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 functinoal 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
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.
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.
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.
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.
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.
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.
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...
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...
News & Insights