Qualcy Bio-Med CAL/PM Solutions
von Qualcy Systems5 / 5 6 Bewertungen
Wer nutzt diese Software?
QMS-Software für Biotech-, Medizingeräte- und andere regulierte Branchen.
Durchschnittliche Bewertung6 Bewertungen
- Gesamt 5 / 5
- Benutzerfreundlichkeit 4.7 / 5
- Kundenservice 4.7 / 5
- Funktionen 4.2 / 5
- Preis-Leistungs-Verhältnis 4.7 / 5
- Startpreis 99,00 $/Monat
- Kostenlose Version Ja
- Kostenlose Testversion Ja
Cloud, SaaS, Web
Installiert - Windows
Support während der Geschäftszeiten
Angaben zum Hersteller
- Qualcy Systems
- Gegründet 2014
Über Qualcy Bio-Med CAL/PM Solutions
* Qualcy Calibration Software unterstützt seit langem Biotech-, Medizingeräte- und Pharmaunternehmen bei der einfachen Verwaltung von Anlagen und Kalibrierungsdatensätzen entsprechend ISO- und FDA-Anforderungen.
* Entspricht den Anforderungen 21 CFR Teil 820, 21 CFR 210/211.
* Eingebaute Funktionen für elektronische Signaturen, Prüfnachweise und Konformität mit den Anforderungen von 21 CFR Teil 11.
Die Software verwaltet Aufzeichnungen zu vorbeugender Wartung (PM) und Toleranzüberschreitungen (OOT). CAL- und PM-Aufzeichnungen können automatisch geplant werden.
Qualcy Bio-Med CAL/PM Solutions Funktionen
- Benachrichtigung außerhalb der Toleranz
- Compliance Management
- Geräte Historie
- Management mehrerer Stationen
- Messwerte ablesen
- Statistische Daten-Berichterstattung
Die hilfreichsten Reviews für Qualcy Bio-Med CAL/PM Solutions
Bewertet am 27.8.2018
Robust Part 11 compliance
Kommentare: Robust compliance features for part11 compliance. Easy to use. Very good technical support.
Vorteile: 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.
Nachteile: 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.
Bewertet am 15.8.2018
Calibration PM software that best meets ours needs
Kommentare: Overall smooth on-boarding and transition. Training was very effective and helpful.
The Qualcy software is flexible and configurable. The supplier of this software provided IQ, OQ validation reports which saved us a lot of time. The software complies with 21 CFR Part11 requirements. It has been very helpful for audits and compliance requirements.
The software also provides option for managing PM and OOT records. This makes it easy to manage our equipment and our audit needs. Overall, satisfied with the product and account manager's support.
Nachteile: It was somewhat expensive compared to other products we looked at. After using the software for over a year, I think the software has paid back it's worth.
Bewertet am 22.8.2018
Flexible and user friendly
Kommentare: Overall very satisfied. It is a good program.
Vorteile: The Qualcy CAL/PM application is highly flexible. It was easy for us to change the labels, which made the user happy, as they could use the same wordings and terminologies for internal communications. Also, the application provides option for adding additional Approvers to the records on as needed besides the minimum required approval. Also provides attachment options to attach the external certificates and documents. The workflow is simple and easy. Very nice documentation for compliance purpose.
Nachteile: Expensive compared to other options we looked at. The cost included validation package, training support and data migration. I think it is well worth it.
Antwort des Softwareanbieters
von Qualcy Systems an 26.8.2018
Thanks for the positive feedback.
Bewertet am 13.6.2018
Very helpful, simple and easy to use
Vorteile: We had lot of existing equipment data that was migrated using an Excel upload option. It was very helpful. No manual data entry was required. It saved us lot of headache. This system is simple and easy to use. It is very easy to find the information when needed. It has been very helpful to manage the CAL, PM, OOT records for equipments that we use in the labs and manufacturing area. The reporting functionality provides quick view of the metrics for coming due records and overdue records. The reminders and notifications have been very helpful.
Nachteile: So far it has been very helpful. Not seen any issues. The system has lot of functionalities. We are planning to use the bar code labeling and scanning options.
Bewertet am 8.12.2018
Simple and easy to use Calibration management solution
Kommentare: Very easy to use software for asset tracking and calibration management. Good compliance features for audit trails and Part 11 compliance.
It was easy to set up the system. It is easy to use with nice and clean user interface.
The auto schedules for both calibration and PM have been very helpful. The reminders come to outlook inbox, makes it easy to track when something is coming due.
The support from Qualcy team was great. We got the complete validation packet. The training support was very good. Qualcy support people are friendly and nice to work with.
Nachteile: The options for preventative maintenance can be improved. The attachment option for checklists are there. Built in templates would be helpful. We use lot of spare parts, tracking options for spare parts would also be helpful.