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Isolocity

Isolocity’s quality compliance software holistically integrates over a decade of experience using quality principles from internationally recognized standards such as ISO 9001:2015, GMP, and more. It harnesses the power of automat...Read more about Isolocity

4.7 (30 reviews)

30 recommendations

QT9 QMS

QT9 Quality Management Software is a web-based QMS software used by companies to comply with ISO and FDA quality standards. The software is available for deployment either on-premise or in the cloud. The tool eliminates the need f...Read more about QT9 QMS

4.7 (74 reviews)

28 recommendations

REALTRAC

Realtrac is an on-premise job management solution designed for job shop manufacturers and modular machine shops. It helps small and midsize manufacturers to schedule workflows, manage shop operations, track inventories, manage pur...Read more about REALTRAC

4.1 (68 reviews)

22 recommendations

Intellect QMS

FrontRunners 2024

Intellect provides a flexible enterprise Quality Management Software (eQMS) solution and platform designed to meet any FDA and ISO compliance requirements, as well as digital transformation goals. Built on the Intellect Compliance...Read more about Intellect QMS

4.5 (80 reviews)

21 recommendations

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DELMIAworks

DELMIAworks (formerly IQMS) ERP is developed specifically for SMB and large discrete and batch process manufacturers in the aerospace, medical device, automotive, food and beverage, consumer products, plastics, packaging, and elec...Read more about DELMIAworks

4.1 (288 reviews)

20 recommendations

Unifize

Unifize takes a totally different approach to quality management operations. It is infinitely configurable to every quality process, meaning we map to your processes and not the other way around. Unifize brings people, processes a...Read more about Unifize

4.7 (11 reviews)

17 recommendations

Propel

Propel Software helps product companies grow revenue and increase business value with PLM, QMS, PIM, and supplier management on a single cloud platform. Our product value management solution connects commercial and product teams t...Read more about Propel

4.1 (16 reviews)

16 recommendations

Qualio

FrontRunners 2024

Qualio is a cloud-based quality management software system designed for quality-centric life science start-ups and scale-ups. Qualio empowers medical device, pharmaceutical, biotech and contract organizations to get to market fas...Read more about Qualio

4.5 (124 reviews)

14 recommendations

UniPoint Quality Management Software

uniPoint Quality Management Software is a modular on-premise quality management solution capable of integrating with other ERP systems. Built on Net Technology, a SQL database, and Crystal Reporting, this system is designed to gro...Read more about UniPoint Quality Management Software

4.0 (10 reviews)

10 recommendations

Total Lean Management (TLM) QMS Software

The Lean Machine is disrupting the market by making the best ideas from these client interactions available in an off-the-shelf landscape of 27 integrated modules for Quality, Risk, and Material Management at prices less than half...Read more about Total Lean Management (TLM) QMS Software

4.8 (36 reviews)

9 recommendations

FactoryLogix MES

FactoryLogix is a manufacturing solution suitable for businesses of all sizes. Key features include manufacturing execution, quality management, product lifecycle management, supply chain management, supplier management, asset man...Read more about FactoryLogix MES

4.8 (15 reviews)

6 recommendations

SafetyChain

FrontRunners 2024

SafetyChain's digital plant management platform gives process manufacturers the flexibility to rapidly address urgent challenges while offering scalability to expand and drive long-term value. • Gain visibility and control of qua...Read more about SafetyChain

4.6 (58 reviews)

5 recommendations

SafetyCulture

iAuditor by SafetyCulture is an inspection checklist application that allows users to build checklists, file reports and conduct inspections through a tablet or mobile phone. The solution is designed for a wide range of industries...Read more about SafetyCulture

4.5 (196 reviews)

4 recommendations

Exenta

Aptean Apparel Solution isn't just a solution; it's your strategic ally in the Fashion & Apparel industry. Designed to integrate every business aspect seamlessly, it transforms operations, offering real-time visibility and unparal...Read more about Exenta

3.4 (8 reviews)

4 recommendations

ACE Essentials

ACE Essentials is a turn-key fully validated quality management system. Designed for those companies wanting to move into an electronic QMS. Be fully compliant in 2 weeks with FDA, ISO, and other regulatory bodies....Read more about ACE Essentials

No reviews yet

4 recommendations

Cetec ERP

Cetec ERP is a manufacturing enterprise resource planning software built for small and medium sized businesses. Cetec ERP's cloud-based software is designed to help these companies efficiently manage all aspects of their manufactu...Read more about Cetec ERP

4.5 (43 reviews)

3 recommendations

Qualcy QMS

Qualcy eQMS application is simple and easy to use, designed for Bio-Med and Life Science industry requirements. This software helps maintain compliance readiness, and enables proactive problem solving with visual metrics and notif...Read more about Qualcy QMS

4.9 (17 reviews)

3 recommendations

TIPQA

TIPQA software modules provide a complete quality solution for businesses to improve their processes and produce high-quality products. TIPQA uses digital processes and a centralized database to ensure accuracy and consistency in ...Read more about TIPQA

3.8 (10 reviews)

3 recommendations

MasterControl Quality Excellence

FrontRunners 2024

MasterControl is the #1 QMS in the life sciences with more life sciences customers than any other QMS provider. For over 30 years, we’ve helped companies of all sizes bring their life-changing products to market sooner. We provide...Read more about MasterControl Quality Excellence

4.5 (422 reviews)

2 recommendations

1factory

1factory is a quality management solution suitable for manufacturing companies of all sizes. Cloud-based and on-premise deployments are available. The solution offers quality control plans, first article inspections, incoming insp...Read more about 1factory

5.0 (41 reviews)

2 recommendations

Buyers Guide

Last Updated: June 14, 2023

We wrote this guide to help you better understand what you need to consider when researching quality management software.

