System Access Manager

Advanced user management

get the ultimate in system security The System Access Manager is an optional account management module that strengthens your case for compliance by managing and maintaining user access to Perceptive Instruments software products such as Comet Assay IV. The System Access Manager will be of particular benefit to clients who are required to comply with GLP, GMP and the FDA 21 CFR Part 11 Final rule on Electronic Records and Electronic signatures.

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  • Manages unique electronic signatures in line with the principles set down by the FDA and OECD
  • Secure user management module is entirely transparent and invisible to end users
  • Full and detailed audit trails record all login attempts and changes to user accounts
  • Highly configurable user account rules including minimum lengths for electronic signature components; account validity and program access permissions
  • Enforce regular password changes and set rules on password reuse
  • Login timeouts and lockouts to prevent unauthorised access
  • Comprehensively tested and validated in accordance with our Quality Management System which is approved to ISO 9001:2008 incorporating ISO 90003

Manage users in a compliant environment

Individual users are assigned unique user IDs and access rights to each product. The program manages user access via a wide range of password rules including expiry, length, use of characters and numbers and more.

User Administrators can add new end users to the database and assign them a unique User ID, a User name and duration of password validity as well as defining a specific access level and login time-out to each product.

A randomly generated password is communicated to the individual who then changes the random password into their own case sensitive text using an Update password utility. This ensures that the password is known only to the end-user concerned and, in conjunction with their User ID, constitutes the unique electronic signature.

Audit all login events and user profile changes

The System Access Manager provides comprehensive security and full audit trails which record all login attempts and changes to a user's account validity or access permissions. The audit trails can be filtered on any field, such as User ID, event description or date. Audit trails can then be exported to Excel for printing or review.

Every login event or alteration to an account is recorded in the audit trail along with the current logged on Windows user account, so it is possible to record which users have logged in, when they logged in and what actions they have taken. The main program is protected by a password, ensuring only authorised personnel can gain access to it.

The System Access Manager is built around a secure Oracle database, providing complete security of user and audit data.

If you are interested in finding out more about the reporting and auditing features of the System Access Manager, and how you can benefit from the enhanced the level of security the program provides, please contact us.

System Access Manager
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