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...
Configuration
Our consultants expertly tailor workflows, reports, page layouts, and fields/objects to your business requirements, thereby ensuring effective document control processes, CAPA and...
Data 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...
Controlled 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...
QMS 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...
Change 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.
QMS 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.
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.
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...
An Inspection-Ready QMS Accelerates Product Introductions in Europe
Accessing new market is in the European Union can be a challenge especially when having to navigate both specific country and general European regulation. Read how ProPharma used their deep...
News & Insights
July 31, 2025
Pros and Cons of Working with a CRO
Explore the pros and cons of working with a Contract Research Organization (CRO) and how ProPharma sets a new standard in clinical development success.
July 28, 2025
Understanding PADER: A Key Pharmacovigilance Requirement for the U.S. Market
Learn about PADER, a crucial pharmacovigilance requirement for U.S. drug safety monitoring, and how it differs from PSUR in ensuring compliance and patient safety. Summarizing the main point of the...
July 25, 2025
Understanding the Roles of LPPV, QPPV, and the PSMF in Pharmacovigilance: A Guid...
Learn about the crucial roles of QPPV, LPPV, and PSMF in ensuring effective pharmacovigilance and regulatory compliance for Marketing Authorization Holders (MAHs).
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News & Insights
July 8, 2025
ProPharma Appoints Marshall Florence, Former FDA Labeling Expert, as Vice Presid...
ProPharma appoints former FDA labeling expert as VP, Labeling & Strategy, enhancing strategic labeling, promotional review, and regulatory consulting expertise to accelerate drug development and...
January 31, 2025
ProPharma Recognized for AI Excellence at ECCCSA
ProPharma wins Silver at ECCCSA for AI innovation in Medical Information, enhancing efficiency and quality in delivering accurate medical information.
October 21, 2024
ProPharma Appoints Brian Tuttle as Chief Financial Officer
ProPharma appoints Brian Tuttle as CFO to drive financial strategy and accelerate global growth, leveraging his 20 years of life sciences industry experience.
