Case Studies Expert support for a growing company’s first quality steps

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	Expert support for a growing company’s first quality steps

Expert support for a growing company’s first quality steps

Technology Category	Analytics & Modeling - Machine Learning Functional Applications - Enterprise Resource Planning Systems (ERP) Functional Applications - Product Lifecycle Management Systems (PLM)
Applicable Industries	Healthcare & Hospitals Life Sciences
Applicable Functions	Product Research & Development Quality Assurance
Use Cases	Regulatory Compliance Monitoring
Services	System Integration Training
Challenge	The company's continued evolution into the life science sector, and their software's use as a medical device data system (MDDS) for preclinical work, prompted the ViQi team to begin planning a quality and regulatory pathway for the future. Co-founder and CTO Dmitry Fedorov wanted to set a solid, proactive quality baseline for the organization in line with their digital, cloud-based 'mindset'. It was important for the business to embrace modern eQMS technology early, before 'progressively more difficult' regulatory demands started to slow company growth. Critically, the organization had no internal quality expertise. Any quality software vendor they found would need to offer a highly supportive and collaborative relationship. Read More
About Customer	Californian start-up ViQi emerged from UC Santa Barbara and develops cloud-based image analysis software powered by AI and machine learning. Their technology is used by life science organizations to accelerate drug discovery by modeling treatment and cell behavior, and has even been applied by the Bureau of Ocean Energy Management to perform oil spill risk modeling. Read More
Solution	Dmitry and Project Manager Hallie Greene began to search for the perfect eQMS platform and the close QA/ RA support they needed. A call with Sumatha Kondabolu on the Qualio+ team 'sealed the deal’. Going into September 2022, the ViQi team had the ambitious goal of getting the fundamentals of a quality management system in place and getting registered with the FDA by December. They became Qualio customers at the end of the month and let themselves be guided by Qualio's expert onboarding team. Qualio provided both software and support to help ViQi quickly build their quality fundamentals from scratch. The ViQi team received both a brand new, fully digital quality management system and expert quality and regulatory guidance from Sumatha to help them build and populate it, from document and SOP creation to managing workflows and development lifecycles. Sumatha even prepared a special presentation on MDDS regulatory strategy. Her targeted support allowed ViQi to forego an additional $20,000 in planned consultancy spend. Read More Log in to view content
Contents

Technology Category

Analytics & Modeling - Machine Learning

Functional Applications - Enterprise Resource Planning Systems (ERP)

Functional Applications - Product Lifecycle Management Systems (PLM)

Applicable Industries

Healthcare & Hospitals

Life Sciences

Applicable Functions

Product Research & Development

Quality Assurance

Use Cases

Regulatory Compliance Monitoring

Services

System Integration

Training

Challenge

The company's continued evolution into the life science sector, and their software's use as a medical device data system (MDDS) for preclinical work, prompted the ViQi team to begin planning a quality and regulatory pathway for the future. Co-founder and CTO Dmitry Fedorov wanted to set a solid, proactive quality baseline for the organization in line with their digital, cloud-based 'mindset'. It was important for the business to embrace modern eQMS technology early, before 'progressively more difficult' regulatory demands started to slow company growth. Critically, the organization had no internal quality expertise. Any quality software vendor they found would need to offer a highly supportive and collaborative relationship.

About Customer

Californian start-up ViQi emerged from UC Santa Barbara and develops cloud-based image analysis software powered by AI and machine learning. Their technology is used by life science organizations to accelerate drug discovery by modeling treatment and cell behavior, and has even been applied by the Bureau of Ocean Energy Management to perform oil spill risk modeling.

Solution

Dmitry and Project Manager Hallie Greene began to search for the perfect eQMS platform and the close QA/ RA support they needed. A call with Sumatha Kondabolu on the Qualio+ team 'sealed the deal’. Going into September 2022, the ViQi team had the ambitious goal of getting the fundamentals of a quality management system in place and getting registered with the FDA by December. They became Qualio customers at the end of the month and let themselves be guided by Qualio's expert onboarding team. Qualio provided both software and support to help ViQi quickly build their quality fundamentals from scratch. The ViQi team received both a brand new, fully digital quality management system and expert quality and regulatory guidance from Sumatha to help them build and populate it, from document and SOP creation to managing workflows and development lifecycles. Sumatha even prepared a special presentation on MDDS regulatory strategy. Her targeted support allowed ViQi to forego an additional $20,000 in planned consultancy spend.

Impact #1	Qualio provided both software and support to help ViQi quickly build their quality fundamentals from scratch.
Impact #2	The ViQi team received both a brand new, fully digital quality management system and expert quality and regulatory guidance from Sumatha to help them build and populate it, from document and SOP creation to managing workflows and development lifecycles.
Impact #3	Sumatha even prepared a special presentation on MDDS regulatory strategy. Her targeted support allowed ViQi to forego an additional $20,000 in planned consultancy spend.

Impact #1

Qualio provided both software and support to help ViQi quickly build their quality fundamentals from scratch.

Impact #2

The ViQi team received both a brand new, fully digital quality management system and expert quality and regulatory guidance from Sumatha to help them build and populate it, from document and SOP creation to managing workflows and development lifecycles.

Impact #3

Sumatha even prepared a special presentation on MDDS regulatory strategy. Her targeted support allowed ViQi to forego an additional $20,000 in planned consultancy spend.

Benefit #1	$20,000 of consultancy spend mitigated
Benefit #2	12 weeks to construct an eQMS from scratch
Benefit #3	35 key quality documents built with Qualio+ support

Benefit #1

$20,000 of consultancy spend mitigated

Benefit #2

12 weeks to construct an eQMS from scratch

Benefit #3

35 key quality documents built with Qualio+ support

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Overview

Expert support for a growing company’s first quality steps

Operational Impact

Quantitative Benefit