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A key success factor for a CCS is a gapless docu­men­ta­tion. Just talking about 21 CFR Part 11 or audit trail is not suffi­cient anymore. It’s more about the overall life­cycle of data gener­ated, about raw data, meta data et cetera.
Due to the increasing demands in data manage­ment and data integrity e.g. ALCOA or ALCOA+ prin­ciple and other regu­la­tions, the effort for compliant docu­men­ta­tion is perma­nently increasing. A serious number of concerns and warning letters from the FDA are related to data integrity viola­tions.
To avoid these concerns, automa­tion is an impor­tant part of the docu­men­ta­tion strategy. Through automa­tion of key process steps, fully compliant docu­men­ta­tion systems can easily be imple­mented. Avoiding manual processes releases the user from time consuming and error prone manual docu­men­ta­tion.
With the AQU@Sense MB, one of the last manual proce­dures, the bioburden analysis, can now be fully auto­mated. No manual sampling, no manual sample prepa­ra­tion makes this tool the ideal solu­tion for fully auto­mated docu­men­ta­tion. In combi­na­tion with the elec­tronic control features of the AQU@View, all data are collected, logged and visu­al­ized at one point and can be exchanged with the labo­ra­tory infor­ma­tion system or any other control unit.