From PilgrimSoftware.com
General FDA-Regulated
By
Oct 25, 2005,
15:38
No matter what compliance or quality regulations are required for your organization – whether FDA CFRs, GxP, ISO, or Sarbanes Oxley, Pilgrim’s SmartSolve solution can help organizations streamline their processes to reduce costs, improve quality and meet regulatory requirements.
Organizations like the FDA Center for Biologics, Drugs and Devices as well as the EU and other ministries of health are having stronger enforcement policies requesting compliance and quality strategies and roadmaps and access to documented records, procedures, and specifications as well as summoning people to answer and be accountable for specific issues. With any new complaint or product recall, life sciences companies are on these organizations radar for an audit. Why?
- Increased number of regulated products and a greater role of such products in overall health care
- Increased number of warning letters, 483s, citations, and product recalls
- Increased frequency of required FDA inspections with fewer resources available resuling in tighter inspections
- Advances in medical sciences, manufacturing and quality management technologies
- And Globalization of the industry
The most important theme from these citations and regulations is the need for a lifecycle approach to regulatory compliance. Most companies have some stage of quality systems & assurance to fulfill quality and regulatory compliance. However, most of these compliance and quality activities lack real-time visibility and have the inability to enforce standardization across the organization and typically have insufficient closed loop processes. And in some cases the cost associated with adhering to industry regulations can be seen as a necessary evil. With pressure mounting from the FDA for risk-based planning and management to better control product safety and overall quality throughout the process, Life Sciences companies can meet the challenges of this changing compliance landscape by adopting a robust quality program and key components to automate compliance across the entire organization.
Pilgrim Software has created a platform of integrated compliance management solutions that provide Life Sciences companies with a sound, cost effective solution for increased productivity, risk mitigation, and ultimately accelerated innovation and product releases.
Pilgrim Software's fully Web-based Compliance solutions helps regulated organizations maintain compliance with FDA regulation and requirements. 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 solution 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 FDA regulated companies:
- Implement a closed-loop system for receiving, processing, tracking and solving customer complaint issues
- Take a risk-based approach to managing nonconformances, deviations and change management and prevent recurrence
- Reduce the cost of compliance, while fully meeting FDA requirements
- Enforce policies and procedures
- Improve high-level oversight to reduce management liability
- Monitor, report and audit governance and compliance including Sarbanes-Oxley
- Streamline FDA adverse event reporting
Smart Results...
Pilgrim Software provides valuable Professional Services to help ensure our staff of consultants provides everything from project management to system configuration and tailoring to validation – helping you minimize your risk and maximize your return on investment.
Some of Pilgrim's FDA regulated customers
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