QMS software for small businesses
I work for a small manufacturing company (less than 50) and I am looking for a reasonably priced software that will help us manage our quality workflows, documents and records.  Any recommendations, comments or even warnings are welcomed.  One that we are taking a closer look at is called Unipoint.  If anyone has experience with this software, your feedback would be very helpful. 
3 Replies
Samantha, this is what I got today from a company  www.etq.com

EnGage Plus!
Automotive, aerospace and defense, consumer products, food and beverage, medical device, industrial, pharmaceutical, wind power
AssurX Cloud QMS and on-premises QMS
Energy and utilities, life sciences, manufacturing, high tech, food and beverage
Automotive, plastics, metalworking, medical technology, aerospace, electronics, chemicals and pharmaceutical, consumer goods, laboratories, food industry
ComplianceQuest EQMS Suite
Manufacturing, life sciences, cannabis, consumer packaged goods, food and beverage
 Cority (formerly Medgate)
Cority Quality Management Software, IQS Trubox
Aerospace and defense, chemicals, government, mining and metals, life sciences, automotive, manufacturing, food and beverage, oil and gas, construction, energy and utilities
 Dassault Systèmes
Life sciences
Ennov QMS
Life sciences
ETQ Reliance
General discrete manufacturing, life sciences, medical devices, electronics, food and beverage, chemicals, consumer packaged goods, aerospace, automotive, aviation, oil and gas, furniture
Aerospace and defense, aviation, energy, food and beverage, healthcare, life sciences, manufacturing
Intelex Quality Management Software
General discrete manufacturing, semiconductor, miscellaneous others
 IQVIA (formerly Pilgrim Quality Solutions)
Pharmaceutical, biotech, medical device, blood and tissue
MasterControl Quality Excellence
Life sciences and other regulated industries
 Omnex Systems
Enterprise-wide Quality and Integrated Management System (EwQIMS)
Automotive, aerospace, semiconductor/electronics, medical device
Oracle Quality Management Cloud
Various industries
 Plex Systems
Plex Manufacturing Cloud (Quality Management)
Aerospace, automotive, food and beverage, electronics, general manufacturing, metalworking, metalforming
Windchill Quality Solutions
Aerospace and defense, automotive, healthcare, manufacturing, oil and gas, industrial, consumer products
QAD CEBOS EQMS (Enterprise Quality Management System)
Automotive, general manufacturing, life sciences, food and beverage
RizePoint Quality Management Platform
Retail consumer goods, food/beverage and hospitality, food processing and distribution, consumer goods manufacturing
SAP Quality Management (QM)
Various industries
Siemens Opcenter Quality (formerly known as QMS Professional)
Automotive, general discrete manufacturing
 Sparta Systems
Sparta TrackWise and TrackWise Digital
Life sciences, food and beverage, consumer products, chemicals
 TIP Technologies
TIPQA Quality Management Solution
Aerospace and defense, complex manufacturing
Vault Quality Management System
Life sciences

Hope you can do the search and find the right one. 


Mingzhi Deng, major
Even though you are small, don't short the user requirements. A lot of QMS providers offer solid out-of-the-box solutions these days, and you'll need those user requirements to truly evaluate them.

Some things to consider:
  1. Cloud vs local. Advantages are in both. If going for cloud (and for a small company this might be really advantageous) pay attention to the change approach.
  2. Audit trail. Can't stress how useful a human readable audit trail is that captures all change meta data
  3. Data governance. How will important data components such as product data be governed. 
  4. Interfaces. Do you need to interface with an ERP? Some other system?
  5. Training support. Some of the out-of-box solutions offer standard procedures and training. Make sure to evaluate that as part of your review.
Sorry the list is a little hodgepodge. I work in pharma, and then mostly larger companies, so my approach is colored by my experiences and I am trying to draw from that.
Hi Samantha.

Is your company in a regulated industry? IMHO, that makes a big difference on your QMS software partner. While solutions for regulated industries may cost more, they are necessary for compliance to some obscure regulations (like FDA 21 CFR 11 for life science companies). Establishing a partnership with a vendor who themselves has a robust QMS and who understands the needs of your business is an investment you will not regret, especially if you opt for a cloud-based solution.

To Jeremiah's point, it's critical that you get the business requirements correct. I recommend half the project schedule be spent on requirements (but I've only got 20 years in regulated computer systems validation, so what do I know? ;) ). Spend time doing process flows for your current process and optimizing it so you don't waste time and money implementing broken processes. Write a meaningful business requirements document that can be provided as part of the RFQ process. The better your business requirements presented to potential vendors, the better you and the vendor can evaluate fit, cost and schedule. Don't forget about data privacy regulations like GDPR, especially for your customer master data. If you find a product (and vendor) you like, look at the out-of-the-box workflows and processes and determine if you can adapt to use them as-is without significant configuration or any customization. The closer your processes match the strength of the tool you use, the more comprehensively and robustly the application will serve your business needs. The more rigid you are about cramming a square application into the round hole of your existing process, the more you will fight the software instead of benefit from it.

Treat IT vendors (especially cloud vendors) just as you would any other supplier: do the risk analysis and manage them on your ASL. Have contracts / MSAs / Quality Agreements / whatever else you need to establish contratual obligations for service calls, uptime, data breach recovery, patch management, and even system performance if necessary. Write SCARs when your IT vendors do not meet their contracts. Conduct on-site audits or insist on evidence they are compliant with their QMS (via ISO certification or 3rd party audits).

Finally, while I may get shot for this, some things actually can be adequately handled with tools like Sharepoint 2016 / 365. For small businesses with simple workflows, current versions of Sharepoint are very useful. Depending on your industry, you may need to ensure you have a robust validation for a Sharepoint solution and an effective change management system in place, but don't dismiss the idea entirely. I've seen medium-sized medical device companies use Sharepoint very effectively for CAPA, internal audits, supplier audits, and even complaint handling.

As for specifics, I've worked with systems from a number of the companies Mingzhi listed. Your success will hinge more on your implementation partner (not always the same as the company who makes the software) and your hosting partner (if using a cloud-based solution) more that the software application company itself. In the medical device space, I struggled with Intelex because their QMS allowed them to be more flexible than I was comfortable with. My experience with Veeva was they are committed to a structured QMS and I could trust they would do the right thing. SAP is an industry god, but there are no inexpensive SAP solutions. Sparta (TrackWise) and EtQ are both comprehensive, but also expensive (Sparta a little more expensive than EtQ).

As in all things, your mileage may vary.