# Comments Submission: Docket 00D-1542

> June 14, 2002\
> Submitted by:

+-------------------------+---------------------+---------------------+
| > Paul Bleicher, M.D.   | Eli Hauser          | Kenneth O'Brien\    |
| > Ph.D.\                |                     | Director, Quality   |
| > Chairman, Chief       | Executive Director, | and Regulatory      |
| > Executive Officer     | Quality and         | Compliance -        |
| >                       | Regulatory          | Products            |
| > Phase Forward         | Compliance          |                     |
| > Incorporated\         |                     |                     |
| > 1440 Main Street\     |                     |                     |
| > Waltham,              |                     |                     |
| > Massachusetts 02451   |                     |                     |
+-------------------------+---------------------+---------------------+
|                         |                     | Michael Owings\     |
|                         |                     | Director, Quality   |
|                         |                     | and Regulatory      |
|                         |                     | Compliance -        |
|                         |                     | Services            |
+-------------------------+---------------------+---------------------+

> Phase Forward appreciates the opportunity to review and comment on
> this Guidance on Time stamps. In general, the Guidance directly
> addresses some important issues for the industry, and reflects
> standard practices and the FDA's experience. However, there are some
> areas that may need additional consideration. Our comments reflect our
> experience, and that of many of our customers, in the implementation
> of enterprise software for Internet-based clinical data management.

## Specific Comments

### 5.1 Time Stamp Accuracy

> **Comment:** The paragraph "Persons must use procedures and controls
> for time stamps under part 11 (as described above), designed to
> ensure, among other things, the authenticity and integrity of
> electronic records. Accordingly, procedures and controls should be
> implemented to ensure time stamps are accurate and reliable. It is
> extremely important for time stamps to be based on computer system
> clocks that are accurate and reliable.

We propose that item 5.1 should read: Persons must use procedures and
controls for time stamps under part 11 (as described above), designed to
ensure, among other things, the authenticity, integrity and
attributability of electronic records. Accordingly, procedures and
controls should be implemented to ensure time stamps are accurate and
reliable. It is extremely important for time stamps to be based on time
information that is accurate and reliable."

### 5.1.1 Synchronization

**Comment:** For the sentence "Computer clocks should be set correctly
and continue to be set correctly." Stating computer clocks is very
broad. Not all computer clocks will affect the time stamp attributed to
clinical data.

We propose that this should read: "Computer clocks that directly affect
the time stamp attributed to clinical data should be set correctly and
checked and adjusted periodically."

For the sentence: "You should establish and follow procedures to ensure
that computer clocks are set properly. For example, computers on a
network should automatically synchronize their clocks with that of a
designated network computer (e.g., as part of the process of logging on
to the network)."

We propose that the network \"master clock\" or timeserver should,
itself, be synchronized to a recognized timer service standard.

> **Comment:** For the sentence: "Computers not connected to a network
> should have their clocks synchronized to a recognized standard clock
> and should be periodically verified against the standard clock."
>
> We purpose that this should read: Computers not connected to a network
> should have their clocks synchronize to a recognized standard time
> service and should be periodically verified against the standard time
> service not less frequently than a log-in session.
>
> **Comment:** Computers not connected to a network should have their
> clocks synchronized to a recognized standard time service upon
> synchronization or log-in to the network system.
>
> We also propose that this requirement should only apply to computer
> clocks that affect the timestamp attributed to clinical data. This
> requirement should not apply to computers that do not affect any data
> time stamps.

### 5.2 Systems Clock Security

> **Comment:** The scope of the machines that need to be checked should
> be those whose time setting is used to create the audit trail time
> stamps within the database. Periodic checks of computer clocks can be
> accomplished manually or by an automated process.

### 5.5. Precision of Date and Time Expressions

> **Comment:** The audit trail and signature time stamps should be
> precise to the hour, minute, and second. There is a possibility of
> undetected fraud that could occur in the course of a minute.