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Integrated EQMS for Compounded Drugs

Explore how a next-generation, AI powered EQMS empowers compounded drugs businesses to maintain the required balance of artistry and science—customized care built on the foundation of quality and safety. It simplifies the complexities of end-to-end quality management through centralized processes, enhance traceability, and automate compliance with global standards like cGMP and ISO 9001. Explore the capabilities of Qualityze EQMS for Compounded Drugs today!

QMS for Compounded Drugs Industry

Transforming the Standards of Compounded Drugs Quality Management

When it comes to compounded drugs, there is no room for error. Every dose, every formulation, and every process must meet the highest standards of quality, sterility, and regulatory compliance. [Your Company Name] is your trusted partner in transforming these challenges into opportunities for growth. With our integrated quality management platform, you can manage sterility risks, ensure robust documentation, and maintain compliance with applicable regulations. Experience a new era of efficiency, safety, and patient-centered care with solutions designed specifically for the complexities of compounding.

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The Qualityze Difference Empowers You To:

Customize Patient-Specific Treatments with Precision

Leverage configurable workflows to ensure the accuracy and consistency of personalized formulations. Qualityze enables seamless documentation and monitoring of patient-specific compounds, minimizing the risk of errors in dosage and ingredients.

Ensure Raw Material Quality and Supplier Compliance

Streamline supplier qualification and ongoing assessments with Qualityze's Supplier Quality Management module. Monitor raw material quality and ensure compliance with pharmacopeial standards for every batch of compounded drugs.

Enhance Batch Documentation and Traceability

Centralize and standardize batch record management with Qualityze's cloud-based solution. Effortlessly track ingredients, processes, and patient prescriptions while ensuring data integrity and traceability for audits and inspections.

Develop Staff Competency with Role-Based Training

Facilitate specialized training for compounding staff with integrated training management tools. Ensure continuous competency in handling sterile and hazardous drugs through role-based training plans and certification tracking.

Safeguard Against Risks in Hazardous Drug Handling

Mitigate risks in handling hazardous drugs with workflows aligned to USP <800> standards. Qualityze ensures the implementation of advanced safety measures, including negative-pressure environments and PPE tracking.

Streamline Adverse Event Reporting

Capture, analyze, and report adverse events seamlessly with Qualityze's centralized incident management module. Ensure rapid identification of patterns, effective root cause analysis, and regulatory compliance for adverse event reporting.

Standard/RegulationDescription
ISO Standards
ISO 9001General Quality Management System Requirements
ISO 31000Risk Management Principles and Guidelines
ISO 17025General Requirements for the Competence of Testing and Calibration Laboratories
ISO 15189Quality and Competence in Medical Laboratories
USP Standards
USP <795>Pharmaceutical Compounding for Non-Sterile Preparations
USP <797>Pharmaceutical Compounding for Sterile Preparations
USP <800>Handling Hazardous Drugs in Healthcare Settings
USP <825>Radiopharmaceuticals—Preparation, Compounding, Dispensing, and Repackaging
FDA Regulations
21 CFR Part 11Electronic Records and Signatures
21 CFR Part 210/211Current Good Manufacturing Practices (cGMP) for Finished Pharmaceuticals
21 CFR Part 212cGMP for Positron Emission Tomography (PET) Drugs
FDCA Section 503APharmacy Compounding Requirements
FDCA Section 503BOutsourcing Facilities and Their Compliance Requirements
GxP Guidelines
GMPGood Manufacturing Practices: Ensuring Consistent Product Quality and Safety
GCPGood Compounding Practices: Best Practices in Pharmacy Compounding
GDPGood Distribution Practices: Maintaining Product Integrity in the Supply Chain
Pharmacovigilance Standards
ICH E2EPharmacovigilance Planning
WHO GuidelinesSafety Monitoring of Pharmaceutical Products
EMA Good Pharmacovigilance Practices (GVP)Standards for Monitoring Drug Safety
Occupational Safety Standards
OSHA Hazard Communication StandardFor Handling Hazardous Chemicals
NIOSH GuidelinesSafe Handling of Hazardous Drugs in Healthcare
Environmental Standards
EPA GuidelinesDisposal of Pharmaceutical Waste
DEA RegulationsCompliance for Controlled Substances in Compounding
Industry-Specific Guidelines
ASHP GuidelinesPharmacy Practice and Compounding Standards
PCAB Accreditation StandardsFor Pharmacies Engaged in Compounding
NABP Model Pharmacy ActGuidance for Compounding Pharmacy Operations
Global Guidelines
WHO Technical Report SeriesGuidelines on Compounding Practices
PIC/S GuidelinesHarmonizing GMP Standards for Compounding Practices

Reasons to choose Qualityze EQMS for Compounded Drugs Industry

Choosing Qualityze Enterprise Quality Management Solution will be a beneficial decision for the Compounded Drugs industry because it has

User-Friendly Interface

Simplifies usability with an intuitive design, requiring no technical expertise.

Seamless Integration

Fits perfectly with your existing systems to enhance operational efficiency.

