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About Qualcy QMS

Qualcy QMS is a quality management system software from Qualcy Systems designed for life sciences companies. It provides document control, training management, and audit management so organizations can maintain compliance with industry regulations. The software helps users track and manage quality processes efficiently while ensuring adherence to established standards. Qualcy QMS supports customizable workflows, real-time reporting, and integrates with existing systems to facilitate information flow. Its user-friendly interface allows for easy navigation and user adoption. Key capabilities: document management training tracking audit management compliance tracking real-time reporting Best for: life sciences organizations that need to manage and maintain quality standards and regulatory compliance efficiently.

Qualcy QMS Details

Vendor
Qualcy Systems
Year Launched
2014
Location
Qualcy Systems Inc 5755 Oberlin Dr, San Diego, California 92121, USA
Deployment
cloud, on premise, windows, linux
Training Options
documentation, videos, live online, in person
Countries Served
All Countries
Languages
English
Users
Small to large enterprises in regulated industries, Quality managers, Compliance officers
Industries Served
Biotech, Medical Devices, Pharmaceuticals, Manufacturing
Tags
Quality Management, Compliance, ISO Standards, FDA Regulations, Document Control, Audit Management

Qualcy QMS's In-App Market Place

Does Qualcy QMS have an in-app market place?

Yes

How many Mini-Apps in the marketplace?

1

Mini Apps

N/A

Pricing Options

Free trial
Free version
Request a quote
Promo Offer

Accepted Payment Currencies

USD ($), EUR (€), GBP (£), AUD (A$), CAD (C$), JPY (¥), CHF (Fr), INR (₹), CNY (¥)

Pros & Cons

  • Ease of use: The software is intuitive and user-friendly, making it easy to navigate and use.
  • Customer support: The customer support team is highly responsive and helpful, providing timely assistance and guidance.
  • Robust features: Qualcy QMS offers a comprehensive range of features to manage various aspects of quality management, including document control, change control, CAPA, and training.
  • Compliance: The software is designed to meet regulatory requirements, such as ISO 13485 and FDA 21 CFR Part 820 and 11.
  • Part 11 compliance: Strong built-in features for electronic signatures and audit trails to ensure compliance with 21 CFR Part 11.
  • Validation support: Qualcy provides comprehensive validation packages, including IQ, OQ, and PQ reports, to streamline the validation process.
  • Data migration assistance: The support team helps with migrating existing data and documents to the new system.
  • Initial setup time: The initial setup and configuration can be time-consuming, especially for larger organizations.
  • Risk management: Some users have reported that the risk management module requires additional development to fully comply with ISO 14971.
  • Document management: The document management section can be challenging to set up and establish, but the outcome is worth the effort.
  • Limited template options: More templates may be needed for specific forms and requirements.

Qualcy QMS's Support Options

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