Compliance Regulation 21 CFR Part 606

Decoding Compliance: Reg 21 CFR Part 606

Learn to Navigate Regulatory Standards & Address their Complexities

The growth of blood and blood component organizations depends on their ability to address key challenges. Donor recruitment, safety and quality, and cost-effective regulatory compliance are critical components that when mismanaged, can severely damage public trust. Overcoming those challenges can be tremendously difficult, particularly when processes are hampered by cumbersome, inefficient management operating systems.

However, today blood organizations are able to more readily ensure compliance with requirements for quality management systems according to GMP. By effectively streamlining all quality and compliance activities, these enterprises are able to protect one of the world's most precious resources - life-giving blood.

With stronger enforcement from the FDA Center for Biologics and American Association of Blood Banks, organizations need to setup integrated compliance systems and quality programs to address the regulations and improve performance and efficiency.

In this free white paper, we've compiled all the information you need to meet industry challenges head-on, thereby strengthening the mission to provide safe, reliable products and to ensure those products are available when needed.

Understanding current regulations and knowing how best to adhere to them is critical. Empowered with knowledge, blood organizations can ensure the security of both their bottom line and their patients' safety.

This Industry Regulation White Paper provides a concise look at those specific subparts of 21 CFR Part 606 that can be supported through cost-effective automation by:

Meeting quality and compliance audit requirements
Maintaining employee training and qualification history
Maintaining equipment records and calibration procedures
Managing SOPS and facilitating document access
Identifying issues affecting the organization and providing traceability ensuring proper resolution has been reached

To receive your free white paper from Pilgrim Software, simply complete the short form below and you will be immediately directed to a page where you can download.

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