quality management systems (QMS)
ProPharma QMS Experience and Expertise
With the advancement of eQMS, paper-based processes are becoming obsolete. For many companies, however, the current challenge lies in correctly using a QMS to take appropriate action and prevent avoidable delays. ProPharma's R&D Technology team understands the criticality of selecting the right solution and excels in aligning your companies' needs with regulations and GxP system best practices.
Our comprehensive approach and expert knowledge ensure that your organization is set up for long-term success. Our experienced R&D Technology consultants have extensive experience various QMS areas.
QMS Strategic Consulting
Project Management
We streamline your project by partnering with you and your chosen vendor every step of the way. While your team focuses on bringing products to market, we bring in years of...
Read MoreProject Management
We streamline your project by partnering with you and your chosen vendor every step of the way. While your team focuses on bringing products to market, we bring in years of implementation experience to keep cross-functions on track.
Read LessConfiguration
Our consultants expertly tailor workflows, reports, page layouts, and fields/objects to your business requirements, thereby ensuring effective document control processes, CAPA and...
Read MoreConfiguration
Our consultants expertly tailor workflows, reports, page layouts, and fields/objects to your business requirements, thereby ensuring effective document control processes, CAPA and deviation management, vendor & audit tracking and continuous improvement initiatives.
Read LessData Governance and Migration
From data cleansing to transformation, ProPharma ensures your content is migrated correctly the first time. We also advise on long-term data governance models to...
Read MoreData Governance and Migration
From data cleansing to transformation, ProPharma ensures your content is migrated correctly the first time. We also advise on long-term data governance models to maintain compliance with regulations and company guidelines.
Read LessControlled Document Creation
(SOPs, Work Instructions and Job Aids)
Relieve the burden of authoring procedures and how-to's. ProPharma leverages proprietary SOPs, Job Aids, and governance templates...
Read MoreControlled Document Creation
(SOPs, Work Instructions and Job Aids)
Relieve the burden of authoring procedures and how-to's. ProPharma leverages proprietary SOPs, Job Aids, and governance templates to both achieve go-live and enable users to work compliantly in your system.
Read LessQMS Training
In collaboration with your team, ProPharma creates a curriculum that suits your timeline and desired formats. Focused training development not only gets your staff up to speed more...
Read MoreQMS Training
In collaboration with your team, ProPharma creates a curriculum that suits your timeline and desired formats. Focused training development not only gets your staff up to speed more quickly, but also increases user adoption of your eQMS investment.
Read LessChange Management
As we guide you through risk-based assessments of your new/upgraded system, ProPharma helps ensure that your digital transformation is successfully enabled and clearly documented.
Read MoreChange Management
As we guide you through risk-based assessments of your new/upgraded system, ProPharma helps ensure that your digital transformation is successfully enabled and clearly documented.
Read LessQMS Strategy & Business Optimization
System Selection
Assess different vendors against your organization’s functional requirements through our tried-and-true process. We collaborate with you during demos, reference checks, and RFPs to ensure you are empowered to select the best fit-for-use software.
Process Development
Revolutionizing your technology landscape is a complex undertaking. ProPharma helps you map existing processes to system capabilities, ensuring that organization-level plans are harmonized with functional area needs.
Quality & Compliance
Audits, Consulting, and Inspections
We've supported 200+ client audits in evaluating quality and compliance systems, whether internal or vendor-related. Our experts are well-versed in third-party audits, inspection readiness, QMS gap assessments, data integrity assessments, and more.
Staff Augmentation
ProPharma matches best-in-class talent to your organization’s scope of work. Our functinoal service provider (FSP) model enables your organization to quickly address staffing needs while we take care of sourcing and screening.
Validation
Validation Coordination
From validation planning to conclusion reports, our resources ensure your validation strategy rigorously traces and tests every requirement in case of regulatory audits. We assist with development of the following deliverables:
- Validation Plan
- Functional Requirement Specifications (FRS)
- Trace Matrix (TM)
- Installation Qualification (IQ)
- Operational Qualification (OQ)
- Performance Qualification (PQ)
- User Requirement Specifications (URS)
- Change Controls
- Validation Summary Report (VSR)
User Acceptance Testing
Make your system adoption as seamless as possible by letting our validation specialists handle script authoring and execution. We work with the vendor to ensure your entire system is fully validated.
