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System Access Manager

System Access Manager users and permissions

User control for GLP and FDA CFR 21 part 11 compliance

  •  Manages unique electronic signatures
  • Secure user administration module
  • Full and detailed audit trails
  • Highly configurable user account rules
  • Enforce password changes and rules on password re-use
  • Login timeouts and lockouts to prevent unauthorised access
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Manage users in a compliant environment

System Access Manager is an account management module which strengthens your case for compliance by managing and maintaining user access. System Access Manager will be of particular benefit to those who are required to comply with GLP, GMP and the FDA 21 CFR Part 11 Final rule on Electronic Records and Electronic signatures. With full integration between System Access Manager and all Perceptive Instruments products, such as Comet Assay IV and Ames Study Manager, a fully compliant arrangement is achievable.

Password rules and electronic signatures

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 with a unique User ID, a User name and duration of password validity as well as defining a specific access level and 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.

Comprehensive audit trails record all login events and user profile changes

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 name of 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 where user accounts are managed is itself protected by a password, ensuring only authorised personnel can gain access to it. System Access Manager is built around a secure Oracle database, providing complete security of user and audit data.


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