For Manufacturing and Quality Heads21 CFR Part 11, cGMP and GAMP 5: what an electronic batch record system enforces
How an electronic batch record system supports 21 CFR Part 11, EU GMP Annex 11, cGMP and data integrity, and a GAMP 5 approach to validation, and what stays the manufacturer's responsibility.
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For Manufacturing and Quality HeadsOne Approved BMR, Every Process Area
Extend one approved batch record to every process area of its block, and enforce each buyer's limits during the batch, always the stricter limit: fewer documents to write and review, and no drift between areas.
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For Manufacturing, Quality and IT HeadsAI Agents in Pharmaceutical Manufacturing
Answers from the batch record, in plain language, on the shop floor: what the agents answer, where the model runs, how they learn without seeing your records, and why they never become part of the record.
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For Plant, Quality and IT HeadsVendor Independence by Design
How complete product knowledge, open to every customer, lets pharmaceutical teams configure, run and validate their electronic batch records themselves, and get value from digitalisation at once.
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