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Quality Management Software
Qualcy QMS reviews and summary
Qualcy Bio-Med QMS Software is a specialized Quality Management System engineered explicitly for the bio-medical sector, encompassing biotech, pharmaceuticals, and medical devices. It is pre-configured to manage QMS records in alignment with stringent regulations, primarily ISO 13485 and FDA requirements, including 21 CFR Part 820. The software includes built-in capabilities essential for compliance, such as electronic signatures (E-sign), comprehensive audit trails, and adherence to 21 CFR Part 11 for electronic records. It provides structured modules to manage critical quality processes including Document Change Control, Complaints, Audits, CAPA (Corrective and Preventi... Qualcy QMS is exclusively for bio-medical companies—such as medical device m...
Best for
Qualcy QMS is exclusively for bio-medical companies—such as medical device manufacturers, pharmaceutical firms, and biotech startups—that operate under strict FDA and ISO 13485 regulations. It is designed for Quality Assurance and Regulatory Affairs professionals who need a purpose-built system to ensure compliance and streamline quality processes from the outset.
Starting price
$99.00 Per-Month
Category
Quality Management Software
Vendor
Qualcy Systems
Key takeaways
Our verdict
Qualcy QMS is a focused and compliant solution that delivers precisely what regulated bio-medical companies require. Its out-of-the-box configuration for key standards makes it a efficient choice for ensuring quality system integrity and simplifying the path to regulatory approval and maintenance.
Quick facts
Qualcy QMS at a glance
Overall rating
5/5
Reviews
11
Starting price
$99.00 Per-Month
Vendor
Qualcy Systems
Founded
2014
Location
United States
Category
Quality Management Software
Ratings
Qualcy QMS ratings
Ratings in this section summarize available rating data. Software reviews are shown separately when users submit reviews.
Decision notes
Qualcy QMS pros and cons
Potential strengths
- Clear buyer-fit positioning is available in the profile data.
- Starting price is available in the profile data.
Points to verify
- Confirm current pricing, contract terms, and included plan details with the vendor.
- Confirm product-specific availability for category-level features before buying.
- There are no written reviews for this software yet.
Buyer fit
Who uses Qualcy QMS?
Qualcy QMS is exclusively for bio-medical companies—such as medical device manufacturers, pharmaceutical firms, and biotech startups—that operate under strict FDA and ISO 13485 regulations. It is designed for Quality Assurance and Regulatory Affairs professionals who need a purpose-built system to ensure compliance and streamline quality processes from the outset.
Feature research
Qualcy QMS features
These are common features buyers compare in Quality Management Software. Product-specific availability should be confirmed with the vendor.
Compliance Audit Oversight
Organize and perform audits to ensure compliance with legal and internal standards.
Grievance Management
Track and resolve customer grievances and feedback to enhance service quality and retention.
Compliance Monitoring
Monitor and address policy non-compliance across services, products, or supplier activities.
CAPA Management
Analyze root causes of errors and implement measures to prevent their return.
Product Defect Tracking
Systematic tracking of reported defects (errors) in products or services to facilitate the release of new, corrected versions.
Document Control & Coding
Oversees the creation, approval, and distribution of documents and processes to maintain compliance with industry standards.
Equipment Maintenance & Management
Track and maintain production equipment while reallocating assets based on deployment needs.
ISO Compliance Tracking
Monitor workflows and production to ensure full compliance with international ISO quality standards.
Maintenance Planning
Evaluate and schedule maintenance tasks and upgrades to extend the lifespan of physical infrastructure.
Risk Assessment & Mitigation
Detect, assess, and develop strategies to minimize organizational risks.
Supply Chain Quality Control
Qualifies, selects, and continuously monitors partners within the supply chain to ensure quality.
Learning Progress Tracking
Monitor the advancement of employees or students as they move through structured learning curricula.
Pricing
Qualcy QMS pricing
Starting price
$99.00 Per-Month
Visit Website
Pricing model: Per User
Pricing can change. Confirm current plans and terms with the vendor.
Compare
Qualcy QMS alternatives
Compare Qualcy QMS with other Quality Management Software tools that buyers often evaluate.
Genius ERP by Genius Solutions
Genius ERP is purpose-built for custom manufacturers who do make-to-order or engineer-to-order work. It manages the entire quote-to-cash cycle—estimating, engineering, production s...
Benchmark ESG | Gensuite by Benchmark ESG | Gensuite
Benchmark ESG | Gensuite Quality Management Software is a powerful platform designed to help organizations meet and exceed quality standards and customer expectations. It provides...
Greenlight Guru by Greenlight Guru
Greenlight Guru is a purpose-built electronic Quality Management System (eQMS) exclusively for the medical device industry. Developed by seasoned medical device professionals, it i...
REALTRAC by Realtrac Holdings
REALTRAC is a specialized shop management system developed by Realtrac Holdings, focusing exclusively on the manufacturing software needs of machine shops, job shops, and make-to-o...
QT9 QMS by QT9 Software
QT9 QMS is an all-in-one, web-based Quality Management Suite designed to digitally transform quality processes for modern organizations. It provides a unified platform to automate...
Qualtrax by Qualtrax
Qualtrax is a complete quality and compliance software system designed for heavily regulated industries. It serves as a central hub to manage and control documentation, automate co...
Intellect by Intellect
Intellect offers a modern, no-code Quality Management System (QMS) software platform designed to enhance quality operations and significantly reduce associated costs—claiming up to...
Software reviews
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FAQ
Qualcy QMS FAQs
Qualcy Bio-Med QMS Software is a specialized Quality Management System engineered explicitly for the bio-medical sector, encompassing biotech, pharmaceuticals, and medical devices. It is pre-configured to manage QMS records in alignment with stringent regulations, primarily ISO 13485 and FDA requirements, including 21 CFR Part 820. The software includes built-in capabilities essential for compliance, such as electronic signatures (E-sign), comprehensive audit trails, and adherence to 21 CFR Part 11 for electronic records. It provides structured modules to manage critical quality processes including Document Change Control, Complaints, Audits, CAPA (Corrective and Preventi...
Qualcy QMS is exclusively for bio-medical companies—such as medical device manufacturers, pharmaceutical firms, and biotech startups—that operate under strict FDA and ISO 13485 regulations. It is designed for Quality Assurance and Regulatory Affairs professionals who need a purpose-built system to ensure compliance and streamline quality processes from the outset.
Qualcy QMS pricing is listed from $99.00 Per-Month. Pricing can change. Confirm current plans and terms with the vendor.
Qualcy QMS is listed in Quality Management Software.
Qualcy QMS is listed with Qualcy Systems as the vendor.
Buyers often compare Qualcy QMS with other Quality Management Software tools such as MasterControl Quality Excellence, Genius ERP, Benchmark ESG | Gensuite, Greenlight Guru. Review ratings, pricing, and fit before choosing.
Yes. Use the Write a review button on this page to submit a software review for Qualcy QMS.
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