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Q. What platforms does DMSys run on?
A. DMSys can be installed on any computer running Windows 2000 or later.

Q. Is DMSys fully GCP and 21 CFR Part 11 compliant?
A. Yes. First, DMSys is fully validated. This does not simply mean that it has been thoroughly tested; its development has also been fully documented.

Second, DMSys provides a complete audit trail. For any data entering the system through first data entry, verification (second data entry) or the data import function, an audit trail is maintained. Additionally, a full audit trail is maintained for any corrections and changes to data including the reason for making the correction.

Third, DMSys incorporates all the security features required by GCP and 21 CFR Part 11. Every authorized user must have a user name and password; both have to be recognized by the system before they can log in. Users are required to change their passwords at regular intervals. A record is kept of all user log-ins and log-outs, with the name of the user, and the date and time of all user log-ins and log-outs, with the name of the user, and the date and time they entered and exited. Each functionality and individual study in DMSys is protected. A user must have the authorization in their user access profile to access each specific function and study in DMSys, so that, for example, a user who is not authorized to enter data corrections is unable to do so.

Q. How is double data entry done in DMSys?
A. Verification (double data entry) can be performed interactively or non-interactively. In both cases, two distinct data files are created.

In non-interactive verification, the second data entry operator never sees the entries made by the first operator; data entry and verification are identical processes. After completion of verification, DMSys provides the facility to compare the entries made by the two operators, and print out any discrepancies (including any records present in one field but missing from the other).

In interactive verification, the second data entry operator does not see the entries made by the first, unless a different value is entered. Then, the operator is presented with three options: to re-edit the value, to accept the original value, or to accept the second value.

Q. Are character values checked when comparing values entered originally and on verification?
A. When comparing the values entered in non-interactive verification, memo fields (character fields of unlimited length) can be excluded. In interactive verification, all fields are compared.

Q. Is double data-entry required by DMSys?
A. No. If you are conducting or managing a study for which you believe double data entry to be unnecessary, you do not have to do it. In validating data, creating master files, and many other procedures, DMSys looks for verification file, but if it cannot find one, it defaults to the data entry file.

Q. Does DMSys allow data checking during data entry?
A. Yes, DMSys does provide the facility to perform range checks on data during data entry. It's an option that can be switched on or off. When it's switched on, the user is notified of any out-of-range values. The user can then immediately re-edit the entry, if the out-of-range value is a data entry error. However, since GCP requires the data entry operator to enter exactly what is written on the CRF, the operator can also leave the out-of-range value in place to be picked up by the validation checks run after completion of data entry.

Q. Does DMSys provide any management metrics
A. Yes. During data entry and verification (both interactive and non-interactive), the time taken to enter each record is recorded in the 'history' file. In interactive verification, the number of discordant values and the number of modifications per record are also stored, and can be browsed or printed if wished.

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