Blood, Biologics, and Tissue Banks

Case Studies Describes How to Automate Blood Bank Quality Systems to Ensure Compliance and Improve Efficiency

Newly released white paper, Software Automation in the Blood and Biologics Industry, outlines various types of software commonly used in regulated life science environments. The white paper's overview of solutions includes information regarding the purposes of various solutions as well as their respective pros and cons.

The FDA maintains a complete database of human cells and tissue-based establishments and their products which will increase their base of knowledge about these establishments and products, thus heightening quality requirements and regulations. There is not a better time to improve quality processes than the present to ensure compliance and product safety and efficacy.

Watch Videos Community Blood Center of the Carolinas (8:05) How MasterControl Makes Your Job Easier (3:50)

Regulatory Requirements for Blood and Tissue Orgs

Blood banks, transfusion centers, and tissue banks are covered by a number of regulations, including the FDA's 21 CFR Parts 600, 606, 21 CFR Parts 210-211, 21 CFR Parts 1270-1271, 21 CFR Part 11 (for those maintaining electronic record-keeping systems), and the Clinical Laboratory Improvement Amendments (CLIA). In addition, many blood establishments affiliated with hospitals, adhere to quality standards by the College of American Pathologists, a professional organization that provides voluntary accreditation.

Blood and Tissue Quality Challenges

A blood establishment's ultimate goal is to ensure blood quality and safety. To achieve this goal, the organization must address many challenges, including:

• Inefficient Quality System: Blood and Tissue establishments with multiple facilities and employees in different locations may find it cheaper initially to maintain separate quality systems, especially paper-based or hybrid systems. In the long term, however, these systems are inefficient, requiring tremendous man-hours in terms of routing SOPs, donor records, and other documentation, obtaining approval and signatures, face-to-face meetings to discuss changes, and manual search and retrieval of documents during inspections and accreditations.
• Disconnected Processes: Quality processes that are not connected to each other can cause delays and poor results. For example, a corrective action process that's not connected to the rest of the quality system may produce an unreliable root cause investigation due to inadequate information.
• High Cost of Validation: 21 CFR Part 11 requires computer system validation as a way of ensuring the integrity of electronic records and signatures. Even if a blood establishment successfully automates its manual SOP management and other record-keeping systems, it still faces the daunting work and the high cost of validation. Labor-intensive validation tests conducted by internal staff and exorbitant consultant fees can easily double a company's compliance cost.

MasterControl Integrated Quality Management Software Solution

Compliance is a state, not an event. Companies part of the American Association of Blood Banks AABB, must not only attain compliance, but sustain it year after year. The MasterControl integrated quality management suite is a configurable, easy-to-use solution that helps companies attain and sustain compliance with FDA and other regulations by automating and managing quality processes in an efficient and cost-effective manner.

Recognizing that validating a software solution and keeping it in a constant state of validation is half the battle in sustaining compliance, MasterControl is actively developing new ways to reduce the time and effort involved in validating a system and to make it easier to validate software upgrades, both of which are essential in lowering overall validation cost.

Contact a MasterControl Representative

Contact a MasterControl representative to learn more about the software technology that can greatly assist blood bank technology experts and the blood industry in general.