Case Studies VitaCyte uses Qualio to manufacture highly purified cell recovery reagents

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	VitaCyte uses Qualio to manufacture highly purified cell recovery reagents

VitaCyte uses Qualio to manufacture highly purified cell recovery reagents

Technology Category	Application Infrastructure & Middleware - Data Exchange & Integration Cybersecurity & Privacy - Security Compliance Functional Applications - Enterprise Resource Planning Systems (ERP)
Applicable Functions	Business Operation Quality Assurance
Use Cases	Regulatory Compliance Monitoring
Services	System Integration Training
Challenge	VitaCyte began as an early-stage startup funded by an NIH grant as it pursued a commercialization path for reagents used for the recovery of cells used in human transplant therapies. From the outset, the VitaCyte team knew they would need a robust quality management system to achieve their goals. But with limited resources, that wasn’t really practical. So they built a paper-based system from the ground up knowing that they’d have to eventually migrate to something more sophisticated. VitaCyte manufactures ancillary reagents that are used in the preparation of cells, operating in an evolving, yet-to-be-fully defined regulatory space. Recently, the company was audited by a customer’s quality team, and the experience led VitaCyte to begin the process of searching for a new quality management system. Read More
About Customer	VitaCyte is a biotechnology company that manufactures high-purity tissue dissociation enzymes and cell recovery reagents, including collagenase. The company’s product portfolio is designed to correlate optimal enzyme activity with specific cell and tissue types to maximize viable cell yields. VitaCyte, which was founded in 2004 and is headquartered in Indianapolis, has 11 employees. The company operates in the niche regenerative medicine and cell therapy space, focusing on the preparation of cells for human transplant therapies. VitaCyte's products are used in an evolving regulatory environment, necessitating a robust quality management system to ensure compliance and operational efficiency. Read More
Solution	As VitaCyte began looking for a new solution, they examined a few eDoc platforms and found that most of them were feature-heavy and rigid, catering to established pharmaceutical businesses and manufacturers of already-certified materials. After exploring their options, VitaCyte ultimately decided that Qualio, the electronic quality management system (eQMS) built for medical device, biotech, and pharma companies, was best-suited for their needs. Qualio provided a powerful and adaptable quality management system that met VitaCyte's specific requirements. The platform offered seamless onboarding, with high-touch support from the Qualio team, enabling VitaCyte to migrate all their existing documents quickly. Qualio's system adopted VitaCyte's existing numbering and organization conventions, ensuring a smooth transition. Additionally, Qualio's secure and reliable architecture, with data encryption in transit and at rest, provided VitaCyte with the necessary security for their trade secrets. Read More Log in to view content
Contents

Technology Category

Application Infrastructure & Middleware - Data Exchange & Integration

Cybersecurity & Privacy - Security Compliance

Functional Applications - Enterprise Resource Planning Systems (ERP)

Applicable Functions

Business Operation

Quality Assurance

Use Cases

Regulatory Compliance Monitoring

Services

System Integration

Training

Challenge

VitaCyte began as an early-stage startup funded by an NIH grant as it pursued a commercialization path for reagents used for the recovery of cells used in human transplant therapies. From the outset, the VitaCyte team knew they would need a robust quality management system to achieve their goals. But with limited resources, that wasn’t really practical. So they built a paper-based system from the ground up knowing that they’d have to eventually migrate to something more sophisticated. VitaCyte manufactures ancillary reagents that are used in the preparation of cells, operating in an evolving, yet-to-be-fully defined regulatory space. Recently, the company was audited by a customer’s quality team, and the experience led VitaCyte to begin the process of searching for a new quality management system.

About Customer

VitaCyte is a biotechnology company that manufactures high-purity tissue dissociation enzymes and cell recovery reagents, including collagenase. The company’s product portfolio is designed to correlate optimal enzyme activity with specific cell and tissue types to maximize viable cell yields. VitaCyte, which was founded in 2004 and is headquartered in Indianapolis, has 11 employees. The company operates in the niche regenerative medicine and cell therapy space, focusing on the preparation of cells for human transplant therapies. VitaCyte's products are used in an evolving regulatory environment, necessitating a robust quality management system to ensure compliance and operational efficiency.

Solution

As VitaCyte began looking for a new solution, they examined a few eDoc platforms and found that most of them were feature-heavy and rigid, catering to established pharmaceutical businesses and manufacturers of already-certified materials. After exploring their options, VitaCyte ultimately decided that Qualio, the electronic quality management system (eQMS) built for medical device, biotech, and pharma companies, was best-suited for their needs. Qualio provided a powerful and adaptable quality management system that met VitaCyte's specific requirements. The platform offered seamless onboarding, with high-touch support from the Qualio team, enabling VitaCyte to migrate all their existing documents quickly. Qualio's system adopted VitaCyte's existing numbering and organization conventions, ensuring a smooth transition. Additionally, Qualio's secure and reliable architecture, with data encryption in transit and at rest, provided VitaCyte with the necessary security for their trade secrets.

Impact #1	Seamless Onboarding: Thanks to high-touch support from the Qualio team, VitaCyte was able to get up and running on the platform quickly. Qualio offered to migrate all existing documents, addressing concerns about numbering conventions and ensuring a smooth transition.
Impact #2	Immediate Impact: VitaCyte started using Qualio concurrently with the migration, and the ROI was immediate. The company now manages policies, SOPs, test procedures, and master batch records through the eQMS.
Impact #3	Streamlined Training: Qualio has helped VitaCyte ensure employees are up to speed with the newest policies, procedures, and objectives, enhancing overall operational efficiency.

Impact #1

Seamless Onboarding: Thanks to high-touch support from the Qualio team, VitaCyte was able to get up and running on the platform quickly. Qualio offered to migrate all existing documents, addressing concerns about numbering conventions and ensuring a smooth transition.

Impact #2

Immediate Impact: VitaCyte started using Qualio concurrently with the migration, and the ROI was immediate. The company now manages policies, SOPs, test procedures, and master batch records through the eQMS.

Impact #3

Streamlined Training: Qualio has helped VitaCyte ensure employees are up to speed with the newest policies, procedures, and objectives, enhancing overall operational efficiency.

Benefit #1	Within three months, VitaCyte integrated 200 effective documents into Qualio.
Benefit #2	They have since added 100 additional documents.

Benefit #1

Within three months, VitaCyte integrated 200 effective documents into Qualio.

Benefit #2

They have since added 100 additional documents.

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Overview

VitaCyte uses Qualio to manufacture highly purified cell recovery reagents

Operational Impact

Quantitative Benefit