Qualityze

QUALITY MANAGEMENT FOR REGULATED INDUSTRIES

Quality Management Software for Compounded Drugs Industry

Move from reactive quality management to faster, more consistent, inspection-ready operations. Qualityze helps strengthen control over contamination risks, cold-chain excursions, batch variability, and regulatory requirements.

  • 21 CFR Part 11/EU GMP Annex 11 Ready
  • Risk Based Validation
  • Salesforce-Native Architecture
  • Salesforce
QMS for Compounded Drugs Industry
  • LifeMD
  • Highridge
  • The Andersons
  • Prayon
  • Grynova Consulting Group
  • Cavin Care

Trusted by quality teams across regulated industries

Read their success stories

INDUSTRY-SPECIFIC CHALLENGES

Compounded Drugs Quality Challenges, Solved

Qualityze helps Compounded Drugs companies address quality, compliance, and operational challenges by connecting people, processes, and quality data.

The challenge

Managing hazardous drugs requires strict controls across receipt, storage, compounding, cleaning, and disposal. Gaps in PPE use, containment, negative-pressure environments, etc. increase the risk of cross-contamination.

How Qualityze solves it

Qualityze QMS for Compounded Drugs connects quality and safety processes so teams can manage hazardous-drug incidents, exposure events, spills, deviations, investigations, CAPA, training, and corrective actions in one place.

SYSTEM CAPABILITIES

How Qualityze Strengthen Compounded Drugs Quality?

Qualityze QMS for compounded drugs industry is designed to provide teams with more control, traceability, and inspection readiness to manufacture complex formulations with great care.

Connected, Closed-Loop Platform

Bring environmental findings, testing results, formulation records, quality events, ingredient lots, and supplier info into one closed-loop quality system.

IdentifyTriageAssessInvestigateActVerifyLearn

The system maintains end-to-end traceability for informed release decisions.

Connected Compounded Drugs quality and supplier operations
Connected Compounded Drugs quality and supplier operations

Enterprise Quality Management System

Manage deviations, nonconformances, compounding failures, sterility problems, potency issues, OOS/OOT investigations, and CAPAs.

Connected Compounded Drugs quality and supplier operations

Product Data Management System

Maintain controlled product information, specifications, critical materials, and packaging criteria, in one secure, validated platform.

Connected Compounded Drugs quality and supplier operations

Asset Management System

Keep a log of calibration and maintenance status of the isolators, freezers, lab equipment, hoods, balances, etc.

Connected Compounded Drugs quality and supplier operations

Environmental, Health and Safety System

Manage cleanroom events, hazardous drug handling, temperature controls, and quality issues due to environmental conditions.

Supplier Relationship Management System

Establish stronger quality controls over APIs, excipients, containers, packaging suppliers, and other critical external partners.

QualifyApproveReceiveMonitorChangeCorrect
Connected Compounded Drugs quality and supplier operations

Post-Market Surveillance Management System

Manage post-market events by linking data to specific formulations, ingredients, preparatory process, suppliers, and investigations.

CaptureAssessInvestigateActTrendImprove
Connected Compounded Drugs quality and supplier operations

Built-In Continuous Improvement Tools

Use built-in, structured root cause analysis tools like 5Whys, Six Sigma, FMEA and effectiveness reviews to tighten quality controls.

DetectAnalyzePrioritizeCorrectVerifyStandardize
Connected Compounded Drugs quality and supplier operations

7

Quality, safety, product, asset, supplier, post-market vigilance and improvement management

1

Consistent information across connected records and workflows

100%

Linked actions, approvals, changes, and supporting evidence

Enterprise Visibility

Cross-site insights across teams, processes, and operations

THE SHIFT

From Reactive Quality to Proactive Control

See how Qualityze Compounded Drug Quality Management Software replaces common compliance bottlenecks with connected, traceable workflows.

Manual and disconnected Compounded Drugs quality operations

Manual · Fragmented · Risk-Prone

Formulations, ingredient records, and compounding instructions are managed across disconnected files.
Sterility, environmental, and contamination events are difficult to connect with affected preparations.
OOS, potency, and sterility failures can remain open or delay release decisions.
Training and competency records are manually tracked, increasing qualification and aseptic-practice gaps.
Complaints, recalls, and ingredient issues require manual tracing across batches and distribution records.
Controlled and proactive Compounded Drugs quality operations

Controlled · Connected · Inspection-Ready

Centralize formulations, specifications, ingredient data, and quality records in one controlled system.
Link excursions, investigations, CAPA, and affected preparations within closed-loop quality workflows.
Route failed results through investigation, impact assessment, disposition, approval, and effectiveness checks.
Automate training, competency tracking, retraining, and qualification requirements for critical compounding activities.
Maintain traceability from supplier and ingredient lot through preparation, release, complaint, and recall.

