Case Studies

CASE STUDY

Safety/PV Aggregate Reports Automation

Project Profile

Project for a top 10 biopharmaceutical company looking to automate aggregate report planning, scheduling, report generation and submission tracking.

500 + products and a user base of 1000 + users worldwide.

8-month project implementation including data migration, validation (using customer validation methodology), training and post go live support activities.

Customer utilized multiple spreadsheets and e-mail exchanges for the aggregate reporting process.

Reconciliation and review of over 100+ spreadsheets using email or SharePoint as a repository.

Affiliates required to review global plan in each review cycle.

Manual re-conciliation and multiple points of data entry.

Customer had an audit finding with an undocumented decision made by an employee who was no longer with the company.

Current State

End-to-End aggregate reporting process from planning, scheduling, report generation and submission tracking.

One system for collaborative use by global planning group and all affiliates worldwide.

Reporting obligations (including EURD) worldwide automated based on product portfolio.

Optimize reporting plans utilizing harmonization strategies to reduce total overall reports.

Collaborate with other departments, partners and local affiliates.

Track decision log, review and approval history for complete traceability within the system.

Ability to track post submission PRAC/HA feedback.

Automated generation of aggregate reports.

Dashboards and reports with audit trail tracking all activities.

Key Benefits

Elimination of 100+ spreadsheets and associated reconciliation and review time.
80% automation and generation of world-wide reporting plans.
50% reduction in # of fields entered and re-use using automation.
50% reduction in # of fields entered and re-use using automation.
Alerts and auto error correction to minimize errors during planning and schedule creation.
Full traceability, decision log and audit trail of all activities, decisions made available within the system.
Improved compliance and consistency of information across signal, risk and aggregate reporting functions.
Fully automated reports and metrics for inspections and audits.
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