Home - Qualcy

AI BaseD Quality & Regulatory Intelligence Platform

BIOTECH & PHARMA
COMPANIES

Our expertise

We provide comprehensive regulatory compliance solutions enhanced with AI-powered regulatory change monitoring. From document control to FDA compliance – one unified platform for pharmaceutical quality and regulatory excellence. 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 RIM(Regulatory Intel Management) 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. Advanced machine learning algorithms monitor global regulatory landscapes and deliver actionable insights for pharmaceutical compliance teams.