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

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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 functinoal 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.

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.

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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

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

Patient Support Programs in India: Overcoming Barriers with Healthcare Access

November 19, 2024

Patient Support Programs in India: Overcoming Barriers with Healthcare Access

Explore India's healthcare challenges, including affordability, rural access issues, and the role of Patient Support Programs in improving medication access.

Checklist for Building a Successful Risk Evaluation and Mitigation Strategy (REMS) Program

November 18, 2024

Checklist for Building a Successful Risk Evaluation and Mitigation Strategy (REMS) Program

Build a successful Risk Evaluation and Mitigation Strategy (REMS) program to ensure drug safety and regulatory compliance with our comprehensive checklist.

Meet the Expert: Andrew Bright

November 14, 2024

Meet the Expert: Andrew Bright

Discover how Andrew Bright, Senior Consultant, Product Lifecycle Management at ProPharma, manages complex manufacturing and transfer projects

ProPharma Appoints Brian Tuttle as Chief Financial Officer

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.

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 Names Dawn Sherman Chief Executive Officer

September 30, 2024

ProPharma Names Dawn Sherman Chief Executive Officer

Dawn Sherman rejoins ProPharma as CEO, bringing nearly 30 years of industry experience to lead the regulatory, clinical, and compliance services provider.

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.

ProPharma Receives 2024 CRO Leadership Award

June 13, 2024

ProPharma Receives 2024 CRO Leadership Award

ProPharma wins 2024 CRO Leadership Award for exceeding expectations in key categories, solidifying its position as a top global research consulting organization in the life sciences industry.

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

ProPharma Appoints Brian Tuttle as Chief Financial Officer

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.

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 Names Dawn Sherman Chief Executive Officer

September 30, 2024

ProPharma Names Dawn Sherman Chief Executive Officer

Dawn Sherman rejoins ProPharma as CEO, bringing nearly 30 years of industry experience to lead the regulatory, clinical, and compliance services provider.

Previous Post Arrow Next Post Arrow
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.

ProPharma Receives 2024 CRO Leadership Award

June 13, 2024

ProPharma Receives 2024 CRO Leadership Award

ProPharma wins 2024 CRO Leadership Award for exceeding expectations in key categories, solidifying its position as a top global research consulting organization in the life sciences industry.

Previous Award Arrow Next Award Arrow
Patient Support Programs in India: Overcoming Barriers with Healthcare Access

November 19, 2024

Patient Support Programs in India: Overcoming Barriers with Healthcare Access

Explore India's healthcare challenges, including affordability, rural access issues, and the role of Patient Support Programs in improving medication access.

Checklist for Building a Successful Risk Evaluation and Mitigation Strategy (REMS) Program

November 18, 2024

Checklist for Building a Successful Risk Evaluation and Mitigation Strategy (REMS) Program

Build a successful Risk Evaluation and Mitigation Strategy (REMS) program to ensure drug safety and regulatory compliance with our comprehensive checklist.

Meet the Expert: Andrew Bright

November 14, 2024

Meet the Expert: Andrew Bright

Discover how Andrew Bright, Senior Consultant, Product Lifecycle Management at ProPharma, manages complex manufacturing and transfer projects

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