Case Studies Medicines360 Takes Control of Regulated Content with Vault QualityDocs

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	Medicines360 Takes Control of Regulated Content with Vault QualityDocs

Medicines360 Takes Control of Regulated Content with Vault QualityDocs

Technology Category	Platform as a Service (PaaS) - Connectivity Platforms
Applicable Industries	Healthcare & Hospitals Pharmaceuticals
Applicable Functions	Quality Assurance Product Research & Development
Use Cases	Regulatory Compliance Monitoring Remote Collaboration
Services	Cloud Planning, Design & Implementation Services System Integration
Challenge	Medicines360, a nonprofit pharmaceutical company, was facing challenges in controlling and securely sharing regulated content among its geographically dispersed teams and partners. The company was heavily reliant on email, file share, and a paper-based system, which made it difficult for remote employees or contractors to access standard operating procedures (SOPs) or other regulated documents. As the company was transitioning from research and development to launching and commercializing its first product, it was struggling with complex and inefficient processes for developing, reviewing, approving, and tracking training of controlled documents. Without a single document management system that was easily accessible from anywhere, the company lacked a consistent and efficient way to distribute controlled content and track SOP training to ensure compliance. Read More
About Customer	Medicines360 is an innovative, global nonprofit, women’s health pharmaceutical company with a mission of expanding access to quality medicines, regardless of socioeconomics, insurance coverage, or geographic location. The U.S. Food and Drug Administration (FDA) recently approved Medicines360’s Liletta™ (levonorgestrel), a hormonal intrauterine device (IUD). The company is now ramping up commercialization of its new product. Medicines360 relies heavily on geographically dispersed teams and partners. With only email, file share, and a paper-based system, it was challenging to control and securely share regulated content. It was also not feasible for remote employees or contractors to come into the office when they needed to refer to a standard operating procedure (SOP) or other regulated document. Read More
Solution	Medicines360 implemented Veeva Vault QualityDocs, a cloud-based, advanced content management technology. The solution met all the company's requirements, including an intuitive user interface, robust audit trail, compliant electronic signatures, and validation support. Vault QualityDocs is accessible from any major web browser, allowing users to easily learn and access the application from anywhere. The solution also provides true multitenant cloud and validation-ready software updates, ensuring that Medicines360 is always on the latest release. The ability to seamlessly view PDF documents removed the infrastructure complexity and connection challenges experienced with other applications. The implementation of Vault QualityDocs was completed faster than expected due to its native life sciences-specific functionality, including preconfigured quality workflows and document taxonomy. The solution's cross-browser, cross-platform functionality allows Medicines360 to easily collaborate with different functional areas and share best practices in real time. Read More Log in to view content
Contents

Technology Category

Platform as a Service (PaaS) - Connectivity Platforms

Applicable Industries

Healthcare & Hospitals

Pharmaceuticals

Applicable Functions

Quality Assurance

Product Research & Development

Use Cases

Regulatory Compliance Monitoring

Remote Collaboration

Services

Cloud Planning, Design & Implementation Services

System Integration

Challenge

Medicines360, a nonprofit pharmaceutical company, was facing challenges in controlling and securely sharing regulated content among its geographically dispersed teams and partners. The company was heavily reliant on email, file share, and a paper-based system, which made it difficult for remote employees or contractors to access standard operating procedures (SOPs) or other regulated documents. As the company was transitioning from research and development to launching and commercializing its first product, it was struggling with complex and inefficient processes for developing, reviewing, approving, and tracking training of controlled documents. Without a single document management system that was easily accessible from anywhere, the company lacked a consistent and efficient way to distribute controlled content and track SOP training to ensure compliance.

About Customer

Medicines360 is an innovative, global nonprofit, women’s health pharmaceutical company with a mission of expanding access to quality medicines, regardless of socioeconomics, insurance coverage, or geographic location. The U.S. Food and Drug Administration (FDA) recently approved Medicines360’s Liletta™ (levonorgestrel), a hormonal intrauterine device (IUD). The company is now ramping up commercialization of its new product. Medicines360 relies heavily on geographically dispersed teams and partners. With only email, file share, and a paper-based system, it was challenging to control and securely share regulated content. It was also not feasible for remote employees or contractors to come into the office when they needed to refer to a standard operating procedure (SOP) or other regulated document.

Solution

Medicines360 implemented Veeva Vault QualityDocs, a cloud-based, advanced content management technology. The solution met all the company's requirements, including an intuitive user interface, robust audit trail, compliant electronic signatures, and validation support. Vault QualityDocs is accessible from any major web browser, allowing users to easily learn and access the application from anywhere. The solution also provides true multitenant cloud and validation-ready software updates, ensuring that Medicines360 is always on the latest release. The ability to seamlessly view PDF documents removed the infrastructure complexity and connection challenges experienced with other applications. The implementation of Vault QualityDocs was completed faster than expected due to its native life sciences-specific functionality, including preconfigured quality workflows and document taxonomy. The solution's cross-browser, cross-platform functionality allows Medicines360 to easily collaborate with different functional areas and share best practices in real time.

Impact #1	Increased Efficiency: Managing document and workflows electronically with Vault QualityDocs keeps documents visible, no matter where the content is in its lifecycle, and maintains strict version control, regardless of who has access or makes changes.
Impact #2	Improved Productivity: Having access to critical content on any device, anywhere, and at any time leads to more productive employees.
Impact #3	Easier Training: Managers can easily monitor training progress and rectify any problems quickly. Reminders on re-training are also built-in to ensure users are always up to date on SOPs.

Impact #1

Increased Efficiency: Managing document and workflows electronically with Vault QualityDocs keeps documents visible, no matter where the content is in its lifecycle, and maintains strict version control, regardless of who has access or makes changes.

Impact #2

Improved Productivity: Having access to critical content on any device, anywhere, and at any time leads to more productive employees.

Impact #3

Easier Training: Managers can easily monitor training progress and rectify any problems quickly. Reminders on re-training are also built-in to ensure users are always up to date on SOPs.

Benefit #1	The implementation of Vault QualityDocs was completed in just four weeks, significantly faster than the expected one-year project.
Benefit #2	80% of the company's quality management documents were fully migrated and managed exclusively in Vault QualityDocs within eight weeks of implementation.

Benefit #1

The implementation of Vault QualityDocs was completed in just four weeks, significantly faster than the expected one-year project.

Benefit #2

80% of the company's quality management documents were fully migrated and managed exclusively in Vault QualityDocs within eight weeks of implementation.

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Overview

Medicines360 Takes Control of Regulated Content with Vault QualityDocs

Operational Impact

Quantitative Benefit