Case Studies Restech's Transition to Qualio's eQMS for Enhanced Quality Management

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	Restech's Transition to Qualio's eQMS for Enhanced Quality Management

Restech's Transition to Qualio's eQMS for Enhanced Quality Management

Technology Category	Functional Applications - Computerized Maintenance Management Systems (CMMS) Functional Applications - Enterprise Resource Planning Systems (ERP)
Applicable Industries	Healthcare & Hospitals
Applicable Functions	Business Operation Quality Assurance
Services	System Integration Training
Challenge	Restech and its Director of Quality Assurance, Lowell Hoffman, faced significant challenges with their manual, paper-based quality management system (QMS). The old system was labor-intensive, time-consuming, and prone to human errors. Document control was particularly problematic, with local saving of document copies preventing access to centralized, up-to-date information. The process of creating paper folders and collecting wet signatures was also time-demanding. These inefficiencies hindered Restech's ability to maintain strong document control, which is crucial for a robust QMS, especially in the medical device industry where regulatory compliance is stringent. Read More
About Customer	Restech is a medical device company specializing in the production of devices for minimally invasive diagnosis and treatment of reflux disorders. The company has experienced impressive growth and operates in multiple international territories. To support its operations and ensure compliance with various regulations such as FDA 21 CFR 820, ISO 13485, CGMP, EU MDR, and UK Medical Device Regulations, Restech required a carefully constructed Quality Management System (QMS). The company's commitment to quality and regulatory compliance is evident in its adoption of advanced quality management solutions. Read More
Solution	To address these challenges, Restech decided to adopt an electronic quality management system (eQMS). After evaluating various options, Lowell Hoffman and the senior management team chose Qualio as the optimal platform. The decision was based on several criteria, including cost, ease of use, look and feel, ease of setup and transfer from the old QMS, and long-term customer support. Qualio's eQMS provided a comprehensive solution that eliminated the administrative burden of the paper-based system. It streamlined document control processes, reduced the time required for document updates, and minimized human errors. Additionally, Qualio's digital workflows for managing quality events like CAPAs and deviations significantly improved efficiency. Read More Log in to view content
Contents

Technology Category

Functional Applications - Computerized Maintenance Management Systems (CMMS)

Functional Applications - Enterprise Resource Planning Systems (ERP)

Applicable Industries

Healthcare & Hospitals

Applicable Functions

Business Operation

Quality Assurance

Services

System Integration

Training

Challenge

Restech and its Director of Quality Assurance, Lowell Hoffman, faced significant challenges with their manual, paper-based quality management system (QMS). The old system was labor-intensive, time-consuming, and prone to human errors. Document control was particularly problematic, with local saving of document copies preventing access to centralized, up-to-date information. The process of creating paper folders and collecting wet signatures was also time-demanding. These inefficiencies hindered Restech's ability to maintain strong document control, which is crucial for a robust QMS, especially in the medical device industry where regulatory compliance is stringent.

About Customer

Restech is a medical device company specializing in the production of devices for minimally invasive diagnosis and treatment of reflux disorders. The company has experienced impressive growth and operates in multiple international territories. To support its operations and ensure compliance with various regulations such as FDA 21 CFR 820, ISO 13485, CGMP, EU MDR, and UK Medical Device Regulations, Restech required a carefully constructed Quality Management System (QMS). The company's commitment to quality and regulatory compliance is evident in its adoption of advanced quality management solutions.

Solution

To address these challenges, Restech decided to adopt an electronic quality management system (eQMS). After evaluating various options, Lowell Hoffman and the senior management team chose Qualio as the optimal platform. The decision was based on several criteria, including cost, ease of use, look and feel, ease of setup and transfer from the old QMS, and long-term customer support. Qualio's eQMS provided a comprehensive solution that eliminated the administrative burden of the paper-based system. It streamlined document control processes, reduced the time required for document updates, and minimized human errors. Additionally, Qualio's digital workflows for managing quality events like CAPAs and deviations significantly improved efficiency.

Impact #1	Qualio transformed Restech's quality management from a manual, administrative exercise to a continuous improvement tool. The transition to a paperless system allowed a single Qualio administrator to manage the company's information with ease, freeing up multiple hours each week for other department leads.
Impact #2	Document update processes that previously took two weeks were reduced to just four hours. The digital workflows for quality events cut ten days from each event close-out, enhancing overall efficiency.
Impact #3	Restech achieved 100% on-time completion of quality training for its team, positioning the company effectively for regulatory scrutiny. In a recent ISO 13485 audit, Restech received zero non-conformances, highlighting the effectiveness of the new eQMS.

Impact #1

Qualio transformed Restech's quality management from a manual, administrative exercise to a continuous improvement tool. The transition to a paperless system allowed a single Qualio administrator to manage the company's information with ease, freeing up multiple hours each week for other department leads.

Impact #2

Document update processes that previously took two weeks were reduced to just four hours. The digital workflows for quality events cut ten days from each event close-out, enhancing overall efficiency.

Impact #3

Restech achieved 100% on-time completion of quality training for its team, positioning the company effectively for regulatory scrutiny. In a recent ISO 13485 audit, Restech received zero non-conformances, highlighting the effectiveness of the new eQMS.

Benefit #1	95% reduction in document control process time.
Benefit #2	Two weeks saved in resolving each quality event.
Benefit #3	Zero non-conformances in ISO 13485 audits.

Benefit #1

95% reduction in document control process time.

Benefit #2

Two weeks saved in resolving each quality event.

Benefit #3

Zero non-conformances in ISO 13485 audits.

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Overview

Restech's Transition to Qualio's eQMS for Enhanced Quality Management

Operational Impact

Quantitative Benefit