Regulatory Frameworks Qualityze Supports

U.S. COMPOUNDED DRUG QUALITY & MANUFACTURING

FDA · cGMP · ELECTRONIC RECORDS

  • FD&C Act Section 503A · Pharmacy Compounding

    Supports controlled documentation for pharmacy quality processes as per the conditions of Section 503A.

  • FD&C Act Section 503B · Outsourcing Facilities

    Supports quality processes for FDA-registered outsourcing facilities that operate under applicable cGMP requirements.

  • 21 CFR Parts 210 & 211 · Pharmaceutical cGMP

    Helps 503B outsourcing facilities manage controlled processes around components, production, laboratory controls and more.

  • 21 CFR Part 11 · Electronic Records & Signatures

    Provides a foundation for trustworthy electronic records, controlled access, audit trails, and electronic signatures.

USP COMPOUNDING QUALITY & PATIENT SAFETY

NONSTERILE · STERILE · HAZARDOUS DRUGS · QUALITY ASSURANCE

  • USP <795> · Pharmaceutical Compounding—Nonsterile Preparations

    Supports controlled processes for nonsterile compounding from formulations to preparation practices, and beyond-use dating.

  • USP <797> · Pharmaceutical Compounding—Sterile Preparations

    Supports quality processes around sterile compounding to reduce risks associated with its preparations.

  • USP <800> · Hazardous Drugs—Handling in Healthcare Settings

    Helps teams maintain controlled processes for hazardous-drug receipt, storage, compounding, dispensing, and more.

  • USP <1163> · Quality Assurance in Pharmaceutical Compounding

    Provides a quality-assurance framework covering areas such as training, SOPs, documentation, verification etc.

FDA COMPOUNDING QUALITY & OVERSIGHT

STERILITY · MATERIALS · REPORTING · POST-MARKET QUALITY

  • FD&C Act Section 501(a)(2)(A) · Insanitary Conditions

    Supports structured management of contamination risks

  • Section 503B · Bulk Drug Substance Controls

    Helps facilities maintain supplier, certificate-of-analysis, material qualification, specification, and traceability for bulk drug substances.

  • Section 503B · Registration & Drug Product Reporting

    Supports controlled collection, maintenance, and reporting of product information from outsourcing facilities that compound human drugs.

  • Section 503B · Adverse Event Reporting

    Supports electronic submission of all the serious and unexpected adverse drug experiences within 15days timeline.

PROOF & RESOURCES

Proven Results. Connected Quality

See how Qualityze QMS for Compounded Drugs helps strengthen quality, safety, and compliance controls in one connected ecosystem.

Data-Driven, Defensible Decisions

AI-powered insights grounded in your own data help make defensible decisions, faster.

Closed-Loop Quality Execution

One closed-loop system to manage reviews, approvals, investigations, and follow-up actions.

Giant Pharmaceutical Manufacturer logo

Giant Pharmaceutical Manufacturer

Life Sciences

Lower operational costs

Challenge

Manual investigations and email-based approvals delayed deviation closure across multiple manufacturing sites.

Result

Connected workflows improved ownership, accelerated reviews, and linked deviations directly with investigations, CAPA, and effectiveness checks.

Download the Case Study
Medical Device Manufacturer logo

Medical Device Manufacturer

ISO 13485 · FDA

Faster audit preparation

Challenge

Scattered documents and quality records made ISO 13485 and FDA inspection preparation time-consuming.

Result

Centralized records, controlled workflows, and traceable audit evidence helped teams maintain continuous inspection readiness.

Download the Case Study
Growing Biotechnology Company logo

Growing Biotechnology Company

Scaling operations

Lower quality process costs

Challenge

Rapid growth increased quality workloads, while manual processes struggled to scale across teams and programs.

Result

Configurable workflows standardized execution, improved visibility, and supported expansion without adding equivalent administrative overhead.

Download the Case Study

CUSTOMER SUCCESS STORIES

Compounded Drugs Leaders Trust Qualityze

From clinical-stage biotech to global pharma and medical device manufacturers, quality teams use Qualityze to cut review cycles, close findings faster, and stay continuously inspection-ready.

See Qualityze in Action

See how Qualityze connects operational processes and quality data to support better decisions and measurable improvement.

Qualityze
info@qualityze.com+1-877-207-8616

USA Corporate Headquarters

Qualityze Inc.3903 Northdale Blvd Suite: 100ETampa, FL 33624, USA

UK Regional Office

Qualityze Inc.450 Bath Rd, Longford, Heathrow,West Drayton UB7 0EB, United Kingdom

India Regional Office

Qualityze Solutions Pvt Ltd.No. 27, 1st floor, 80 Feet Ring Rd, 2nd Stage,KHB Colony, Basaveshwar Nagar, Bengaluru,Karnataka 560079, INDIAPhone: +91 96117 58187

2015 – 2026 Qualityze Inc