Global Reporting Rule and Audit Capture Engine (GRRACE) is a revolutionary one stop engine useful for any pharmaceutical company undergoing a regulatory audit for its Argus safety system. It instantly provides the historical configuration details as required by the auditors and facilitates building efficient and effective reporting rules based on business and functional requirements.
What is GRRACE?
GRRACE is a web interface designed to allow a user to dynamically query an Argus database to access the Argus configuration information over a specified period or a particular date as required, during a partner or a regulatory audit.
GRRACE provides audit information related to a whole range of configuration information including, but not limited to Workflow rules, Study and Product Information, Reporting Rules, User and Group Configuration, Autolistedness, Advanced Conditions and any backend Audit data that otherwise requires complex database queries and specialized technical skills at the press of a button.
Dynamic Auditing for Configuration
GRRACE allows a user to dynamically select the areas for which audit information is required. This is in addition to the formatted standard output for configuration information for Workflows, Products, Studies, Reporting Rules, Users and Groups.
The information can be viewed on screen at the click of a button or exported to an excel spreadsheet or PDF for offline review and submission as required.
GRRACE provides a powerful feature for creating a reporting rule from the business and functional requirements.
A user can furnish the requirements with customizable identifiers and the reporting rule design information can generate the appropriate reporting rule along with necessary Advanced Conditions and SQL instantly. This can be then reviewed and updated as needed or viewed back to trace original requirements during an audit.
GRRACE platform allows tracking the correlation of all the advanced conditions in the system. It presents one single view of how an advanced condition is linked with a query set, a reporting rule or a workflow rule. This permits a user to track the changes made to an advanced condition and its implications on all associated regions in a single snapshot.
Advantages of GRRACE
Custom Configuration Review
The system configuration can be reviewed for custom parameters allowing easier and faster reviews and impact analysis for any change control or a custom component being introduced.
Extensible and Scalable
Configuration exports can be extended to create internal system and management reports for various purposes.
Configuration exports are available as desired and for dates and time selected at the run time.
Faster Decision Making
The solution can pre-empt complexity with a reporting rule to be developed using the captured business and functional requirements.
End to End Reporting
Single window for capturing and management of business and functional requirements and translating them into operational reporting rules to be applied on existing data.