a largely remote team required digital access to, and training on, the latest and greatest operating procedures with strict version control. However, a heavily paper-based QMS meant a slew of time-heavy manual processes which cluttered and complicated compliance, as Head of Quality & GxP Compliance Karen Hue discovered when she joined the business. Karen wanted to implement a simpler electronic way of managing the 30 Technology QMS, that matched the company's size. Speed, agility, cost-effectiveness, and ease of use were the primary requirements.
About The Customer
30 Technology is a UK-based developer of therapeutic nitric oxide products. With a medical device in development and laboratory-driven pharmaceutical products as well, 30 Technology has a complex double regulatory landscape to navigate. The company is committed to a quality culture of continuous improvement and is constantly looking to challenge existing processes, embed a right-first-time go-to-market approach, and unlock faster, smarter ways of doing things. The team is largely remote, requiring digital access to the latest operating procedures with strict version control.
The Solution
Two weeks after joining 30 Technology in November 2020, Karen led the search for an electronic quality management system (eQMS) and approached three vendors after a Google search. Karen was impressed by Qualio and had a detailed discussion about how Qualio's software would fit into 30 Technology's operation, including cost, users, and scalability potential. After a rapid implementation and validation process, Karen and 30 Technology's Qualio system went live in mid-December and was christened Fort NOx: a nod to Qualio's security credentials and 30 Technology's nitrous oxide product base. By January, all users were fully trained and accessing Qualio on a daily basis – less than two months after Karen's search began.
Operational Impact
  • Karen estimates that core quality management tasks which previously took half a day can now be completed in five minutes.
  • Karen quantified the ROI of her Qualio system by comparing its cost with the manual personnel work that would have been required without it, and estimates a saving of at least three FTE salaries from the company's bottom line.
  • Karen now enjoys complete control and oversight of her QMS, while her colleagues access a single source of truth for documents, training records, and more.
Quantitative Benefit
  • 97% reduction in quality task completion time.
  • ISO 13485 Stage 2 certification unlocked in 6 months.
  • 3x FTE salaries saved from the bottom line by adopting an eQMS.

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