Date/time stamp

Automatically updating a date/time stamp on the HMI any time a PLC edit is made... 

Check priority/colour coding is appropriate Is alarm logged on printer with date/time stamp ... 

Procedures and controls shall include use of secure, computer-generated time-stamped audit trails to independently record the date and time of operator entries and actions that create, modify, or delete electronic records. 

To date, the WACHEM database contains 24,200 analyses made up of 323 separate analytical batches sourced from eleven laboratories. In order to maintain a dynamic database, the contents of available data are updated daily using a series of stored procedures, with each data download appropriately time stamped. 

Databases date and time stamp all information. This makes accidental overwriting of raw data and methods impossible. 

Written procedures and practices must be in place within the laboratory to verify the accuracy of manually entered and electronically transferred data collected on automated systems. The primary documentation for data entry requirements is an audit trail. Laboratories must ensure that an audit trail exists and is maintained. This audit trail must indicate date and time stamps for each record transmitted and the source instrument for each entry. 

Use of secure date and time stamp for the creation, modification, and deletion of data. 

The use of time-stamped audit trails (Part 11.10(c) and (e)) to record changes, to record all write-to-file operations, and to independently record the date and time of any network system administrator actions or data entries/changes. 

They must contain who did what, wrote what, and when (date and time stamp)... 

Analogous to a public notary, Digital Notary Services provide tmsted date-and-time stamp for a document, so that someone can later prove that the document existed at a point in time. May also verify the signature(s) on a signed document before applying the stamp. 

An audit trail is a journal recording any modifications carried out by the users, or by the processes operating on behalf of the user, to the electronic records. This mechanism provides the capability to reconstruct modified data and must not obscure the previously entered data. The tracking mechanism includes adding computer-generated date and time stamps to the record, to indicate when the record was modified, the types of modifications performed, and the identity of the person performing the modification to the record. 

The date and time stamp contained in this message conveys when CBER received your submission from the Electronic Submission Gateway. If your submission was received at CBER after 4 30 PM EST, the official receipt date for the submission is the next government business day. 

Event logging — date and time stamp synchronization... 

Once the corrected copies are received, the data manager makes the change in the clinical database. An electronic audit trail is maintained in the clinical database of all data entered and changed. This audit trail tracks the date and time stamp and the identification of the person making the entry correction or change. 

User-independent computer-generated time-stamped audit trails. Procedures should be available to use secure, computer-generated, time-stamped audit trails to independently record the date and time of operator entries and actions that create, modify, or delete electronic records. Record changes shall not obscure previously recorded information. Such audit trail documentation shall be retained for a period at least as long as that required for the subject electronic records and shall be available for agency review and copying. 

A date- and time-stamp mechanism that is independent of the control of the author or source of the electronic data. 

Authentication is usually performed by entering a unique user identification (ID) and password. If data are transferred automatically from external software, the source system either must provide a similar mechanism to identify a valid user or the external system has to log on to the record manager with a unique identifier. In any case, data that are entering a compliant-ready record manager require this identification. The authentication needs to be logged with a date and time stamp in an audit trail. The same requirement applies to the modification of data that already exist in the record, if the user is not already in an authenticated session. In fully regulated environments, a reason for the modification has to be supplied before changes can be made. 

Witnessing of electronic data is accomplished by routing electronically the file to the witness. That person will access the file, review its entire contents, and indicate that he read and understood the content by applying an electronic signature. The process is similar to the authentication performed with a unique user ID and a password. The system will automatically and independently provide a date and time stamp and will log this event. The file will then be routed back to the authoring party or the author will be sent an electronic notice confirming that the signature has been completed. 

The security of documents from an intellectual property (IP) standpoint is at the very least questionable. This applies particularly to patent relevant fields. According to U.S. patent policy, the date of invention is relevant for deciding who is the patent owner. This is different, for instance, from the European patent policy, where the date of filing the patent with the European Patent Office constitutes the patent ownership. However, creating documents on a local file system does usually not ensure the appropriate time stamp and does not allow applying electronic signatures, both of which are necessary for patent relevant documentation. 

Classical medical records have material not in any particular order, except for date and maybe time, in which case it is said to be time-stamped. Normally, however, e.g., one would create a separate entry such as PHSx resting pulse time=08/03/2004 11 46 00 or even PHSx resting pulse =time =08/03/2004 11 46 00 to go alongside PHSx resting pulse =time =70, and similarly for other items, so allowing time series analysis (effectively correlations between time of observation and the observed value).To do this requires conversion to some universal leap-year-free decimal time such as 2009.98666, which is some moment of December 2009 (there are also things called leap-seconds to take into account). 

The rule requires the use of secure, time-stamped audit trails. This provision is key for the FDA during validation, tests should be run to ensure that each record is time and date stamped. The question has arisen "which time " Mr. Paul Motise has been unequivocal in stating that the time must be local time, though this will cause some confusion across time zones and may impact company policies on time recording. The case for international time stamping has been eloquently argued by Ken Chapman and Paul Winter [3] in a "white paper" they have recently made available. 

Timeless. It is important to include a number of time stamps in these data. These should include the date the request was received, data assigned, and date completed. 

Time stamping many operating systems store a date of last modification for each file. If a user separately and incorruptibly stores the date of last modification for important files, discrepancies can indicate possible infiltrations. 

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