Qualio is a cloud-based quality management solution for manufacturing businesses in a variety of industries. Key features include document creation and review, collaboration, employee training and audit trails.
Qualio enables users to create controlled documents and records as well as review and comment on documents in a collaborative environment. The system is able to create quality management documents such as policies, SOPs, work instructions, forms and other related content.
Users can set workflows for review and approval for documents and automated email notifications are sent to reviewers. Documents can be compared against previous versions, and the systems offers a real-time parallel approval process. Users can create training assessments with an unlimited number of multiple choice questions and see which content is waiting on review, approval or training to completed.
Lisa from SyntheticMR AB
Employees number: 11-50 employees
Better control of our documentation. Easy when the requirements from FDA is automatically handled.
Easy to make document updates and to send for review and approval.
It is a bit tricky to understand the management of NCRs . But I think it will be easier once you have used the system a bit more.
Rob from eHealth Technologies
Employees number: 201-500 employees
- ease of use! It's all right there, easy to find and easy to teach!
- compliance: we pull multiple reports from Qualio for our compliance audits and they are never questioned
- reporting: very thorough, detailed reports for training completion and distribution
- support listens to both feature requests and existing changes that are needed and addresses all promptly
- one feature that is missing is automatic reminders of incomplete assigned training (supposed to be on the roadmap, though!)
- most software will encounter an error now and then. While it is infrequent with Qualio, the error messages can be vague, prompting support calls that could be avoided with better detail.
Matt from Additive implants
User friendliness. The format and logical relationship between different categories of quality pages.
At first is a little confusing. I suggest making some tutorial videos for simple examples. For example how to create files and drafts and templates.
Retrieval of documents is easy, system is appropriate for a small company but also scalable as the company grows.
I've had no issues with the system. Some colleagues consider that more flexibility regarding usage is necessary.
Jonas from Cardiaccs
Employees number: 2-10 employees
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.
Easy to use with a very intuitive user interface, compliance with CFR 21 part 11, outstanding customer support, swift document navigation
Author change does not generate notification for new author which makes multiple authoring somewhat cumbersome. Currently lacks CAPA handling.
Strongly recommend this software for any company building a QMS from scratch or any company transitioning from paper-based to an online QMS.
Colin from eHealth Technologies
Employees number: 51-200 employees
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.
User interface, ease of use, ability to get staff to love using it.
This is so much easier than a paper system.
Christopher from Devine Guidance International, Inc.
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.
Peter from McElwee Pharmacies
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!
Brian from Rathmines Pharmacy
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.
Tara from Rowa Pharmaceuticals Ltd
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.
Trevor from Numera, Inc.
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.
Fionnuala from Molecular Medicine Ireland
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.
Paul from Arann Healthcare
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.