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ClockWatch and FDA 21 CFR Part 11
The FDA Regulation 21 CFR Part 11 requires electronic documentation of clinical testing. A component of this is the Time Stamp Guidance Docket OOD-1542, which requires an accurate time stamp for every log. To accomplish this you must have controls in place to ensure your computer system's time and date are correct.In 1997, the FDA issued a regulation called 21
CFR Part 11 that governs electronic records, electronic signatures, and
hand-written signatures executed to electronic records. Part 11 also governs
several types of electronic records, including operation and recipe files.
Implicit in this regulation is the need to set an maintain the computer to the
exact time:
[Paragraph] 11.10(e) 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. 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.
ClockWatch offers the time accuracy needed to meet this requirement. ClockWatch can be easily integrated into your existing setup to operate independently and automatically. We have synchronization solutions using the Internet, modem dial-up, or GPS. ClockWatch Sentry lets you lock the computer clock to prevent tampering.
DocuClock provides a physical time stamp on paper that is traceable back to the NIST Atomic Clock.
The table below can help identify the best solution for your needs.
| Situation | Specifics | Solution |
| Maintain Single computer at correct time | Single computer, Internet or modem-dial up connection available | ClockWatch Pro |
| Locking clock from unauthorized changes desirable. | ClockWatch Sentry | |
|
Maintain Computer Network at correct time
|
Network
with less than 20 clients, Internet or modem-dial up connection available
for the server |
ClockWatch Server and Client |
| Network with less than 20 clients, Internet or modem-dial up connection NOT available for the server | ClockWatch
Star Sync bundled with Client or ClockCard Server bundled with ClockWatch Client. |
|
| Network
with 20 clients or more, Internet or modem-dial up connection available
for the server |
ClockWatch Enterprise | |
| Network with 20 clients or more, Internet or modem-dial up connection NOT available for the server | ClockWatch
Star Sync bundled with Enterprise or ClockCard bundled with ClockWatch Enterprise. |
|
|
Stamp
date and time on paper |
Time stamp recorded to paper receipt |
DocuClock date/time stamper |
Contact Beagle Software at 1-877-845-2549 (toll-free US and Canada) or 612-370-1091 for more information.
ClockWatch Main Page
Star Sync Main Page
Enterprise Main Page
DocuClock Main Page
ClockCard Main Page
