Biologics batch disposition and release records

Name: Biologics batch disposition and release records: per-batch genealogy, manufacturing parameters, testing/LIMS results, market-authorization status, hold and deviation events, and Qualified Person sign-off sequencing assembled across ERP, MES/EBR, LIMS, RIMS and QMS systems
Creator: AmpleLogic

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Biologics batch disposition and release records: per-batch genealogy, manufacturing parameters, testing/LIMS results, market-authorization status, hold and deviation events, and Qualified Person sign-off sequencing assembled across ERP, MES/EBR, LIMS, RIMS and QMS systems

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Coverage

Universe, instruments and categories.

Industry: Life Sciences Tools & ServicesApplication Software
Instruments: equities
Categories

Dataset card

Type: not stated
Format: Tabular
Volume: ~100K-500K batch release records per year plus millions of linked testing/audit-trail rows (est. across client biologics sites; each batch generates a checklist of dozens of connected data points)
Users: ~2,000-6,000 named enterprise seats (inferred from 330 vendor employees, ~$35M revenue range and multi-site pharma deployments with Qualified Person user groups)
History: 7 years
Update frequency: not stated
Growth: Active — current-generation product page with modern web stack and a portfolio of live GxP products; vendor headcount in the hundreds indicates ongoing delivery capacity
Launched: ~2019-2022 for BatchReleaseIQ (AmpleLogic itself founded ~2014 organisation record; the batch-release module is a later addition to an established MES/LIMS-adjacent portfolio)
Delivery: not stated
Entity mapping: not stated
Sample: not stated
Point-in-time: not stated
Licence: not stated

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