21CFR11 Compliance for Spraytec

Version 2.0 of the software for Malvern’s new Spraytec system introduces several new features which provide users in the pharmaceutical industry with the ability to achieve compliance with 21 CFR 11 – the FDA's document outlining the requirements for electronic data storage and tracking.

Authority Checks
A security system similar to that used in Windows XP™ is now available within the Spraytec software, requiring users to login prior to making measurements. This includes:

	User and Group Specifications: allow specific measurement and data analysis permissions to be assigned for each user of the Spraytec system.
	Password Aging: can be applied to force users to change passwords after a pre-defined period of time.
	Password History: can be stored for each user in order to prevent use of the same password when a change is requested.
	Account Lockouts: occur automatically following the entry of a pre-defined number of incorrect passwords for a given user.
	Continuous Use Checks: allow the automatic logout of a user following a period of inactivity.
	Account Disabling: used to prevent access to an account should a user leave the company or change roles.

Automatic Back-up Creation
Key processes such as data deletion and modification are still available when the 21CFR Part 11 software options are enabled, although access to these operations can be controlled using the security system. The user is required to provide a reason for the action when these processes are carried out and an automatic backup of the measurement data is made. This ensures that the results recorded prior to any changes or deletions can be reviewed.

Creation of Audit Trails
All key measurement and data analysis activities are logged to a system audit trail file. This lists the event that has occurred along with the username of the user involved. For key events such as data modification and deletions the user is prompted for a reason for the action, which also appears within the audit trail. The current user can also add additional comments to the audit trail in order to flag key events. Audit trails can be created daily, weekly or monthly to meet the requirements of the customer's operating policies.

Versioning of SOPs
Automation of measurements using the Spraytec system is accomplished by the creation of software measurement routines known as SOPs. These routines are automatically stored along side the size history data and can be extracted for critical evaluation or review. Version 2.0 software now provides an audit trail which records changes to SOPs. Reasons for change are requested by the software and the differences between versions can be compared in tabular form.

File Locations
When operating in a 21CFR 11 compliant environment, it is important that all the data files created by the Spraytec software can be backed-up to a secure location. To enable this to be done, the location of all of the key Spraytec data files can be set to a network location.

Electronic Signatures
Electronic signatures are supported by direct printing to Adobe Acrobat PDF files.