Here's what we'll cover:

What Is Quality Management Software?

Common Features of Quality Management Software

What Type of Buyer Are You?

Additional Capabilities to Consider

What Is Quality Management Software?

Quality management software (QMS) can help manufacturers measure (and therefore improve) the quality of their products and processes. This software category can refer to a broad range of applications that help manufacturers ensure quality across all supply chain activities—from design to production to distribution and eventually, service.

Some solutions on the market are created for general repetitive manufacturers, while others are designed for specialized manufacturing (e.g., pharmaceutical and biochemical manufacturers).

Common Features of Quality Management Software

The applications that can make up a quality management system aim to help manufacturers better control the four key components of quality management:

  • Quality planning;

  • Quality control;

  • Quality assurance and

  • Quality improvement.

Common functionality found in these systems includes:

Corrective and preventive action (CAPA)

Helps manage and track CAPAs by automatically routing corrective/preventive actions to the right quality manager so they can accept or reject the action. If accepted, the system will assign the action to a responsible party and start a workflow to investigate the root cause of the issue. Quality managers can attach documentation, assign priority to and monitor the status of each submitted action.

Audit management

Tracks all audit tasks and documents. Keeps a record of internal and third-party audits, tracks the scheduling and results of every audit and allows manufacturers to evaluate the effectiveness of auditors. An audit management application will usually be built to pass this information to the document control or CAPA modules so that audit information can be attached to the corresponding corrective/preventive action.

Complaint management

Helps manufacturers improve their quality of service by logging complaints from customers. Manufacturers can then investigate, respond to and resolve customer complaints. This application can provide manufacturers with useful feedback from end customers that might otherwise be difficult to obtain.

Change control

Identifies, defines and organizes the tasks required to implement a change in company processes or use of resources (e.g., packaging for a particular product). The system then analyzes how that change will impact the company.

Document control

Helps manufacturer’s organize all documents related to production—from the design files for a product to standards compliance documentation—in a centralized and searchable database. Documents can be easily sent to team members for review/approval and linked customer records, bills of materials (BOMs) and inventory.

Risk management

Enables manufacturers to more easily evaluate risk by standardizing risk assessment documentation and analyzing recurring issues in a single location. All risk files are associated with the corresponding document, project or process to improve analysis.

Statistical process control

Collects, analyzes and visually displays data from shop floor machines to measure statistical variations in output. Based on this data, manufacturers can fine-tune their production processes to reduce scrap rates, improve yield and produce a higher quality product.

Supplier quality management

Helps manufacturers qualify, select and monitor supply chain partners. Includes features for supplier scorecards, supplier qualification workflows and tracking of supplier issues such as non-conformances.

Employee training management

Helps manage employee training by tracking training activities and ensuring that relevant course materials are completed. Ensures compliance with requirement for proof of quality management training.

What Type of Buyer Are You?

Prior to evaluating a quality management program, you’ll want to know what type of buyer category you belong to:

Enterprise quality management software (EQMS) buyer. Manufacturers that require data integration across all applications should evaluate an integrated suite. These systems are able to manage quality compliance, track the source of quality issues, monitor shop floor operations and evaluate supplier relationships within a single system. EQMS systems can be integrated with other enterprise applications such as enterprise resource planning (ERP), supply chain management (SCM) and product lifecycle management (PLM) software to provide a more complete view of operational quality.

Single application buyer. Manufacturers that are not ready to purchase an enterprise system may consider a single solution to better manage one aspect of operations. Common applications that manufacturers can purchase on a stand alone basis include document control, change management and statistical process control (SPC) software.

Specialty buyer. Some manufacturers will have industry-specific requirements. For instance, pharmaceutical manufacturers require functionality to prove compliance with the Federal Drug Administration’s guidelines in Title 21 CFR Part 11. This means they need a system that helps properly track plant audits, control for drug quality and track all electronic documents according to FDA standards. Other manufacturers that should evaluate a specialized system include medical device, consumer products and electronics manufacturers.

Additional Capabilities to Consider

In addition to the key functionality we reviewed above, there are other capabilities that can be important to quality management, but aren’t present in every system. Here are a couple more to consider before implementing a new system.

Data visualizations. A QMS system collects high volumes of useful quality data. To synthesize all of this information and make analysis easier, manufacturers should consider the visual reporting capabilities of their system as a well-designed reporting dashboard will make it easier for the average user to make more data-driven decisions.

Example of a quality management reporting dashboard from IQMS

Web-based supplier portals. Many systems provide a Web-based portal to manage supplier relationships. These portals give suppliers real-time access to your supply requirements such as purchase orders, payment and invoicing as well as advance shipping notice (ASN) information. This makes it easier to interface with your suppliers and also gather valuable information about suppliers’ performance. Before implementing a supplier portal, it’s important to coordinate with suppliers to ensure you provide them with information they need to meet your inventory needs. Some manufacturers also share their supplier scorecard in this portal so suppliers understand the exact metrics you’ll use to evaluate their performance.