Advanced
user management
System Access Manager
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 Sorcerer. 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.
Features
- 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.
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