Qualityze

QUALITY MANAGEMENT FOR REGULATED INDUSTRIES

Quality Management Software for Plastic and Rubber Industry

Bring quality, production, supplier, and compliance activities into one connected Salesforce ecosystem. Qualityze gives plastic and rubber manufacturers a common system for controlling materials, monitoring processes, resolving defects, and maintaining traceable quality records across plants and production lines.

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

Trusted by quality teams across regulated industries

Read their success stories

INDUSTRY-SPECIFIC CHALLENGES

Plastic and Rubber Quality Challenges, Solved

Qualityze enables manufacturers to handle material variation, process defects, problems with suppliers, customer requirements, and corrective actions by gathering the appropriate quality information together.

The challenge

Resins, polymers, rubber compounds, additives, fillers, and the other materials can differ from one batch to another or depending on the supplier. A slight alteration in the properties of the material may have an effect on the dimensions, strength, appearance, durability, or on the performance of the finished product.

How Qualityze solves it

Qualityze links together information about material specifications, supplier records, incoming inspections, quality problems, and the corrective actions taken. It enables teams to identify the origin of a material-related issue and to track the response until the problem is closed.

SYSTEM CAPABILITIES

How Qualityze Keeps Manufacturing Quality Connected?

Qualityze incorporates production, materials, suppliers, equipment, and quality records into a single system so that teams can obtain a clearer understanding of what is going on the floor and what needs to be addressed.

Connected, Closed-Loop Platform

Combine the inspections, production records, supplier activities, risks, investigations, audits, training, and corrective actions into a single quality environment.

IdentifyTriageAssessInvestigateActVerifyLearn

The system ensures end-to-end traceability so that informed decisions can be made.

Connected Biotech quality and supplier operations
Connected Biotech quality and supplier operations

Plastic and Rubber Quality Management System

Link inspections, nonconformances, production problems, investigations, corrective actions, and follow-up activities together so that quality issues can be directed towards resolution.

Connected Biotech quality and supplier operations

Product Data Management System

Keep product specifications, material requirements, validation information, engineering records, and change information connected when products or processes change.

Connected Biotech quality and supplier operations

Asset Management System

Keep records of track calibration, qualification, maintenance, servicing, and the equipment status for all production equipment such as that used in molding, extrusion, mixing, testing, and other similar processes.

Connected Biotech quality and supplier operations

Environmental, Health and Safety System

Combine the workplace incidents, permits, exposure records, and risk controls to achieve safer operations in manufacturing facilities.

Supplier Relationship Management System

Link supplier qualifications, quality agreements, performance, SCARs, and corrective actions. This gives quality teams a full supplier record.

QualifyApproveReceiveMonitorChangeCorrect
Connected Biotech quality and supplier operations

Customer Quality Management System

Connect customer complaints, product issues, investigations, and corrective actions to identify recurring concerns and address product quality risks.

CaptureAssessInvestigateActTrendImprove
Connected Biotech quality and supplier operations

Built-In Continuous Improvement Tools

Use the 5 Whys technique, carry out a risk assessment, conduct a root cause analysis, perform effectiveness checks, and refer to the relevant quality records in order to deal with recurring defects and enhance process performance.

DetectAnalyzePrioritizeCorrectVerifyStandardize
Connected Biotech quality and supplier operations

7

Quality, safety, product, asset, supplier, customer, 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 Defect Detection to Process Control

See how Qualityze assists manufacturers in getting their quality activities out of disconnected systems and into connected workflows.

Manual and disconnected Plastic and Rubber quality operations

MANUAL · DISCONNECTED · REACTIVE

Material, production, supplier, and quality records sit across separate systems
Defects, supplier issues, and customer complaints follow different paths
Process changes require teams to chase documents and approvals
Manual approvals slow quality decisions and corrective actions
Leadership has limited visibility into recurring defects and supplier risks
Controlled and proactive Plastic and Rubber quality operations

VALIDATED · CONNECTED · INSPECTION-READY

One Salesforce-native platform brings quality records and workflows together
Structured workflows connect intake, investigation, action, and follow-up
Change workflows connect approvals with affected documents and training
Compliant e-signatures support controlled approval workflows
Enterprise dashboards provide visibility into quality performance and risk controls

Regulatory Frameworks Qualityze Supports

Quality, Safety & Material Standards

  • ISO 9001 – Quality Management Systems

  • ISO 14001 – Environmental Management Systems

  • ISO 45001 – Occupational Health & Safety

  • ISO 13485 – Medical Device Quality Management

  • ISO 14971 – Medical Device Risk Management

  • ISO 11469 – Plastic Product Identification & Marking

  • ISO 1043 – Basic Polymer Identification

  • ISO 177 – Plasticizer Migration Testing

  • ISO 868 – Plastics & Rubber Hardness Testing

Testing, Regulatory & Industry Requirements

  • ASTM D638 – Tensile Properties of Plastics

  • ASTM D790 – Flexural Properties of Plastics

  • ASTM D2240 – Rubber & Plastic Durometer Hardness

  • ASTM D412 – Vulcanized Rubber Tensile Properties

  • ASTM D395 – Rubber Compression Set

  • ASTM D471 – Rubber Property: Effect of Liquids

  • FDA 21 CFR Part 177 – Indirect Food Additives: Polymers

  • FDA 21 CFR Parts 210 & 211 – Pharmaceutical cGMP

  • IATF 16949 – Automotive Quality Management

  • AIAG Core Tools – APQP, PPAP, FMEA, MSA & SPC

Environmental, Chemical & Packaging Requirements

  • REACH Regulation (EC) No. 1907/2006 – Chemical Registration & Restrictions

  • RoHS Directive 2011/65/EU – Restriction of Hazardous Substances

  • CLP Regulation (EC) No. 1272/2008 – Classification, Labeling & Packaging of Chemicals

  • Packaging & Packaging Waste Regulation (EU) 2025/40 – Packaging Requirements

  • Regulation (EU) No. 10/2011 – Plastic Materials Intended for Food Contact

  • California Proposition 65 – Chemicals & Consumer Product Exposure

  • GxP Guidelines – Quality Requirements for Regulated Manufacturing

PROOF & RESOURCES

Proven Results. Connected Quality

Observe how manufacturing organizations make use of Qualityze to enhance their quality, supplier, and compliance controls via a single interconnected ecosystem.

Data-Driven, Defensible Decisions

AI-powered insights, based on your own data, enable teams to make decisions more quickly and provide them with clear evidence.

Closed-Loop Quality Execution

A single system that can be used for managing reviews, approvals, investigations, corrective actions, and follow-up activities.

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

Plastic & Rubber 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 links the daily quality work with the information that the teams need to make better decisions and to improve manufacturing performance.

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