Cloud-Based Platform

Provides secure, flexible, and anywhere-accessible data management.

Automated Upgrades

Keeps you up-to-date effortlessly with automatic version upgrades.

Configurable workflows and Fields

Adapts to your unique business processes with configurable options.

Low Implementation Costs

Delivers a cost-effective solution without compromising on performance.

Minimal Maintenance Needs

Eliminates hardware dependencies, offering easy access from any location.

Flexibility and Security

Combines robust security with cloud-based flexibility to meet dynamic needs.

AI-Powered Assistant

Offers intelligent support for proactive decision-making and streamlined workflows.

The Start of Something Amazing.

Let's start something Amazing

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Industries

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Compliance

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Client Testimonials

Qualityze Drives Innovation and Continuous Improvement with Strategic Partnership

Qualityze Drives Innovation and Continuous Improvement with Strategic Partnership

We have a Strategic Partnership with Qualityze. They have been an incredible partner in the configuration and
implementation of the eQMS software. I have participated in several system implementations across multiple platforms and Qualityze is ...

Corporate Quality Assurance Manager, Kenco Group

Excellent support shifting audits to Salesforce

I-CAR is a training organization with hundreds of instructors around the country. We regularly evaluate our instructors to provide quality and relevant education to our students. Due to rapid growth over a few years, our home-built system became i...

Manager, Quality Engineering
Excellent Quality Management Solution

Excellent Quality Management Solution

I manage training and document control. An effective document control system is among the most critical tools for
compliance in highly regulated industries like ours. Document control is essential in QA/RA environments because it
touches all...

Omron Healthcare, Inc
Qualityze For Our eQMS

Qualityze For Our eQMS

With every new product comes the anxiety of, “Will this work? Is it complicated? Will I have support, etc.?” but with
Qualityze and their team, they not only met our needs, but they also surpassed our expectations. Qualityze has pro...

Ortho8
Qualityze: A powerful product to manage all your quality needs

Qualityze: A powerful product to manage all your quality needs

Rinchem is focused on third party warehouse and transportation logistics. The growth in our company has lead to a need for a robust system that can manage multiple pillars of quality, from start to finish within the same system. We have implemente...

Application Analyst, Rinchem
The right fit and great support

The right fit and great support

For years we had managed all our documents, training, and changes manually using numerous spreadsheets and multiple applications. As our business grew, continuing with those methods was not feasible. We spent many months reviewing many different o...

Sr. Manager, Quality Systems, Cell Signaling Technology

Qualityze Organized Our Quality Processes

Our business was growing rapidly, and we needed help to get us organized, that’s when brought in the Qualityze Team. The Qualityze Team helped us execute our vision for the company and organized our processes to industry best in class standa...

Administrator, Blue Rabbit
Qualityze Our EQMS Solution

Qualityze Our EQMS Solution

As our company’s complaint volume increased, we decided that a new system would be needed to accurately track and report on our consumer complaints. After researching, we landed with Qualityze as our best EQMS vendor of choice. The Qualityze...

Sr. Compliance Analyst, AmeriSave Mortgage Corporation

We chose Qualityze for its simplicity!

Qualityze is an out-of-the-box, ready-to-use, Quality Management System. Since it runs as an independent, Cloud-based application, which is much nicer than trying to expand an expensive ERP system, muddied with a bunch of unwanted ERP features; th...

Quality Coordinator Master Tag Montague, MI
Qualityze EQMS implementation experience and features!!!

Qualityze EQMS implementation experience and features!!!

Our experience working with the Qualityze implementation and support team was extremely positive. They made sure we understood their base product and the best ways to fit the product to our business processes through configurations to enable ...

Global Quality Assurance Manager
Qualityze eQMS with Incredible Customer Service!

Qualityze eQMS with Incredible Customer Service!

Our business was faced with tight timelines to go live in a new electronic Quality Management System, and the Qualityze team made it happen! Our business has numerous complexities related to different sites operating under d...

Associate Supplier Quality Manager at ZimVie Spine

Our experience with Qualityze EQMS

From the moment we partnered with Qualityze Inc. for our Quality Management System needs, we knew we made the right choice. The system itself has transformed our quality management practices, providing us with the tools and insights we need to mai...

Daniel Boo
Qualityze our EQMS System

Qualityze our EQMS System

My team and I worked with Qualityze to implement a Complaint management solution which provided dashboards, reporting, response templates and the Documents module for policies and procedures. We completed much of the work at a very busy time. The ...

AVP of Compliance, AmeriSave Mortgage Corporation
A great choice for an eQMS!

A great choice for an eQMS!

After months of reviewing potential Electronic QMS software packages for our company we concluded that Qualityze was the clear choice for us. The task of implementing this type of system seemed quite daunting but working with the team at Qualityze...

QA Consultant, Sparrow Pharmaceuticals
Qualityze has been instrumental Partner for our QMS system

Qualityze has been instrumental Partner for our QMS system

Qualityze has been instrumental in our companies transition from ISO 9001 to IATF 16949. Auditor from our registrar and customers have been impressed by the use of the Qualityze modules. The Qualityze team is easy to work with, and helpful in find...

