Quality Management Systems (QMS)

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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

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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...

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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 implementation experience to keep cross-functions on track. 

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Configuration

Our consultants expertly tailor workflows, reports, page layouts, and fields/objects to your business requirements, thereby ensuring effective document control processes, CAPA and...

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Configuration

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.

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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...

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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 maintain compliance with regulations and company guidelines. 

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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...

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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 to both achieve go-live and enable users to work compliantly in your system. 

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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...

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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 quickly, but also increases user adoption of your eQMS investment. 

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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.

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.

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QMS Strategy & Business Optimization

QMS Strategy & Business Optimization

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Quality & Compliance

Quality & Compliance

Compliance

Validation

Validation

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Managed Services

Managed Services

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. 

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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. 

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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.

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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.

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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.

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SureQMS (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...

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SureQMS (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.

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QMS 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.

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QMS (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...

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QMS (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.

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Vault 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,...

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Vault 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.

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Experienced Quality Management System Support

ProPharma's R&D Technology team has the experience and expertise to help you from vendor selection through change management. 

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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

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

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

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

Preparing for eCTD 4.0: What FDA Submitters Need to Know

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.

Elevating Laboratory Compliance in 2026: How Pharma & Biotech Navigate GLP, Outsourcing, and Quality Assurance

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.

2025 Year in Review: Regulatory Shake-Ups Reshaping Pharma Promotion in 2026

January 14, 2026

2025 Year in Review: Regulatory Shake-Ups Reshaping Pharma Promotion in 2026

Explore 2025's FDA enforcement trends, OPDP changes, and evolving guidance shaping pharma advertising, MLR review, and compliance strategies for 2026.

ProPharma Sets the Gold Standard in Sustainability with SBTi-Approved Net-Zero Targets

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.

ProPharma Expands Operations with New Office in Hyderabad

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.

ProPharma Welcomes Dan Ryan as President of Clinical Research Solutions

December 4, 2025

ProPharma Welcomes Dan Ryan as President of Clinical Research Solutions

ProPharma taps Daniel Ryan as President of Clinical Research Solutions, strengthening its clinical trial management leadership and expanding its FSP Solutions.

ProPharma Recognized for AI Excellence at ECCCSA

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.

ProPharma Receives 2024 CPHI Regulatory and Compliance Award

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.

ProPharma Honored in the 2024 Clinical Trials Excellence Awards

September 24, 2024

ProPharma Honored in the 2024 Clinical Trials Excellence Awards

ProPharma honored with Clinical Trials Excellence Award 2024, recognizing their outstanding contributions in the pharmaceutical industry.

Case Study High-Volume Global Pharmacovigilance Onboarding - ProPharma

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...

Case Study Stabilizing High-Volume Legal Case Processing Through Structured Governance - ProPharma

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...

Case Study Overcoming Operational Hurdles in a High-Stakes Stroke Trial - ProPharma

December 15, 2025

Overcoming Operational Hurdles in a High-Stakes Stroke Trial

Argenica Therapeutics’ Phase 2 acute ischaemic stroke trial faced the challenges of unpredictable patient presentation, narrow treatment windows, and demanding emergency care environments. This...

Mastering the PSMF: The Pillar of Inspection Readiness for MAHs, LPPVs & QPPVs

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...

Evolving FDA Expectations: How High-Functioning MLR Teams Manage Risk in 2026

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...

Scaling High-Quality Medical Information Through Offshoring

February 11, 2026

Scaling High-Quality Medical Information Through Offshoring

Navigate the complexities of offshoring Medical Information and explore proven strategies to ensure consistent quality, regulatory compliance, and seamless global execution. Join us for an...

News & Insights

Preparing for eCTD 4.0: What FDA Submitters Need to Know

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.

Elevating Laboratory Compliance in 2026: How Pharma & Biotech Navigate GLP, Outsourcing, and Quality Assurance

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.

2025 Year in Review: Regulatory Shake-Ups Reshaping Pharma Promotion in 2026

January 14, 2026

2025 Year in Review: Regulatory Shake-Ups Reshaping Pharma Promotion in 2026

Explore 2025's FDA enforcement trends, OPDP changes, and evolving guidance shaping pharma advertising, MLR review, and compliance strategies for 2026.

Previous Post Arrow Next Post Arrow
ProPharma Sets the Gold Standard in Sustainability with SBTi-Approved Net-Zero Targets

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.

ProPharma Expands Operations with New Office in Hyderabad

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.

ProPharma Welcomes Dan Ryan as President of Clinical Research Solutions

December 4, 2025

ProPharma Welcomes Dan Ryan as President of Clinical Research Solutions

ProPharma taps Daniel Ryan as President of Clinical Research Solutions, strengthening its clinical trial management leadership and expanding its FSP Solutions.

Previous Post Arrow Next Post Arrow
ProPharma Recognized for AI Excellence at ECCCSA

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.

ProPharma Receives 2024 CPHI Regulatory and Compliance Award

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.

ProPharma Honored in the 2024 Clinical Trials Excellence Awards

September 24, 2024

ProPharma Honored in the 2024 Clinical Trials Excellence Awards

ProPharma honored with Clinical Trials Excellence Award 2024, recognizing their outstanding contributions in the pharmaceutical industry.

Previous Award Arrow Next Award Arrow
Case Study High-Volume Global Pharmacovigilance Onboarding - ProPharma

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...

Case Study Stabilizing High-Volume Legal Case Processing Through Structured Governance - ProPharma

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...

Case Study Overcoming Operational Hurdles in a High-Stakes Stroke Trial - ProPharma

December 15, 2025

Overcoming Operational Hurdles in a High-Stakes Stroke Trial

Argenica Therapeutics’ Phase 2 acute ischaemic stroke trial faced the challenges of unpredictable patient presentation, narrow treatment windows, and demanding emergency care environments. This...

Previous Resource Arrow Next Resource Arrow
Mastering the PSMF: The Pillar of Inspection Readiness for MAHs, LPPVs & QPPVs

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...

Evolving FDA Expectations: How High-Functioning MLR Teams Manage Risk in 2026

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...

Scaling High-Quality Medical Information Through Offshoring

February 11, 2026

Scaling High-Quality Medical Information Through Offshoring

Navigate the complexities of offshoring Medical Information and explore proven strategies to ensure consistent quality, regulatory compliance, and seamless global execution. Join us for an...

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