Industries > Life Health Sciences
| Blood and Tissue Quality, Risk & Compliance Solutions |
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
Smart Results...
Pilgrim Software provides valuable Professional Services to help ensure that your compliance program is a complete success. Pilgrim's expert staff of consultants provide everything from project management to system customization to validation and helping you minimize your risk and maximize your return on investment.
Some of Pilgrim's Blood and Tissue Customers
- American Red Cross
- Belgian Red Cross
- Blood Systems, Inc.
- Canadian Blood Services
- Florida's Blood Centers
- Florida Blood Services
- South Texas Blood and Tissue Center
- more customers...
More Information
E-mail
this page
Print This Page
|
