21 CFR Part 606 - Current Good Manufacturing Practice For Blood and Blood Components

Within 21 CFR Part 606, Sub Part F, Section 606.100, there is a clear instruction that written SOPs shall be maintained and available within all locations where the procedures are performed. This is simplistically accomplished within iPassport, all controlled documents (SOPs, policies etc) are securely stored within iPassport and under full version control including a fully traceable audit log of change events, and as iPassport is a pure Internet based application it means all staff that have access to the Internet can access iPassport no matter what their location.

In addition to maintaining controlled documents 21 CFR Part 606 requires that the laboratory monitor the reliability, accuracy, precision, and performance and there is no better way to perform this task than through the use of the quality audits function within iPassport. The iPassport audit module allows you to easily schedule audits, which can then act as recurring events making follow‐up audits easy to plan and with the ability to design the audit to fit your requirements it is simple to measure any variable.

The audit feature is one of the key components of the quality management module along with the non‐compliance (capa) facility, 21 CFR Part 606 does not use the term 'corrective and preventative actions' within Section 606.171 but it does ask for all "biological product deviations" to be "investigated in accordance with the applicable provisions of Parts 211, 606 and 820 of 21 CFR Part 606". And, Parts 211 and 820 do call for the establishment of a corrective actions and preventative actions (capa) system.

So from this information it is easy to see how iPassport can assist with your 21 CFR Part 606 requirements.