Cleanroom Routine Environmental Monitoring – FDA Guidance on 21CFR part 11 Data Integrity

Despite guidance from the FDA, cleanroom environmental monitoring remains an intensely manual process, with many opportunities for human error to create gaps and errors in the data. In its 21CFR part 11 guidance, the FDA have given recommendations on what good data integrity looks like. This and this white paper explains the FDA’s advice in the context of current cleanroom environmental practices and shows how FDA guidance can be applied to improve data integrity.