Our expertise
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.
Regulatory Intelligence (RI) Management
Qualcy eQMS provides simple interface for managing AI (artificial intelligence) based Regulatory Intelligence for Pharma & Biotech Companies. Stay Ahead of Regulatory Change and Take Proactive Actions
Risk Management
Qualcy eQMS provides simple interface for managing Risk Management process that complies with ISO14971:2019 and other regulatory bodies (FDA, EU MDR, Health Canada).
Design Control Management
Qualcy eQMS provides simple interface for managing design control process for medical device applications. This includes, Qualcy eQMS provides simple interface for managing design control process for medical device applications
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 commitment
We understand each of our customer is unique. We provide customized solution to ensure 100 % customer satisfication.
99%
User Friendly- Easy To Use
Our software solution includes simple and user friendly features. Easy to understand and easy do the trasactions.
96%
Performance
We provide solutions that helps you meet the needs of your customer requirements and regulatory requirements.
98%
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.
95%
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.
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Testimonials
What clients say about our work
“They were responsive, knowledgeable, and genuinely dedicated to addressing our inquiries. What truly impressed me was their willingness to tailor their assistance according to our unique needs.“
"Since we started using the eQMS from Qualcy Systems, we have been able to reduce the number of customer complaints and audit findings by more than 60% in the last 1 year. It has been easy for us manage the customer complaints, Internal audits. With Qualcy EQMS, it is easy for us to manage training process for our employees. All our employees are trained and approved, before they start the production. We have been able to track the training compliance and number of process errors. We are always up-to-date on the documents and records. I would definitely recommend use of Qualcy EQMS systems."
"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."
"The management of Quality System was overwhelming for small company like us. The Qualcy System has been very useful for us. We are more focused on our core areas of Research and Development of new products. The documentation of processes is taken care of by the Qualcy System eQMS. We no longer worry so much about the compliance requirements. It is easy to use and the system is intuitive. Not much training needed. I am happy to recommend Qualcy EQMS."
“The training support was very good. Qualcy support people are friendly and nice to work with.“
“Qualcy provides a great platform for our start up company to build our Quality System in a step by step, easy to use format. The support for implementation was timely and thorough.“
“high powered and customizable eQMS for a very reasonable price”
“Excellent product and Excellent support team”
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