| Comment Record |
|
Commentor |
Mr. Robert Pettersson |
Date/Time |
2002-12-03 08:17:56 |
|
Organization |
H. Lundbeck |
|
Category |
Company |
| Comments for FDA General |
| Questions |
|
1. General Comments
|
Docket Number: 00D-1539
Comments on Draft
“Guidance For Industry, 21 CFR part 11; Electronic Records; Electronic Signatures”
Maintenance of Electronic Records
Lundbeck situated in Copenhagen, Denmark concludes the following questions and comments to the drafted document:
(The input is divided according to the sections in the document)
Section 5.5 The Ability to Process An Electronic Record’s Information Throughout Its Records Retention Period Should be preserved.
Section 5.5 says:
“By being able to process the information, you would maintain the ability, for example, to effectively and efficiently reconstruct events,”
Lundbeck comment:
Some would say that that the Agency is raising the compliance level considerably by requiring information to be re-processable. In traditional paper systems, re-processing has never been possible in the native software. This requirement is new and will force huge expenses on the industry. If You take the example of a Chromatography Data System used to obtain drug concentrations in plasma in clinical or non-clinical studies, to ensure the re-processing capability and the ability to “efficiently reconstruct events”, over an extended period, would almost certainly force the time capsule approach for multiple versions of the software. Please agree that it would be satisfactory to print electronic records in such systems (either to 1. Paper, 2. An electronic “paper format” e.g. PDF, or 3. Some kind of searchable electronic “paper format” i.e. the “Nugenesis”-approach) providing that metadata and audit trail information is included/displayed with or by the electronic records and providing that the process is validated.
Section 6.1 The Time Capsule Approach
Lundbeck comment:
The time capsule approach is an extremely expensive solution, and is combined with great effort. Some systems can be impossible to maintain/repair due to lack of spare parts; it is therefore difficult to see if “the time capsule approach” could be applicable.
Thus, Lundbeck suggest that the time capsule approach should be removed from the guidance document.
Section 6.2.1.1 Information Continuity Should Be Preserved
Section 6.2.1.1 says:
“Someone who reviews the migrated electronic records should be able to reconstruct events to determine if the predicate rule was followed (e.g., who did what, when, how, production values and conditions, study observations and findings)”
Lundbeck comment:
If the meaning of this sentence is similar to requiring an audit trail according to 21 CFR part 11.10 (e), please use the word “Audit Trail”, in order to avoid confusion.
|
|