Quality management, document control, & training
5/5 (4 opiniones)Puntos a favor
The ease of use is second to none. I have a lot of users who need access to the system who themselves have never worked in a Quality Management System before, let alone in the Pharma industry before. If I had to give them access to other systems (like Master Control, Trackwise, Documentum) I'd be extremely worried about their ability to utilize the system in an efficient manner. QualityOne makes every task (like approving docs, adding a CAPA, etc) simple. To date, I have not had one user ever report the system was hard to use. Many users have already become super users just by using the system on a day by day basis.
Puntos en contra
The initial configurations sometimes do not push through correctly to the production system, and these arent checked before go-live. But these issues are easily remediated and typically, in our case, have not caused any downtime.
We use QualityOne as an electronic quality management systems.
Puntos a favor
Best in class document and record management and pretty good quality event management to boot. UI is great, document handling is above par, and while quality events can sometimes feel like an add on, the UI is still great and customization / configuration is a breeze. Additional selling points for us were the full API and excellent and responsive troubleshooting / support.
Puntos en contra
Quality event management utilizes a slightly different format than document management, and it's not as robust as the document management, but the value is still excellent and configuration options allow more flexibility than other solutions we've seen in the price range.
We have increased quality compliance with our documentation while eliminating over 2 peoples worth of effort across our site. We have been able to move from several document management solutions to 1 because it is meeting all of our needs.
Puntos a favor
Easy to navigate and understand user interface. Users at my site are consistently able to use the product with zero formal training.
Puntos en contra
Currently difficult to print documents, many steps are required.
We were looking for a solution that did not require a lot of IT time once the product was up and running as well as giving our suppliers access to their quality data. QualityOne will accomplish both.
Puntos a favor
The ability to configure the software is great and the main reason we selected QualityOne to replace our internally build software. The Veeva team has been exceptional in working to understand our processes and guiding us on how to best translate it into QualityOne. The software is definitely working for us vs. us working for the software.
Puntos en contra
Sometimes the relationships between objects is not automatically created. For example you can relate a finding to an audit, but then you must go into the audit and relate it back to the finding. It should make that relationship both ways automatically.