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Qualcy QMS
Description de Qualcy QMS
* Le logiciel de QMS (Quality Management System) de Qualcy Bio-Med a été conçu pour les entreprises biomédicales (notamment de biotechnologies, produits pharmaceutiques et dispositifs médicaux) afin de gérer les enregistrements QMS pour les exigences ISO13485 et FDA. * Le logiciel répond aux exigences de la norme 21 CFR Part 820. * Il possède des fonctionnalités intégrées de signature électronique et de pistes d'audit. Il est conforme aux exigences de la norme 21 CFR Part 11. Il simplifie la gestion des dossiers pour le contrôle des changements de documents, les plaintes, les audits, les CAPA (Corrective and Preventive Actions), NC Records, les dossiers de formation, etc.
Qui utilise Qualcy QMS ?
Ingénierie complexe, dispositifs médicaux, entreprises pharmaceutiques et biotechnologiques.
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Qualcy QMS
Alternatives à Qualcy QMS
Avis sur Qualcy QMS
Alternatives envisagées précédemment :
Best program out there
Commentaires : I am converting a completely paper based system for all internal and externals labs within my organization. This program will become a one-stop shop for all the compliance needs on these labs and will make everything effortless in creating and tracking records for all aspects of Quality.
Avantages :
The software is very intuitive. It is set up in the same fashion as a paper based system making the logic of the program very easy to follow.
Inconvénients :
The document management section of the software takes a long time to set up and get established. The outcome is very much worth the effort.
Réponse de l'équipe de Qualcy Systems
il y a 4 ans
Hi Kelly, Thanks for the favorable review. We are happy to know that we are able to meet your QMS and regulatory requirements.
Excellent product and Excellent support team
Commentaires : Sanjay was a huge help in getting us setup and modifying the modules to fit our organization. It is very easy to maintain once you get all your modules set up.
Avantages :
Support for this product to implement and do system changes to fit our organization was amazing. Weekly zoom calls helped a lot. Made implementing and maintain the system very easy.
Inconvénients :
With Document Management would have preferred the approval process be done with this instead of having to do a CCR.
Réponse de l'équipe de Qualcy Systems
il y a 3 ans
Hi Maraea, We appreciated your feedback. We have been continuously improving our product platform to exceed the expectation of our customers. In the recent release(2022-q1) we have rolled out the direct approval of documents in additions to the previous option through CR(change request work flow). Hope this will meet your needs. Thanks Qualcy Support Team
Qualcy eQMS
Commentaires : The software was easy to set up, easy to use, and the support is readily available when needed. We are working through a few issues, but no deal breakers and I would recommend this software to other medical device companies as long as the risk management is updated for compliance.
Avantages :
Document Control is easy to implement and easy to use. Very intuitive with a Draft Cabinet, Release Cabinet, Change Control etc.
Inconvénients :
We are working on the Risk Management to comply with 14971. Also templates took a little longer to learn and implement for requirements. More templates also need to be added for forms.
Réponse de l'équipe de Qualcy Systems
il y a 2 ans
Hello Carl, Thanks for your feedback. We have been working on continuously improving our solutions for compliance with latest changes in the regulations and standards. We have implemented the changes in the recent release (Q4.2022) to comply with ISO14971:2019. Hope that has resolved the issues and enabled the compliance requirements.
Robust Part 11 compliance
Commentaires : Robust compliance features for part11 compliance. Easy to use. Very good technical support.
Avantages :
The built-in E-Signature and Part11 compliance are very strong. Very easy to access the audit trails and change histories. This Qualcy CAL/PM Software is user friendly. The navigation is simple and intuitive. The technical support is top notch with strong knowledge base in Bio-Pharma areas. They provided the complete validation package that including IQ, OQ reports. The Qualcy support team helped us complete our PQ requirements, and helped us migrate the legacy data into the new application.
Inconvénients :
Initially the application set-ups and user registrations were challenging. It took us some time to learn the administrative features. The customer support was always available, ready to help.
Qualcy eQMS software
Commentaires : Qualcy EQMS has been help managing the day-to-day QMS functions. Saves lot of time. Has helped us reduce the errors.
Avantages :
Qualcy eQMS is easy to use with intuitive pages and builtin templates. Easy to search the records from the home page of the each modules. Also export option to Excel makes it life much simpler. Handling the audits have been much easier. The closed records are always in compliance status. No more stress out to find the records or show the records during the audits.
Inconvénients :
Initial implementation took longer than what we had expected. It was worth the effort. Qualcy Support team helped us move our existing data and documents to the new system. Qualcy provided full validation report for the software, this alone saved us months of efforts.
