GxP templates for Pharmaceutical, Biotech and Medical Device business processes

By Palm City Partners, LLC

Spreadsheets and manual GxP processes present data integrity risks due to a lack of audit trails. Let us convert your manual processes to automated workflows in Smartsheet. We have several Part 11 compliant templates available for a fixed price.

Clinical, Quality Assurance, Regulatory Affairs, Sales & Distribution

Our feature rich solutions bridge the gap between paper and expensive commercial applications for pennies on the dollar. Customizable and validatable solutions that can be implemented in days versus months. Compliant with FDA regulations including 21 CFR Part 11. Our GxP Smartsheet templates give you the features of commercial software for a fraction of the cost.
Deviations, Investigations, CAPAs and Change Control records can be created, processed and analyzed in a simple, Part 11 compliant database. Dashboards and reports can provide Quality Metrics.
Drafting, Collaboration, Review & Approval, Part 11 Compliant
Approved Vendor List. Electronic questionnaires, automated alerts
Study setup, enrollment tracking

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 at https://app.smartsheet.com/b/form/409e57ed97654b05863986d32d39cb7b