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.
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.
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 functional 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.
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 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
January 29, 2026
Preparing for eCTD 4.0: What FDA Submitters Need to Know
eCTD 4.0 is coming. Learn what’s changing, why early planning matters, and how FDA submitters can prepare for a smooth transition.
January 26, 2026
Elevating Laboratory Compliance in 2026: How Pharma & Biotech Navigate GLP, Outs...
Discover how pharmaceutical and biotech companies can elevate laboratory compliance in 2026 through GLP, strategic outsourcing, and robust quality assurance.
January 27, 2026
ProPharma Sets the Gold Standard in Sustainability with SBTi-Approved Net-Zero T...
ProPharma’s greenhouse gas reduction targets are validated by SBTi, aligning with the Net-Zero Standard and a commitment to reach net-zero by 2050.
December 11, 2025
ProPharma Expands Operations with New Office in Hyderabad
ProPharma expands with a new office in Hyderabad, enhancing innovation and growth in regulatory, clinical, and compliance services for the life sciences industry.
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 9, 2024
ProPharma Receives 2024 CPHI Regulatory and Compliance Award
ProPharma wins CPHI Pharma Award for excellence in regulatory and compliance innovation, enhancing efficiency and accelerating market access for life-saving therapies.
January 30, 2026
High-Volume Global Pharmacovigilance Onboarding
A global biotechnology sponsor faced a sudden surge in pharmacovigilance demand, with monthly ICSR volumes exceeding 30,000 cases across multiple regions. Limited internal capacity, tight onboarding...
January 28, 2026
Stabilizing High-Volume Legal Case Processing Through Structured Governance
ProPharma’s client faced escalating operational risk as high-volume legal case documentation overwhelmed their prior vendor. Thousands of documents, missed regulatory timelines, and a surge of...
March 12, 2026
Mastering the PSMF: The Pillar of Inspection Readiness for MAHs, LPPVs & QPPVs
Uncover the intricacies of Pharmacovigilance System Master File (PSMF) management and explore proven strategies to ensure inspection readiness, effective MAH oversight, and regulatory compliance...
February 17, 2026
Evolving FDA Expectations: How High-Functioning MLR Teams Manage Risk in 2026
With promotional scrutiny increasing around areas such as social media, influencer campaigns, direct-to-consumer (DTC) messaging, and data-driven claims, the session walks through the characteristics...
News & Insights