Vacuum Engineering and Materials
Our Experience with Qualityze Implementation.

Our Experience with Qualityze Implementation.

HBNO CO. is a relativity new company, started 7 years ago, and growing bigger year after year. In 2021, our management thought of introducing an EQMS system which could automate our existing process and move us away from a paper-based process to a...

Industrial Engineer IL, Health & Beauty Natural Oils Co., Inc
Qualityze Implementation For Fast-Paced Manufacturing

Qualityze Implementation For Fast-Paced Manufacturing

We are a rapidly growing manufacturing organization that seeks to integrate our quality system software with various other programs, including our MRP system. After months of searching the right solution and fit, we determined that the Qualityze Q...

Director of Quality Operations, Monarch Industries Limited
Qualityze has met all of our requirements.

Qualityze has met all of our requirements.

Infinity Molding and Assembly is a small custom injection molder that was using a highly paper based QMS. The search began for a new QMS software and after months of searching and previewing a few other systems we chose to more forward with Qualit...

Quality Systems Manager, Infinity Molding & Assembly
Our experience with Qualityze eQMS

Our experience with Qualityze eQMS

Over the past year Medimaps has implemented six of the Qualityze QMS modules to migrate the most relevant parts of the company’s Quality Management System to an electronic tool. The Qualityze team has been remarkable in competence and effici...

Director of Regulatory and Quality, Medimaps Group SA
Methodical and collaborative experience!

Methodical and collaborative experience!

With a small Quality Team, the implementation of Qualityze allowed us to notice drastic improvements in our workflows. Working with Qualityze has been great, and that has clearly been demonstrated with the easy transition and ease of product usage...

Quality Specialist, Cell Signaling Technology
Best Business Partner for QMS

Best Business Partner for QMS

Over the past year Rinchem has implemented several the Qualityze QMS modules to enhance our Quality department. Our Qualityze team has been excellent partners in development and customizations to meet our specific requirements. They have provided ...

QMS Document Control Coordinator, Rinchem Co. Inc.
Highly Recommend

Highly Recommend

Our company has been growing rapidly & we absolutely needed an eQMS solution immediately. Qualityze’s capabilities surpassed our wish list & the modules met our requirements. Implementation has been an ideal transition with guided as...

Chief Regulatory Office, Ortho8
Excellent Quality Management System

Excellent Quality Management System

Qualityze has made our processes much more organized. Everything is in one place, and it is easy to search and run
reports. The Qualityze team has also been extremely helpful as we implement new modules and help find ways to improve processes t...

QA Analyst, Omron Healthcare, Inc
Excellent software for document management and QA tasks

Excellent software for document management and QA tasks

In the past, our medical device company struggled to efficiently manage Quality processes such as document management, non-conformances, audits, employee trainings, customer complaints and CAPAs. After a systematic search and assessing multiple QM...

Quality Director, Garreco Dental
Incredible Value, Incredible Partner

Incredible Value, Incredible Partner

Qualityze drives value through innovation and they are quite dedicated to this. The differentiator for Qualityze is
their outstanding commitment to customer service and innovation. We could not ask for a better partner and it doesn’t hurt...

Director, Quality Assurance & Regulatory Affairs, Kenco Group
 Amazing Cloud EQMS Software!!!!

Amazing Cloud EQMS Software!!!!

After looking, viewing demos from several Quality Management Solutions, Qualityze checked off all the boxes of being cloud-based, user-friendly, and totally customizable. The Qualityze team has been very supportive and helped us every step of the ...

Sr. Manager Quality, Care/Of
Exceeded Our Strategic Goals in an Exceptionally Efficient Manner. All QMS processes in one system!!

Exceeded Our Strategic Goals in an Exceptionally Efficient Manner. All QMS processes in one system!!

We currently have multiple solutions that resulted in us having disparate quality systems to manage with multiple operational challenges. We were looking for a solution that could consolidate all our quality systems into one centralize repository....

Quality Assurance Coordinator, Scholls Wellness
Qualityze - Enterprise Quality Management Solution (EQMS)

Qualityze - Enterprise Quality Management Solution (EQMS)

Our organization selected Qualityze as our new eQMS system as our previous eQMS process includes the use of multiple systems across the business and associated costs for each. Qualityze provided us with a solution as a system that is highly c...

ZimVie Quality Director
Qualityze EQMS Implementation Experience

Qualityze EQMS Implementation Experience

My team and I were looking for an audit management system to accommodate a unique audit workflow. Working very closely with the Qualityze technical team, I can honestly say that they were always patient and provided me with clear guidance on how t...

SVP, Advisory Consulting COMPLY
Thank you Qualityze!

Thank you Qualityze!

Qualityze has tremendously helped our business fit its complicated model into an electronic quality management system. It has wonderful reporting and dashboard capabilities, as well as being totally customizable to fit our business’s needs. ...

Quality Control Associate, Care/Of
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