Managed Services
System Administration
From user access management to data governance, our resources work closely with your software vendor and Business Process Owners to facilitate day-to-day administration activities.
Release Management
Consult with us to plan, test, and deploy releases to keep your system up-to-date with the latest and greatest features. While your organization determines the level of support needed, we provide white-glove treatment to make your digital transformation quality-driven and cost-effective.
System Optimization
Once employees use your system, you may discover unexpected inefficiencies. Our team analyzes possible solutions and customizes your system to better suit your business needs.
QMS Software Vendors
eQMS (Qualio)
Lean, streamlined platform that works well for companies on short implementation timelines and start-ups. Qualio offers modules for managing risk, training, change controls, and more.
Read MoreeQMS (Qualio)
Lean, streamlined platform that works well for companies on short implementation timelines and start-ups. Qualio offers modules for managing risk, training, change controls, and more.
Read LessSureQMS (SureClinical)
Suitable for small to medium-sized businesses, SureQMS not only covers standard quality processes, but also features an audit wizard and Smart Quality™ technology to...
Read MoreSureQMS (SureClinical)
Suitable for small to medium-sized businesses, SureQMS not only covers standard quality processes, but also features an audit wizard and Smart Quality™ technology to proactively suggest corrective quality actions.
Read LessQMS Xpress (Dot Compliance)
Pre-configured, validated system built on Salesforce platform. The end-to-end platform allows for scalable growth.
QMS Xpress (Dot Compliance)
Pre-configured, validated system built on Salesforce platform. The end-to-end platform allows for scalable growth.
Read LessQMS (MasterControl)
Cloud-based quality and compliance software that enables life sciences companies to control quality processes throughout the product development life cycle. Scalable for small...
Read MoreQMS (MasterControl)
Cloud-based quality and compliance software that enables life sciences companies to control quality processes throughout the product development life cycle. Scalable for small businesses up to enterprise customers.
Read LessVault QMS (Veeva Systems)
A cloud-based application, Vault QMS has been adopted by 100+ organizations and can be integrated with other modules in Veeva's Quality Suite (QualityDocs, Batch Release,...
Read MoreVault QMS (Veeva Systems)
A cloud-based application, Vault QMS has been adopted by 100+ organizations and can be integrated with other modules in Veeva's Quality Suite (QualityDocs, Batch Release, and Vault Training).
Learn more about our Veeva Vault Support Services.
Read LessExperienced Quality Management System Support
ProPharma's R&D Technology team has the experience and expertise to help you from vendor selection through change management.
What are Quality Management Systems (QMS)?
Quality Management is the set of processes that enable delivery of high-quality products while maintaining regulatory compliance. Its purpose is to ensure that all organizational processes are conducted in a documented, consistent, and controlled manner.
Read more frequently asked questions about quality management systems.
QMS Resources
Navigating QMS Requirements from a Medical Device Perspective
Having a different number of pharmaceutical classified products in your portfolio provides a challenge in EU. As distribution and sales of MD products are under MDR, while pharmaceuticals are under...
How to Successfully Launch Products with QMS and QP Certification
Reaching patients in the EU with needed medicinal products is a complex undertaking that not only requires knowledge of varied regulatory landscapes, companies must also man, the services of a...
News & Insights
April 24, 2024
The Trifecta of Promotional Review: What is a PRC & What do They Do?
The mystique of PRC unveiled – what is it and why you need it to assure successful promotional review. You have received approval from the regulators. You have a dynamic sales force in place. They...
April 23, 2024
Meet the Expert: Sarah Giorgio
Our "Meet the Expert" series introduces you to our team of experts around the world. This "behind the curtain" view will help you get to know who we are on a professional and personal level, and...
