Tissue and Blood Bank Corrective Action (CAPA) Software Systems

GMP 21 CFR Part 11, Part 211, and Part 606 Compliant Tissue and Blood Bank Corrective Action (CAPA) Software Systems for Automating Tissue and Blood Bank Processes

Corrective Action and Preventive Action (CAPA) - the overall effort to investigate and correct quality issues to prevent recurrence - is an important principle under the Current Good Manufacturing Practice (CGMP) regulations found in 21 CFR Part 606, which covers blood establishments. Such organizations can improve compliance and efficiency by implementing tissue and blood bank CAPA software systems.

Although 21 CFR Part 606 does not use the term CAPA directly, it states that all biological product deviations should be investigated in accordance with the applicable provisions of 21 CFR Parts 211 and 820, both of which require CAPA procedures.

MasterControl CAPA™
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