Global Reporting Rule and Audit Capture Engine (GRRACE) is a system that aims to change the face of all regulatory, partner and corporate audits for the pharmaceutical industry as whole. It will revolutionize the way a pharmaceutical company will approach a regulatory audit in future.
GRRACE not only instantly provides the historical configuration details as required by the auditors, it builds the necessary information pool for the organization to maintain its reporting rule design more effectively and efficiently.
GRRACE can save over 90% effort and time spent in fetching data for custom configuration parameters during an audit and helps achieve over 50% reduction in the turnaround time for requirements to be implemented as an active reporting rule in a production environment. In addition, this system can be easily extended to include the followings:
- Audit case data including custom DLP based on the customer requirements.
- Provide an interface for all custom change control changes
- Can become a gold configuration database to push configuration changes in any environment
GRRACE allows a user to dynamically select an area for which audit information is required in addition to the formatted standard output for configuration information for Workflows, Products, Studies, Reporting Rules, Autolistedness, Advanced Conditions, Users, Groups and any backend Audit data that otherwise requires complex database queries and specialized technical skills.
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, collated for a period of time or a particular date, as required during a partner or a regulatory audit.
REPORTING RULES ENGINE
GRRACE provides a powerful feature for creating a reporting rule from the business and functional requirements and allows a user to deploy a reporting rule directly into a safety database such as Oracle Argus. System maintains all historical deployments information in different environments.
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.
Once a reporting rule is designed, it can be pushed to development, system test and Staging environments for testing. After testing is completed, it can be pushed to Production.
AUTOMATIC TEST SCRIPTS GENERATION
Once a user designs a Reporting Rule, GRRACE automatically generates a Test Script corresponding to the Reporting Rule. This captures the information to identify the test script as well as the verification step indicating the report that should be scheduled or generated once a case is locked.
GRRACE additionally allows a user to copy or manually create a test script and manage it within the system.
ADVANCED CONDITIONS LIBRARY
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.
GRRACE provides a user with an ability to view a color-coded report that compares the configuration in the system at a given date and time. The configuration parameters are compared between enterprises based on configuration and row values for easier identification.
GRRACE offers intricate dashboards based on cumulative summary counts and interim stages of approval for various components. Additionally the system provides for a timeline view that can be used to view the complete lifecycle and transition of a business requirement into a functional requirement to a reporting rule and eventually a test script offering insight for better control and effective planning.
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.