Blood & Tissue - Risk, Compliance and Quality Management Solutions

Overview

Overlapping safeguards implemented by the FDA protect patients from unsafe or unsuitable blood and blood products. In addition, the FDA has significantly increased its oversight of the blood industry. According to the FDA's CBER Website (www.fda.gov/cber/blood.htm), inspections of blood facilities are performed at a minimum of every two years. "Problem" facilities are inspected on an even more frequent basis.

Noncompliance with FDA requirements can have severe consequences for blood organizations including:

FDA Warning Letters
Consent Degrees
The revocation of a firm's license to manufacture and distribute blood products

Pilgrim Software's fully Web-based Compliance solutions help blood services organizations maintain compliance with FDA regulation and AABB 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 21 CFR Part 11 compliant solutions help blood services organizations:

Maintain strict adherence, with full management visibility, to FDA and AABB (American Association of Blood Banks) requirements
Support CFR 606/current Good Manufacturing Practices (cGMP) across the product lifecycle
Effectively track corrective actions/preventive actions (CAPA) and customer complaints from incident recording through final sign-off
Provide the top-down, cost-effective enforcement of SOPs best practices
Reduce lead times to create, approve, release and revise SOPs
Provide Biological Product Deviation Reporting (BPDRs) to the FDA on a timely basis

Some of Pilgrim's Blood and Tissue Customers

American Red Cross
Belgian Red Cross
Blood Systems, Inc.
Florida's Blood Centers
Florida Blood Services
South Texas Blood and Tissue Center
More Customers...

Resources

Industry Information

Brochure - Blood Services Industry

Customer Information

White Papers

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.