Case Studies How Solius Replaced Paper with Eqms to Gain ISO 13485:2016 Certification in Weeks

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	How Solius Replaced Paper with Eqms to Gain ISO 13485:2016 Certification in Weeks

How Solius Replaced Paper with Eqms to Gain ISO 13485:2016 Certification in Weeks

Technology Category	Functional Applications - Computerized Maintenance Management Systems (CMMS) Functional Applications - Enterprise Resource Planning Systems (ERP)
Applicable Industries	Healthcare & Hospitals Life Sciences
Applicable Functions	Quality Assurance Business Operation
Use Cases	Regulatory Compliance Monitoring
Services	System Integration Training
Challenge	The vision at SOLIUS was to bring the product to market as a medical device, meaning that their team was aware of the quality management regulations they would have to comply with. With four team members at the time, managing compliance and a QMS was an immediate hurdle they needed to overcome. They began to vet solutions that would help them manage the regulatory and quality requirements of their target markets, without them becoming overwhelmed with compliance efforts. They began searching for a solution that was cloud-based, secure, affordable, scalable, and came with advice from industry experts that could guide them along the way. Read More
About Customer	SOLIUS was founded by a duo seven years ago, but their product development efforts have ramped up in the past several years. Their device is a Class II phototherapy device that bridges a medical device and a wellness device that stimulates the body to produce Vitamin D–something the body is already meant to do. SOLIUS’ device is the first of its kind in terms of its labeling and conditions for use. This makes their pathway to market a bit more unique and may present some challenges. Their goal is to successfully bring their device to market with its current labeling with Health Canada, then meet with the FDA to assess how the device will be received. Read More
Solution	No one on the SOLIUS team had any expertise in medical device quality management at the time, leaving them thoroughly impressed by the talent and experience onboard at Greenlight Guru. These industry experts gave the team at SOLIUS the confidence in what they were doing with the software and industry knowledge. When it came down to making a decision, SOLIUS went with Greenlight Guru due to the stability of the company, impressive talent industry gurus onboard, and the stability of Greenlight Guru as a company. Linda Cox, Senior VP, QA/RA/Clinical Initiative at SOLIUS, assessed the cost of Greenlight Guru and decided that it was well worth it. Along with the software, they found immense value in the on-boarding process, knowledge base, and QMS templates. It was Greenlight Guru’s Customer Success Team that played a paramount role, providing guidance and mentorship during their earlier days. SOLIUS’ CTO worked with Greenlight Guru to get the software up and running, and found that the team was excellent in helping them get the system in place. It took them a few months to transfer all of their data into the system, due to initial hesitancy that they would make mistakes. Once they transferred over their data, they realized that there was really no way for them to mess it up. The team at SOLIUS worked with Greenlight Guru’s Customer Success Team on adopting the product and ensuring that their processes were sound. The guidance provided by Greenlight Guru reassured SOLIUS that they had made the right decision. 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

Life Sciences

Applicable Functions

Quality Assurance

Business Operation

Use Cases

Regulatory Compliance Monitoring

Services

System Integration

Training

Challenge

The vision at SOLIUS was to bring the product to market as a medical device, meaning that their team was aware of the quality management regulations they would have to comply with. With four team members at the time, managing compliance and a QMS was an immediate hurdle they needed to overcome. They began to vet solutions that would help them manage the regulatory and quality requirements of their target markets, without them becoming overwhelmed with compliance efforts. They began searching for a solution that was cloud-based, secure, affordable, scalable, and came with advice from industry experts that could guide them along the way.

About Customer

SOLIUS was founded by a duo seven years ago, but their product development efforts have ramped up in the past several years. Their device is a Class II phototherapy device that bridges a medical device and a wellness device that stimulates the body to produce Vitamin D–something the body is already meant to do. SOLIUS’ device is the first of its kind in terms of its labeling and conditions for use. This makes their pathway to market a bit more unique and may present some challenges. Their goal is to successfully bring their device to market with its current labeling with Health Canada, then meet with the FDA to assess how the device will be received.

Solution

No one on the SOLIUS team had any expertise in medical device quality management at the time, leaving them thoroughly impressed by the talent and experience onboard at Greenlight Guru. These industry experts gave the team at SOLIUS the confidence in what they were doing with the software and industry knowledge. When it came down to making a decision, SOLIUS went with Greenlight Guru due to the stability of the company, impressive talent industry gurus onboard, and the stability of Greenlight Guru as a company. Linda Cox, Senior VP, QA/RA/Clinical Initiative at SOLIUS, assessed the cost of Greenlight Guru and decided that it was well worth it. Along with the software, they found immense value in the on-boarding process, knowledge base, and QMS templates. It was Greenlight Guru’s Customer Success Team that played a paramount role, providing guidance and mentorship during their earlier days. SOLIUS’ CTO worked with Greenlight Guru to get the software up and running, and found that the team was excellent in helping them get the system in place. It took them a few months to transfer all of their data into the system, due to initial hesitancy that they would make mistakes. Once they transferred over their data, they realized that there was really no way for them to mess it up. The team at SOLIUS worked with Greenlight Guru’s Customer Success Team on adopting the product and ensuring that their processes were sound. The guidance provided by Greenlight Guru reassured SOLIUS that they had made the right decision.

Impact #1	SOLIUS achieved their ISO 13485:2016 certification with just two dedicated employees–James and Linda (as a half-time employee as her other focus is on clinical efforts). Having previously worked with a paper-based system and other ad-hoc systems before, Linda says that gaining certification with any other approach would be next to impossible with the only two resources. They usually require a number of people to get everything together, with a process already in place.
Impact #2	Their other achievements leading to their ISO 13485:2016 certification include making it through their audit in 3 days rather than 3.5, cutting down the time required to prepare for an audit by at least a week, and taking only a matter of days to review their design matrix and check for supporting documents.
Impact #3	In James’ previous experience, there have been paper-based design history files and risk management files, along with matrices in Excel which quickly become a nightmare to manage. Greenlight Guru made it very simple to easily find and link these complex matrices. If something was referenced, then it could be found.

Impact #1

SOLIUS achieved their ISO 13485:2016 certification with just two dedicated employees–James and Linda (as a half-time employee as her other focus is on clinical efforts). Having previously worked with a paper-based system and other ad-hoc systems before, Linda says that gaining certification with any other approach would be next to impossible with the only two resources. They usually require a number of people to get everything together, with a process already in place.

Impact #2

Their other achievements leading to their ISO 13485:2016 certification include making it through their audit in 3 days rather than 3.5, cutting down the time required to prepare for an audit by at least a week, and taking only a matter of days to review their design matrix and check for supporting documents.

Impact #3

In James’ previous experience, there have been paper-based design history files and risk management files, along with matrices in Excel which quickly become a nightmare to manage. Greenlight Guru made it very simple to easily find and link these complex matrices. If something was referenced, then it could be found.

Benefit #1	Achieved ISO 13485:2016 certification in weeks.
Benefit #2	Audit duration reduced from 3.5 days to 3 days.
Benefit #3	Time to prepare for an audit reduced by at least a week.

Benefit #1

Achieved ISO 13485:2016 certification in weeks.

Benefit #2

Audit duration reduced from 3.5 days to 3 days.

Benefit #3

Time to prepare for an audit reduced by at least a week.

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Overview

How Solius Replaced Paper with Eqms to Gain ISO 13485:2016 Certification in Weeks

Operational Impact

Quantitative Benefit