Case Studies 0 to 13485 in 6 months

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	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
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. Read More
About 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. Read More
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. Read More Log in to view content
Contents

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

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 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.

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.

Impact #1	Karen estimates that core quality management tasks which previously took half a day can now be completed in five minutes.
Impact #2	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.
Impact #3	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.

Impact #1

Karen estimates that core quality management tasks which previously took half a day can now be completed in five minutes.

Impact #2

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.

Impact #3

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.

Benefit #1	97% reduction in quality task completion time.
Benefit #2	ISO 13485 Stage 2 certification unlocked in 6 months.
Benefit #3	3x FTE salaries saved from the bottom line by adopting an eQMS.

Benefit #1

97% reduction in quality task completion time.

Benefit #2

ISO 13485 Stage 2 certification unlocked in 6 months.

Benefit #3

3x FTE salaries saved from the bottom line by adopting an eQMS.

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Overview

0 to 13485 in 6 months

Operational Impact

Quantitative Benefit