Sympatec’s Contribution to Compliance

Sympatec prepared a Rule 11 checklist with:

• answers to a potential auditor’s questions about our systems with respect to compliance,

• instructions how to use the WINDOX Rule 11 features properly,

• proposals of additional measures that the pharmaceutical company should take.

How does WINDOX 5 support Rule 11 compliance?

Operating system:

To ensure the correctness of the user identification, an operating system with access control (Windows 2000^TM or XP Professional^TM) is used.

WINDOX 5 standard features (always enabled regardless of the database “FDA Rule 11 mode” setting)

• WINDOX 5 has been developed under conditions of Life Cycle Development Quality Control. This is a precondition for Rule 11 compliance.

• Data integrity is enforced by the WINDOX 5 database.

• WINDOX 5 stores user, date and time with every data record.

• WINDOX 5 keeps an administration log in which all administrative action (e.g. disabling of “Rule 11 mode”) is recorded.

• WINDOX 5 is downward compatible to WINDOX 4 and 3. This ensures the restoration of archived data even if, for very old data, in two steps (HELOS/DOS, WINDOX 3, WINDOX 5).

Additional Measures (features supplied but disabled by default, or options to call)

WINDOX 5 has a database property “FDA Rule 11 mode”, enabling the write protection of measurements and an audit trail of admitted modifications of data.
Compliance can also be supported by the proper assignment of user rights.
WINDOX 5 comes with an optional digital signature. Measurements can be reviewed and signed by someone other than the operator.