April 18, 2024
ProPharma Now Certified as Medidata Rave EDC Accredited Partner
Leading Research Consulting Organization (RCO) Receives Medidata Accreditation for the RAVE EDC Module, Enhancing Clinical Trial Efficiency and Data Integrity for sponsors. RALEIGH, April 18, 2024 –...
April 10, 2024
ProPharma Announces Changes to Its Executive Leadership Team
Strategic Leadership Appointments to Propel Global Growth RALEIGH, April 10, 2024 – ProPharma, the leading global provider of regulatory, clinical, and compliance services for the life sciences...
January 24, 2024
ProPharma Announces the Appointment of Vicki Gashwiler as Vice President of Clinical Operations, Medical Technology
RALEIGH, January 24, 2024, ProPharma Group (ProPharma), the leading global provider of regulatory, clinical, and compliance services for the life sciences industry, and a portfolio company of Odyssey...
November 27, 2023
EY Announces Michael Stomberg as an Entrepreneur Of the Year® 2023 National Finalist
Entrepreneur Of The Year® celebrates ambitious entrepreneurs who are building a better world. RALEIGH, NC, November 27, 2023 – Ernst & Young LLP (EY US) today announced that Chief Executive Officer,...
October 11, 2023
ProPharma Group Recognized by Everest Group as a Major Contender in Life Sciences Operations PEAK Matrix® Assessment 2023
Raleigh, NC, October 11, 2023: ProPharma Group (ProPharma), the leading global provider of regulatory, clinical and compliance services for the life sciences industry, and a portfolio company of...
August 15, 2023
ProPharma Recognized by Inc. 5000 List of America’s Fastest-Growing Companies
ProPharma Recognized on the Inc. 5000 List of America’s Fastest-Growing Companies After a year of Growth and Innovation, ProPharma achieved its highest rank in 20+ year history. RALEIGH, NC, August...
June 10, 2022
The Cost of Poor Project Management
Project Management isn’t for the faint of heart. There is a shockingly high rate of project failure… but on the other hand, great project management can be a key differentiator that leads a company...
August 31, 2022
Successfully Passing MHRA Inspections for Overseas Manufacturing Sites
ProPharma offers GMP and GDP compliance services from clinical development to commercial distribution of the products' lifecycle. ProPharma’s Compliance and Quality team completed the first on-site...
News & Insights
April 18, 2024
ProPharma Now Certified as Medidata Rave EDC Accredited Partner
Leading Research Consulting Organization (RCO) Receives Medidata Accreditation for the RAVE EDC Module, Enhancing Clinical Trial Efficiency and Data Integrity for sponsors. RALEIGH, April 18, 2024 –...
January 24, 2024
ProPharma Announces the Appointment of Vicki Gashwiler as Vice President of Clinical Operations, Medical Technology
RALEIGH, January 24, 2024, ProPharma Group (ProPharma), the leading global provider of regulatory, clinical, and compliance services for the life sciences industry, and a portfolio company of Odyssey...
November 27, 2023
EY Announces Michael Stomberg as an Entrepreneur Of the Year® 2023 National Finalist
Entrepreneur Of The Year® celebrates ambitious entrepreneurs who are building a better world. RALEIGH, NC, November 27, 2023 – Ernst & Young LLP (EY US) today announced that Chief Executive Officer,...
October 11, 2023
ProPharma Group Recognized by Everest Group as a Major Contender in Life Sciences Operations PEAK Matrix® Assessment 2023
Raleigh, NC, October 11, 2023: ProPharma Group (ProPharma), the leading global provider of regulatory, clinical and compliance services for the life sciences industry, and a portfolio company of...
August 15, 2023
ProPharma Recognized by Inc. 5000 List of America’s Fastest-Growing Companies
ProPharma Recognized on the Inc. 5000 List of America’s Fastest-Growing Companies After a year of Growth and Innovation, ProPharma achieved its highest rank in 20+ year history. RALEIGH, NC, August...
April 24, 2024
The Trifecta of Promotional Review: What is a PRC & What do They Do?
The mystique of PRC unveiled – what is it and why you need it to assure successful promotional review. You have received approval from the regulators. You have a dynamic sales force in place. They...