GxP templates for pharmaceutical and medical device operations
Customizable biopharmaceutical and medical device templates designed to automate FDA regulated business processes replacing non-compliant spreadsheets or paper records.
Smartsheet templates for adverse events, product complaints, medical inquires, vendor management and change control.
Check out our feature-rich, cost effective solutions to bridge the gap between paper and expensive commercial applications. Use customizable and validated solutions that can be implemented in days. Templates are compliant with FDA regulations including 21 CFR Part 11.
Adverse Events
Capture, process, assess and submit Adverse Events. Generate MedWatch 3500a reports and PSURs.
Product Complaints
GMP Compliant solution for capturing Product Complaints in compliance with 21 CFR Part 211.198. Data entry forms, automated workflows, categorization, trending and reporting.
Medical Inquiries
Incoming calls from patients and/or healthcare providers could be potential AEs or Complaints. Our Medical Inquiries solution allows you to capture all of the pertinent call details to assess each case and escalate if necessary
Customizable biopharmaceutical and medical device templates designed to automate FDA regulated business processes replacing non-compliant spreadsheets or paper records.
Key Features
- Application Layer Security
- Uneditable audit trails
- Automated Workflows and Notifications
- Executive Dashboards and Reports
- Integrations
- Web-based data input forms
How to get it:
Submit a demo request form here.