Module spotlight: Work Orders & Manufacturing Records
Production records are proof a product was built the way it was meant to be. Work orders and manufacturing records capture production as it happens.
By MoniDoseQMS Team
When a product is built, you need a record that it was built correctly — the right materials, the right steps, the right checks. Work orders drive production, and manufacturing records capture what actually happened, forming the production records regulators expect.
What you can do
- Issue and track work orders for production
- Capture manufacturing records as work is performed
- Tie records to batches, materials, and equipment
- Feed into product release with the evidence already assembled
Why it matters
Production and process controls under ISO 13485 §7.5.1, which the FDA QMSR incorporates, depend on contemporaneous production (batch) records. Capturing them in the system makes release decisions faster and recalls more precise.
See how MoniDoseQMS handles this
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