Global Reporting Rule and Audit Capture Engine (GRRACE) solution automated the process of creating new reporting rules or modifying existing ones in Argus Safety at a top tier Pharmaceutical Company
Overview
Nextrove has been supporting one of the world’s premier biopharmaceutical companies to automate, simplify and optimize the end-to-end development of Argus Safety reporting. Nextrove’s GRRACE (Global Reporting Rule and Audit Capture Engine) application has been leverage for the project.
The Goal
Creation and maintenance of Argus Safety reporting rules to auto-schedule reports for submissions to multiple destinations includes several steps and multiple stakeholders:
Reporting rules are a critical component of Argus Safety configuration to ensure compliance with regulations. Each step requires approval by respective stakeholders and extensive QC. Additionally, the cycle re-start to incorporate in reporting rule any new regulatory change including tracking of the relevant maintenance activities to demonstrate compliance with the effective date of regulations.
The manual end-to end process includes a series of hand-offs, paper-based configuration design, archive maintenance to document the entire cycle from requirements to testing, from QCs to approvals and to deployment.
Objective of project was to automate the entire end-to-end process, to track all actions, to keep records of approvals, to support inspections readiness via an application audit-ready, and to maintain and monitor metrics.
The Approach
Nextrove GRRACE application includes a workflow with various steps, and it is audit ready.
The process starts with entry of regulatory requirements by the business department(s). Upon approval, the second step includes the automatic transposition of requirements,
based on defined and configured rules, into a screen mimicking the fields of Argus console. An Advance Condition (AC) Library is available to select the appropriate AC. Following approval of the reporting rule design, the reporting rules script designer supports the preparation of test scripts. Upon approval of test script, testing is performed, and results embedded and archived in the application. Deployment in Argus Safety and in multiple environments happens automatically and Argus Safety console is automatically populated, following approval of test results.
The Benefits
Nextrove GRRACE automates the process of creating new reporting rules or modifying existing reporting rules in Argus Safety.
Nextrove GRRACE provides one single repository for activities, approvals and documentation supporting the creation of reporting rules and increases efficiencies by eliminating manual hand-offs.
Additionally, by automating key stages from requirement to deployment, it significantly reduces operational costs and time.
From a quality perspective, Nextrove GRRACE ensures transparency for end-to-end process and facilitates inspection readiness by incorporating the audit trail and providing a dashboard to generate reports and collect metrics.
Client Testimonials
Nextrove Team showed consistency, passion and Knowledge and contributed at the highest level for the go-live accomplishment. They are all resources I would like to work with in upcoming activities