Case Studies IRISYS Uses Qualio to Help Biotech and Pharmaceutical Firms Secure FDA Approval

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	IRISYS Uses Qualio to Help Biotech and Pharmaceutical Firms Secure FDA Approval

IRISYS Uses Qualio to Help Biotech and Pharmaceutical Firms Secure FDA Approval

Technology Category	Application Infrastructure & Middleware - Data Exchange & Integration Application Infrastructure & Middleware - Data Visualization Functional Applications - Enterprise Resource Planning Systems (ERP)
Applicable Industries	Life Sciences Pharmaceuticals
Applicable Functions	Business Operation Quality Assurance
Use Cases	Regulatory Compliance Monitoring Remote Collaboration
Services	Software Design & Engineering Services System Integration Training
Challenge	As a smaller operation, IRISYS relied on a paper-based system where everything—including all SOPs—were printed out and signed by hand. Eventually, these documents would be scanned and put on a shared network drive. But it was still a manual process that took a lot of time. While this system worked well enough for a company with a handful of staffers, IRISYS started to scale rapidly. Between 2014 and 2017, the company expanded from 10 to around 50 full-time employees. With this growth came a lot more research and a lot more documentation. Read More
About Customer	IRISYS is a contract development and manufacturing organization (CDMO) headquartered in San Diego that helps biotech and pharmaceutical firms manufacture clinical drugs, drug delivery technologies, and formulations for rare diseases and orphan drugs, and get them approved by the FDA. When IRISYS contracts with partner firms, they assist with R&D, manufacturing, and regulatory processes. In addition to this, the company also has a small product portfolio of its own that includes the SCOT-TUSSIN family of sugar-free and alcohol-free cough medicines. Read More
Solution	IRISYS quickly realized they needed a better solution for quality management that would enable them to move faster. To find a solution, Ramirez and his team conducted Google and LinkedIn searches to see what other folks in the industry were using for quality management. Eventually, Ramirez ended up with a list of 30 or so eQMS systems and began investigating them further. Right off the bat, IRISYS realized that while platforms like MasterControl and Veeva offered a lot of features, the smaller CDMO didn’t need all those bells and whistles. After testing a different solution in sandbox mode and finding it was full of bugs, Ramirez decided to test Qualio next. Liking what they saw, the IRISYS team ultimately decided to invest in Qualio as their eQMS solution. Read More Log in to view content
Contents

Technology Category

Application Infrastructure & Middleware - Data Exchange & Integration

Application Infrastructure & Middleware - Data Visualization

Functional Applications - Enterprise Resource Planning Systems (ERP)

Applicable Industries

Life Sciences

Pharmaceuticals

Applicable Functions

Business Operation

Quality Assurance

Use Cases

Regulatory Compliance Monitoring

Remote Collaboration

Services

Software Design & Engineering Services

System Integration

Training

Challenge

As a smaller operation, IRISYS relied on a paper-based system where everything—including all SOPs—were printed out and signed by hand. Eventually, these documents would be scanned and put on a shared network drive. But it was still a manual process that took a lot of time. While this system worked well enough for a company with a handful of staffers, IRISYS started to scale rapidly. Between 2014 and 2017, the company expanded from 10 to around 50 full-time employees. With this growth came a lot more research and a lot more documentation.

About Customer

IRISYS is a contract development and manufacturing organization (CDMO) headquartered in San Diego that helps biotech and pharmaceutical firms manufacture clinical drugs, drug delivery technologies, and formulations for rare diseases and orphan drugs, and get them approved by the FDA. When IRISYS contracts with partner firms, they assist with R&D, manufacturing, and regulatory processes. In addition to this, the company also has a small product portfolio of its own that includes the SCOT-TUSSIN family of sugar-free and alcohol-free cough medicines.

Solution

IRISYS quickly realized they needed a better solution for quality management that would enable them to move faster. To find a solution, Ramirez and his team conducted Google and LinkedIn searches to see what other folks in the industry were using for quality management. Eventually, Ramirez ended up with a list of 30 or so eQMS systems and began investigating them further. Right off the bat, IRISYS realized that while platforms like MasterControl and Veeva offered a lot of features, the smaller CDMO didn’t need all those bells and whistles. After testing a different solution in sandbox mode and finding it was full of bugs, Ramirez decided to test Qualio next. Liking what they saw, the IRISYS team ultimately decided to invest in Qualio as their eQMS solution.

Impact #1	Increased productivity: Qualio has enabled the QA team at IRISYS to keep up with their increased workload. The system allows for faster document management and collaboration, even when working remotely due to COVID-19.
Impact #2	Standardization: Moving from a paper-based system to an eQMS has made it much easier to standardize all SOPs, with standardization built into Qualio.
Impact #3	Increased compliance: Since moving to Qualio, IRISYS has had no problems passing audits from the FDA, FDB, and DEA. The changelog feature in Qualio has been particularly helpful for compliance.

Impact #1

Increased productivity: Qualio has enabled the QA team at IRISYS to keep up with their increased workload. The system allows for faster document management and collaboration, even when working remotely due to COVID-19.

Impact #2

Standardization: Moving from a paper-based system to an eQMS has made it much easier to standardize all SOPs, with standardization built into Qualio.

Impact #3

Increased compliance: Since moving to Qualio, IRISYS has had no problems passing audits from the FDA, FDB, and DEA. The changelog feature in Qualio has been particularly helpful for compliance.

Benefit #1	IRISYS expanded from 10 to around 50 full-time employees between 2014 and 2017.
Benefit #2	IRISYS has been able to manage an increased workload without needing to grow the QA team proportionally, allowing for more resources to be allocated to revenue-generating roles.

Benefit #1

IRISYS expanded from 10 to around 50 full-time employees between 2014 and 2017.

Benefit #2

IRISYS has been able to manage an increased workload without needing to grow the QA team proportionally, allowing for more resources to be allocated to revenue-generating roles.

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Overview

IRISYS Uses Qualio to Help Biotech and Pharmaceutical Firms Secure FDA Approval

Operational Impact

Quantitative Benefit