Pharmaceuticals and Bio-Tech - Risk, Compliance and Quality Management Solutions
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Overview
Pharmaceutical and Bio-Tech companies are under increased pressure to get products to market faster and more efficiently. The challenges related to speed-to-market, while meeting strict regulatory requirements, are severe. The Pharmaceutical and Bio-Tech industries have kinship where many of the drugs that large Pharmaceutical companies produce come out of Bio-Tech companies. Many Pharmaceutical companies have also acquired Bio-Tech companies or start their own Bio-Tech branch.
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:
- Implement a closed-loop system for receiving, processing, tracking and solving customer compliant 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
Some of Pilgrim Software's Pharmaceutical and Bio-Tech Customers:
- Ariad Pharmaceuticals
- Avecia
- Bristol-Myers-Squibb
- Genzyme
- Gilead
- Hospira
- Pfizer
- More Customers...
Resources
Customer Information
Video Testimonial - Cynthia Pleach, Stryker Biotech
Testimonial Transcript - Cynthia Pleach, Stryker Biotech
Success Story - Complaints & Adverse Event Management in a Combination Product Pharmaceutical Company
White Papers
21 CFR Part 11 White Paper
21 CFR Part 210-211 White Paper
Quality in the Global Pharmaceutical Supply Chain White Paper
Why Pharmaceutical Supplier Quality Management Presents Special Challenges for Risk Management White Paper
Recorded Webinars
Drug & Device Off-Label Promotion Webinar
Determining the FMV of Thought Leader Compensation in the Life Sciences Industry Webinar
Enabling Electronic Submissions to Accelerate Product Approvals and Time to Market Webinar
Best Practices for SPL R4 Compliance Webinar
Lessons Learned from the implementation of eCTD in Canada, Europe and U.S. Webinar
The Enterprise Risk, Compliance and Quality Management Platform
Pilgrim Software provides a centralized, enterprise–wide, fully web-based solution for managing adverse event reporting, change control management, complaint handling, corrective and preventive actions, document control and content management, engineering drawing control and collaboration, employee certification and training, equipment maintenance/calibration, internal and external audits, nonconformance management, process management, regulatory submissions, risk management, SOP enforcement, and supplier quality management.
This powerful platform enables you to manage product safety while complying with regulatory requirements; reduce manufacturing and operational costs; increase overall productivity; and, improve customer satisfaction by managing the critical processes that govern your organization.