Reporting and Analytics

The true power of the Electronic Batch Record (EBR) system is not just in accumulating the records, but in transforming them into a ready-to-present report, a ready-to-show report, and a continuously-improvement-ready analysis. The Reporting and Analytics module integrates the production steps, quality inspection, corrective action process, audit trail, environmental conditions report, and serialization/Prescription Tracking System notifications into a single logical flow.

With this, you can generate a complete batch file starting from a ‘core batch record’ for a single batch, all the way to a comprehensive batch file including deviation reports, corrective action plans, audit trail summaries, environmental conditions reports, and serialization notifications. This approach reduces the burden of manual record searching in auditing; speeds up quality inspections, and provides production managers with a clear view of process performance.

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Reporting and Analytics

Reporting and Analytics manages a batch-based report library, creates packaged output sets such as the Batch Quality File, reports audit trail and electronic signature records, makes the relationships among deviations, corrective actions and changes visible, and links integration reports such as…

Reporting Library

Serial Quality File

Batch Review Package

Trend and Gauge Panels

Traceability and Validation Chain

Data Transfer and Archiving

Reporting Library

The user selects the report from a ‘ready template’ based on their needs: core batch record, deviation report, corrective action report, audit trail report, environmental conditions report, serialization report, etc. Thus, reports are tailored to the user; a standard report language is formed.

Features

Batch-specific report templates
Role-based report access
Filtering and quick searching
Report metadata and version tracking

Batch-specific report templates
The core batch record, deviation report, corrective action report, audit trail report, environmental conditions report, and serialization report are produced in standard formats.

Role-based report access
It provides the right report to the right role with the right scope.

Filtering and quick searching
It allows quick access to the report based on product, site, batch number, date range, and other criteria.

Report metadata and version tracking
The date the report was generated, the system/service that created it, and its version are visible on the report.

Serial Quality File

To present a single batch under a ‘single folder’ logic, the module integrates all the core and additional packages associated with the batch.

Features

The main navigation page
Package-based content blocks
Regulatory references and scope
Batch file usage guide

The main navigation page
It generates a master navigator that lists all the packages associated with the batch and directs users to the relevant reports.

Package-based content blocks
By segmenting the deviation, corrective action, audit trail, environmental conditions, and serialization packages, readability is improved.

Regulatory references and scope
It clearly indicates which regulations and standards the document is evaluated against.

Batch file usage guide
It provides a practical and guiding inspection route for inspectors.

Batch Review Package

It consolidates the required evidence set for quality inspection into a single ‘review package’; all the records supporting the decision are visible in the same context.

Features

The scope of the review and the control list
The links between deviations, corrective actions, changes, and other entities
Electronic signature manifest
Summary of batch release decision

The scope of the review and the control list
It standardizes which record sets are considered.

The links between deviations, corrective actions, changes, and other entities
It clearly shows the chain of cause and effect between events.

Electronic signature manifest
It summarizes all critical signatures in a single table for quick verification.

Summary of batch release decision
It summarizes the date, signature, and previous controls of the decision.

Trend and Gauge Panels

Highlights improvements and risk signals at an early stage through visible views of batch designs.

Features

Parameter and Time Trend Analysis
Exception and Deviation Intensity Indicators
Correction Activity Tracking
Environmental Condition Trends

Parameter and Time Trend Analysis
Real vs. Target Comparison Over Time

Exception and Deviation Intensity Indicators
Prioritizes repeatable risk areas.

Correction Activity Tracking
Ensures actions are truly effective.

Environmental Condition Trends
Summarizes temperature, humidity, and pressure data within the batch context.

Traceability and Validation Chain

Provides a clear audit trail for the question 'Which validation does this decision rely on?'

Features

Audit Trail Summary Report
Visible Control of Scrap / Retain
Environmental Conditions and Serialization Evidence
Validation-Decision Association

Audit Trail Summary Report
Details who, what, when changes are made.

Visible Control of Scrap / Retain
Translates manipulation risks into the control language.

Environmental Conditions and Serialization Evidence
Bundles optional packages for batch suitability.

Validation-Decision Association
Visible context of the batch release decision.

Data Transfer and Archiving

Standardized data transfer and archiving approach for secure storage and quick retrieval of reports.

Features

Standard Output Package Production
Archiving and Retention Management
Authorized Access and Sharing
Visible Control Notations for Printed Copies

Standard Output Package Production
Combines multiple reports into a single, ready-to-use package.

Archiving and Retention Management
Visible Approach to Storing Electronic Records

Authorized Access and Sharing
Ensures reports are accessible only to authorized users.

Visible Control Notations for Printed Copies
Explicitly states that printed copies are not controlled.