Quality Management Software

5 / 5 9 reviews

Who Uses This Software?

Quality & Compliance leaders in Life Sciences (biotech, medical devices, therapeutics, CxOs) striving for seamless compliance with FDA, ISO, GxP requirements.


Average Ratings

9 Reviews
  • 5 / 5
    Overall
  • 5 / 5
    Ease of Use
  • 5 / 5
    Customer Service

Product Details

  • Free Demo
  • Deployment
    Cloud, SaaS, Web
  • Training
    Documentation
    Webinars
    Live Online
    In Person
  • Support
    Online
    Business Hours
    24/7 (Live Rep)

Vendor Details

  • Qualio
  • www.qualio.com/
  • Founded 2010
  • United States

About Quality Management Software

Life Sciences Quality Management. Simplified. Qualio is the all-in-one quality management platform that helps you bring products to market faster and achieve 100% FDA/ISO/GxP compliance in audits. Trusted by quality teams all over the world to automate critical compliance workflows like Document Control, Training, NCRs, CAPAs, Audits, Suppliers, Complaints and more. Talk with us today!


Quality Management Software Features

  • Audit Management
  • Compliance Management
  • Corrective Actions (CAPA)
  • Defect Tracking
  • Document Management
  • Feedback Tracking
  • Incident Management
  • ISO Standards Management
  • Knowledge Management
  • Maintenance Management
  • Nonconformance Tracking
  • Risk Management
  • Supplier Quality Control
  • Testing Management
  • Training Management

Quality Management Software Reviews

Perfect for Medical Device startups

Aug 10, 2016
5/5
Overall
5 / 5
Ease of Use
4 / 5
Features & Functionality
5 / 5
Customer Support
4 / 5
Value for Money
Likelihood to Recommend: 9.0/10 Not
Likely
Extremely
Likely

Pros: Easy to use with a very intuitive user interface, compliance with CFR 21 part 11, outstanding customer support, swift document navigation

Cons: Author change does not generate notification for new author which makes multiple authoring somewhat cumbersome. Currently lacks CAPA handling.

Overall: Without Qualio we would not have been able to achieve our critical milestone of ISO 13485 certification before the end of 2015. We are now prepared to take the next steps towards compliance with European regulatory requirements and the CE mark.

Recommendations to other buyers: Strongly recommend this software for any company building a QMS from scratch or any company transitioning from paper-based to an online QMS.

A quick path to SOC II type II

Aug 09, 2016
5/5
Overall
5 / 5
Ease of Use
5 / 5
Features & Functionality
5 / 5
Customer Support
5 / 5
Value for Money
Likelihood to Recommend: 10.0/10 Not
Likely
Extremely
Likely

Pros: User interface, ease of use, ability to get staff to love using it.

Cons: Nothing.

Overall: With Qualio we were able to get SOC 2 Type II certified in about a year and a half, which is very impressive. This has lead to increased trust with our customers and helps us grow our business faster.

Recommendations to other buyers: This is so much easier than a paper system.

QMS Software That is Actually Easy to Use

Feb 28, 2016
5/5
Overall
5 / 5
Ease of Use
5 / 5
Customer Support

Comments: There are so many options available when it comes to software tools to assist in the managing of an effective Quality Management System (QMS). The Qualio product is easy to deploy and has the functionality needed to support a regulated industry such as the Med-Tech.

Great at helping us keep on top of SOPs and training. In short, it's great!

Nov 20, 2014
5/5
Overall
5 / 5
Ease of Use
5 / 5
Customer Support

Comments: In the pharmacy sector, the Pharmacy Act and regulations had placed a responsibility on our business to provide "Standard Operating Procedures" (SOPs) that attempt to describe in great detail how activities and tasks are performed. This has meant the creation of hundreds of SOPs.

Managing these SOPs can be difficult and much of the material goes out of date quickly, requiring re-print, re-acknowledgement and endless reams of paper hanging around our dispensaries. In order to eliminate this problem I was very interested to hear what the team at Qualio had to say. And I was hooked.

Taking advantage of advances in technology to improve SOP management, by developing and delivering online SOPs has meant we have a seamless notification directly by email to all our staff. SOPs can be easily updated and changed on-line, and appointed senior staff can contribute and negotiate on detail. Our staff found it to be novel and enjoy using it - and the facility to distribute a few at a time means it is manageable for all individuals.

In short, it's great!

We will have no problems passing inspections by the regulator thanks to Qualio

Nov 20, 2014
5/5
Overall
5 / 5
Ease of Use
5 / 5
Customer Support

Comments: Qualio has been invaluable in helping our business comply with industry regulations. It has replaced our paper system which we found very cumbersome and hard to maintain across multiple stores. Now, all our workflows are automated, we have excellent visibility over our compliance status and the recording of compliance information such as electronic signatures makes us sure that we will have no problems passing inspections by the regulator in the future.

Qualio has forever-changed how we manage document control

Nov 20, 2014
5/5
Overall
5 / 5
Ease of Use
5 / 5
Customer Support

Comments: Coming from a manual paper based system, it's amazing how it all just works. It is extremely easy to compare different versions of documents during review and approval. Qualio has forever-changed how we manage document control.

Love the easy to use interface and the timely notifications

Nov 20, 2014
5/5
Overall
5 / 5
Ease of Use
5 / 5
Customer Support

Comments: Qualio allows me to quickly and efficiently manage my QMS procedures and training. My employees love the easy to use interface and the timely notifications, and I enjoy the ability to track changes and quickly view the status of each procedure.

Intuitive software for managing quality and compliance

Aug 09, 2014
5/5
Overall
5 / 5
Ease of Use
5 / 5
Customer Support

Comments: Qualio is an intuitive quality management platform that will lower costs for companies through streamlining time consuming workflows. It is a very exciting system and I've recommended it to a number of companies and consultants.

Recommended for small companies implementing a quality management system for the first time

Aug 09, 2014
5/5
Overall
5 / 5
Ease of Use
5 / 5
Customer Support

Comments: I would recommend ZenDoc to small companies implementing a quality system for the first time to seriously consider using ZenDoc as a way to reduce workload and paper trail in a cost effective and easy manner that is flexible to grow with the company.