|2004N-0133 - Part 11 Public Meeting; June 11, 2004|
|FDA Comment Number :||EC17|
|Submitter :||Mr. Gregory Gogates||Date & Time:||06/23/2004 06:06:10|
|Organization :||CRF inc.|
| 11.10 implies, and CSUCT discusses, electronic source records. There has been some discussion about the need to retain the original source object(s). FDA CPG 7150.13 alows for certified copies but I believe there needs to be some clarifications with regard to this included in the new P11 guidance.
Specifically there should be discussion to allow the 'migration' (source ISO-12207 clause 5.5.5) of data between computing environments in a validated manner. Typically, Data Migration is reserved for upgrading computing environments but should also be recognized as valid for normal data flow between, or within, computing environments. This transfer or migration of e-source data should be specifically discussed and allowed in the new guidance.
Additionally, the 'store-and-forward' computing environments, such as lab instruments, factory instrument, and electronic patient reported outcome devices, should be classified as 'Transient Data Collectors', or other such name, that truly describes thier nature. This is discussed in more detail in both the (PDA/ISPE 'Good Practice & Compliance for e-records and signatures part 2' section 4.5 transient data -2001) and the Electronic Data Management Forum 'eSource position paper' - April 2003 - attached)
Please consider these comments for incorporation.
VP Quality Management & Regulatory Affairs