SIMPLE AND EFFECTIVE SOLUTIONS
We provide total solution for Quality System Management. We provide the tools and the knowledge base to ensure effective Quality System for your company. You have the flexibility to start with one of our simple products or go ahead with total roll out. Our products are designed for ISO Standards and 21 CFR Compliance. All our products are 21 CFR Part 11 Compliant.
CALIBRATION MANAGEMENT
Manage Calibration schedules and reports. Notifications and monitoring for past due calibrations. Create and assign work orders, track status of the work orders. Retain CAL and Maintenance records.
DOCUMENT CONTROL
Make only the current documents are available for the users. Review and approve the changes. Search and access the documents efficiently and effectively. Comply with ISO standards, FDA Regulations (21CFR part 820 for medical devices)
AUDIT MANAGEMENT
Easy planning of audits, simplified flow for execution of audits. Tracking and follow up for the audit plans. Audit reports, Non conformances are released automatically when the reports are approved. System provides reminders for Reviewers and Task Owners.
TRAINING RECORDS
Assignment of Training on as needed basis or automatically from the change control system. Training completion and documentation of training records . Compliance of the Training records with Regulations and Standards. System provides reminders for over due training items.
OUR COMMITTMENT
We understand each of our customer is unique. We provide customized solution to ensure 100 % customer satisfication.
User Friendly- Easy To Use
Our software solution includes simple and user friendly features. Easy to understand and easy do the trasactions.
Performance
We provide solutions that helps you meet the needs of your customer requirements and regulatory requirements.
Peace of Mind
•Unlimited Access • Simple 3 Tiered Pricing Options• No annual maintenance fees • No hardware to purchase • Secured and backup at Amazon AWS plattform.
Pay for what you use
• Purchase only the modules you need • Pay for additional training and support as needed.
Tell us what you want. We will take care of the rest.
We understand that the some of our customers do not have strong knowledge base regarding the standards and regulations. We provide online and offline trainings for our customers. We provide user friendly, simple and effective software solutions. The builtin work flow and features makes it easy to comply with regulations and standards. We also provide remote work load sharing, if you ever need any extra help. We do not claim to be 100% perfect. But that is our vision.
LATEST NEWS/BLOGS
Corrective and Preventative Action (CAPA)...
It is challenging to manually manage Corrective and Preventative Action…
What is Design Control of...
The Design Control of Medical Devices includes but not limited…
Medical Device Quality Risk Management
Risk Management in QMS and New Products Design (NPD) from…
QMS Software for ISO13485
There are many challenges involved when implementing a QMS system…
Top 5 issues with Document...
QMS Document change control is resource intensive, time consuming, prone…
Supplier Quality Management - How...
Effective Supplier Quality Management – How to do this? How…
TESTIMONIALS
"After implementation of Qualcy QMS, the recent customer audits have been easier to manage. It takes much less time to manage the QMS functions including CAPA, Audit, NCMR, Doument management and others. I am happy to recommend Qualcy QMS to other Bio-Med companies."
Margie Becker
Director of Quality, Phoenix Flow Systems
"Qualcy EQMS is a simple and easy to use web based application for managing QMS functions for small and medium size biotech companies."
Jack Diwu
Jack Diwu, Ph.D. President AAT Bioquest, Inc.
"Qualcy EQMS offers versatile and complete software solutions for managing QMS functions in the Biotech or Medical Device industry. The Qualcy EQMS application is simple to set up and use. It has user friendly features and automated work flow to manage the Document Control, CAPA, Audits, Training records, Equipment Calibration and Preventative Maintenance and others. I would recommend the use of Qualcy EQMS to automate the QMS functions."
Laura Freeman
Senior Quality Manager, Bioserv
OUR CUSTOMERS
Here is a sample list of companies who have believed in our products and services
