Overview

FDA scrutiny regarding regulatory compliance has also grown significantly to protect consumers from quality related failures. As compliance challenges mount, most organizations still manage regulatory issues in silos, raising the risk and cost of noncompliance and ultimately delaying the approval and launch of new products. To get through the labyrinth of testing and FDA approvals, companies need to build quality and compliance into business processes to manage variability and eliminate regulatory risks before they start.

Pilgrim Software has created a platform of integrated compliance management solutions that provide pharmaceutical companies with a sound, cost effective solution for increased productivity, risk mitigation, and ultimately accelerated innovation and product releases. Built on industry best practices and more than a decade of domain expertise, Pilgrim's Compliance Platform offers a powerful, fully integrated solution for internal/external assessments, nonconformance management, customer complaints, document management and SOP enforcement, employee qualification and certification, supplier quality, and equipment management.

Pilgrim’s solutions are highly scalable enabling you to implement the nonconformance and SOP enforcement capabilities you need today and add the other compliance capabilities as your needs grow.


Pilgrim's 21 CFR Part 11 Compliant solutions help Bio-Tech companies:

Resources