LIFECYCLE STAGE: Release

Automate batch data aggregation and live review by exception of your manufacturing activities to decrease time to release

The Release Stage incorporates:

CPP and CQA management

Batch review automation

Product disposition

Use case #1: CPP and CQA Monitoring

Use case #2: Review by Exception

Use case #3: Batch Review and Approval

Release Stage use cases

Release STAGE: USE CASE #1

CPP and CQA Monitoring

Define and monitor CPPs and CQAs across the product lifecycle.

Define critical process parameters and quality attributes for systematic monitoring during execution.

Utilize in-batch monitoring to keep tabs on individual batch quality and post-batch trend analysis to ensure consistent quality and identify areas for process improvement.

R.O.I.

First-year savings for a site of 25 operators:*

Small molecule
$1,374,315

Large molecule
$3,319,469

Release STAGE: USE CASE #2

Review by Exception

Identify, review, and resolve process exceptions with real-time notifications and streamlined post-production workflows.

With one integrated system used by Manufacturing, Quality Assurance, and Quality Control, all teams can proactively monitor and intervene to prevent quality issues before they become exceptions with real-time notifications during production.

R.O.I.

First-year savings for a site of 25 operators:*

Small molecule
$791,665

Large molecule
$1,498,436

Release STAGE: USE CASE #3

Batch Review and Approval

Review aggregated exceptions, batch data, documents, and batch records for approval and release.

Automatically compile complete unit ops with essential data, sample test results, and incident reports without the legwork. Then easily review the comprehensive batch record from one system or conduct a streamlined review-by-exception process to approve and release batch records in a fraction of time.

R.O.I.

First-year savings for a site of 25 operators:*

Small molecule
$310,336

Large molecule
$232,752

*ROI calculation assumptions — Small Molecule: Number of batch runs = 500; Payroll burden = 50%; Tech transfers to other sites using Tempo: 1. Large Molecule: Number of batch runs = 50; Payroll burden = 50%; Tech transfers to other sites using Tempo: 3.