quality management systems (QMS)

Laboratory technician using dropper with a test tube

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

RDSolutionsConsulting

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 More

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. 

Read Less
promotional-review

Configuration

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

Read More

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.

Read Less
expert-witness

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...

Read More

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. 

Read Less
medical-writing

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...

Read More

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. 

Read Less
medical-information

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...

Read More

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. 

Read Less
RDTechnology

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 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.

Read Less
ResearchPlatforms

QMS Strategy & Business Optimization

QMS Strategy & Business Optimization

quality-compliance

Quality & Compliance

Quality & Compliance

compliance

Validation

Validation

computer-system-validation

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. 

Group of business professionals working at a conference table

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. 

Group of healthcare professionals in lab-coats pointing to a test tube

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.

High-tech manufacturing equipment

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.

Tablet device displaying various data graphs and charts

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 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 Less

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...

Read More

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.

Read Less

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.

Read Less

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...

Read More

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.

Read Less

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,...

Read More

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.

Read Less

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. 

Hand typing on keyboard with workflow diagram overlay

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...

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

EU Regulatory Sciences EU Pharmaceutical Legislation Reform: Where Are We Now?

March 26, 2024

EU Pharmaceutical Legislation Reform: Where Are We Now?

On April 26, 2023, the European Commission proposed a new package of pharmaceutical legislation1 to revise many of the currently applicable Regulations. Background This revision is considered by many...

Medical Information Privacy PIPL China Understanding PIPL: Compliance and Implementation Challenges

March 25, 2024

Understanding PIPL: Compliance and Implementation Challenges

What is PIPL? Personal Information Protection Law (PIPL) was approved in China on August 20, 2021. It was the first comprehensive data protection legislation in the region. The Law entered into...

LPPV PSMF QPPV Pharmacovigilance Achieving Success with Regulatory Intelligence in Pharmacovigilance

March 25, 2024

Achieving Success with Regulatory Intelligence in Pharmacovigilance

What is Regulatory Intelligence in Pharmacovigilance? In Pharmacovigilance (PV), Regulatory Intelligence involves the collection and analysis of publicly accessible PV regulatory guidelines and...

Press Releases ProPharma Announces Changes to Its Executive Leadership Team

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...

Press Releases ProPharma Announces the Appointment of Vicki Gashwiler as Vice President of Clinical Operations, Medical Technology

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...

Company News Press Releases Innovation and the Black Swan Prodigy Whitepaper

January 4, 2024

Innovation and the Black Swan Prodigy Whitepaper

Check out our comprehensive whitepaper, "Innovation and the Black Swan: the Imperative of AI-enabled clinical research," for an in-depth look at how embracing AI-enabled tools and technologies is...

Press Releases Awards EY Announces Michael Stomberg as an Entrepreneur Of the Year® 2023 National Finalist

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,...

Press Releases Awards ProPharma Group Recognized by Everest Group as a Major Contender in Life Sciences Operations PEAK Matrix® Assessment 2023

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...

Press Releases Awards ProPharma Recognized by Inc. 5000 List of America’s Fastest-Growing Companies

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...

Infographic The Cost of Poor Project Management - ProPharma

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...

Infographic Successfully Passing MHRA Inspections for Overseas Manufacturing Sites - ProPharma

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...

Infographic Navigating the Generic Drug Application and Approval Process - ProPharma

October 4, 2021

Navigating the Generic Drug Application and Approval Process

Navigating the generic drug application and approval process can be challenging. From pre-filing through post-approval, find out exactly what needs to be done for your Abbreviated New Drug...

News & Insights

Press Releases ProPharma Announces Changes to Its Executive Leadership Team

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...

Press Releases ProPharma Announces the Appointment of Vicki Gashwiler as Vice President of Clinical Operations, Medical Technology

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...

Company News Press Releases Innovation and the Black Swan Prodigy Whitepaper

January 4, 2024

Innovation and the Black Swan Prodigy Whitepaper

Check out our comprehensive whitepaper, "Innovation and the Black Swan: the Imperative of AI-enabled clinical research," for an in-depth look at how embracing AI-enabled tools and technologies is...

Previous Post Arrow Next Post Arrow
%}
Press Releases Awards EY Announces Michael Stomberg as an Entrepreneur Of the Year® 2023 National Finalist

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,...

Press Releases Awards ProPharma Group Recognized by Everest Group as a Major Contender in Life Sciences Operations PEAK Matrix® Assessment 2023

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...

Press Releases Awards ProPharma Recognized by Inc. 5000 List of America’s Fastest-Growing Companies

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...

Previous Award Arrow Next Award Arrow
EU Regulatory Sciences EU Pharmaceutical Legislation Reform: Where Are We Now?

March 26, 2024

EU Pharmaceutical Legislation Reform: Where Are We Now?

On April 26, 2023, the European Commission proposed a new package of pharmaceutical legislation1 to revise many of the currently applicable Regulations. Background This revision is considered by many...

Medical Information Privacy PIPL China Understanding PIPL: Compliance and Implementation Challenges

March 25, 2024

Understanding PIPL: Compliance and Implementation Challenges

What is PIPL? Personal Information Protection Law (PIPL) was approved in China on August 20, 2021. It was the first comprehensive data protection legislation in the region. The Law entered into...

LPPV PSMF QPPV Pharmacovigilance Achieving Success with Regulatory Intelligence in Pharmacovigilance

March 25, 2024

Achieving Success with Regulatory Intelligence in Pharmacovigilance

What is Regulatory Intelligence in Pharmacovigilance? In Pharmacovigilance (PV), Regulatory Intelligence involves the collection and analysis of publicly accessible PV regulatory guidelines and...

Previous Post Arrow Next Post Arrow
Infographic The Cost of Poor Project Management - ProPharma

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...

Infographic Successfully Passing MHRA Inspections for Overseas Manufacturing Sites - ProPharma

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...

Infographic Navigating the Generic Drug Application and Approval Process - ProPharma

October 4, 2021

Navigating the Generic Drug Application and Approval Process

Navigating the generic drug application and approval process can be challenging. From pre-filing through post-approval, find out exactly what needs to be done for your Abbreviated New Drug...

Previous Resource Arrow Next Resource Arrow