Users can enable the optional Empower Authentication feature, which restricts system access to users with Empower credentials and records all system activities performed by those users.
Starting with version 2.0, Alliance iS HPLC system software includes the option to set up system access control from the touchscreen. By default, this feature is disabled. Your company decides when to enable this feature at its discretion. See the Alliance iS HPLC Systems Instrument Control Software 2.0.0 Installation and Configuration Guide (715009941) for more information on configuring this feature. When enabled, this feature requires all users to enter their Empower username and password to access the system. After login, the system records all user activities to the system log and attributes them to the logged-in user. Users can view these logs from the system touchscreen and can view and download them from the console. See Viewing system logs. When you enable this feature, the system can also record event logs in the Empower audit trail. You enable this option when you configure the feature from the touchscreen. The system logs and stores all user actions for a period of 13 months.
Note: The console app recognizes the user logged into Empower. The user logged into Empower is independent from the user logged into the Alliance iS system via the touchscreen. The system attributes all activities performed from the console to the logged in Empower user and all the activities performed from the touchscreen to the system/touchscreen user.
Empower administrators create user accounts from Empower, then assign users to user types that categorize individuals based on their job roles within the laboratory. All users within the same user type share the same set of privileges, because Empower does not support assigning privileges to individual users. Assigning user types to individual users automatically grants them the privileges defined for those types. Designated users with the proper authority are responsible for mapping Empower user types to Alliance iS system user types. Lab analysts, lab managers, and service personnel are assigned different levels of access to system features.
The Empower Authentication feature offers additional benefits to a laboratory working in a regulated environment. When combined with your company's standard operating procedures, Empower provides you with the means to make your regulated laboratory meet the intent of regulatory practices and rules. See Using the Alliance iS HPLC system in a regulated environment and The Role of Empower Chromatography Data System in Assisting with Electronic Records Regulation Compliance (720004926EN).
Tip: If you work in a regulated environment, system administrators can follow your SOPs to select the recommended settings for GXPs, signatures, or both, to assist in compliance with FDA Rule 21 CFR Part 211 or Part 11. If you work in a non-regulated environment, choosing the GXPs, ES, or ER/ES settings is optional.
Empower maintains system and data integrity through built-in record keeping and audit trail reporting. These features also support compliance with regulatory requirements when needed. See Audit trail information in Empower. Empower automatically generates secure and time-stamped system audit trails that track any user who performs system-level activities that create, modify, or delete a record, such as when a user account is created, modified, or deleted. Empower also maintains a separate project audit trail that generates secure and time-stamped records of any user who creates, modifies, or deletes samples, methods, or results within a project. Audit trails provide you with a complete record to reconstruct the electronic events in your lab. You can configure the system to prompt users for their passwords whenever they create, modify, or delete a record or item, ensuring the integrity of your sample, method, or result information.
For more detail on user accounts, privileges, and policies in Empower, see Audit trail information in Empower, Alliance iS HPLC system audit trail, and the following Empower online Information System topics:
- "Creating user accounts"
- "Creating user types"
- "Managing user types, privileges, and groups"
- "Setting Empower system policies"
- "Setting system policies for a regulated environment"
- "Setting privileges and rules for approving reports"
- "Generating reports"
- "Approving reports"
- "Viewing approved reports"
See also:
System features
