Mastersizer 2000 and 21 CFR Part 11

Version 5.1 software for the Mastersizer 2000 introduced the following features to provide users in the pharmaceutical industry with the ability to achieve complete 21 CFR Part 11 compliance:

Improved authority checks
Windows NT-type security features are now included in the application itself. These features include:

	Password aging where the password will automatically expire after a predetermined period.
	Continuous use check and security screensaver – logs out users after a configurable period of inactivity – measurement routines in progress at the time of logout are unaffected.
	Automatic account lockout after a configurable number of failed attempts at entry.
	Configurable password history log to enforce use of different passwords.
	Ability to set up and enable groups with different privileges – 23 different privileges can be assigned as appropriate.
	Accounts can be disabled but not deleted when users leave the company or change their roles. Disabled accounts can be re-enabled by the administrator.

Deletion of records can be prohibited.
Deletion of records is allowed but the security can be configured to prohibit record deletion by certain groups. In circumstances where records can be amended, a reason for change is demanded by the software.

Users can log-out without closing the application.
If a privileged user logs out, all access privileges are automatically revoked until the next user logs-in. The application does not close down.

Creation of Audit Trail file.
All activities which create or modify records or affect system security are recorded in a file which can be exported but not deleted.
Audit Trail Files can be created daily, weekly or monthly to meet the requirements of customers IT standard operating procedures.

Versioning of software SOPs.
Automation of measurements using Mastersizer 2000 software is accomplished by the creation of measurement routines known as SOPs. These routines are automatically stored with the measurement records and can be extracted for critical evaluation or review. From Version 5.1, the software provides an audit trail which records changes to SOPs. Reasons for change are requested by the software.
Differences between versions can be compared in tabular form.

Import of Mastersizer X, Mastersizer S, Micro and Microplus record files.
Records produced using Mastersizer X, Mastersizer S, Micro and Microplus can be imported into Mastersizer 2000 software to provide a read-only reference for comparisons and archiving purposes.

More information:

	21 CFR Part 11 user guide