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- ERP + Quality for Pharma
- Data model
The tables behind ERP + Quality for Pharma
ERP + Quality for Pharma ships with 12 tables, grouped here by the feature that uses them. Every record your team works with lives in one of them, and you can add fields and tables in Proto.
- Tables
- 12
- Features
- 6, plus shared settings
- Change it
- Add fields and tables in Proto
How the model is organised
Product and lot
Products provides the product identity; Batches records each manufacturing lot and its lifecycle.
Quality requirements and results
Quality specifications belongs to a product. Test results belongs to a batch and can reference a specification.
Exceptions and changes
Deviations belongs to a batch and can reference Equipment; capa actions can reference a deviation. Change controls can reference a product or supplier.
Release evidence
Release decisions belongs to a batch and can reference its product. Operation receipts can reference the batch whose operation was performed.
Reference data
Equipment and Suppliers hold current readiness and qualification information. Users holds account records.
Every table, by feature
- Batches and products2
- Specifications and testing4
- Deviations and CAPA4
- Change controls4
- Equipment and suppliers4
- Release decisions6
- Shared and settings1
- Products
Marketed and investigational pharmaceutical products with dosage form and strength.
- Batches
Manufacturing batches with lot numbers, quantities and batch lifecycle status.
Linked to Products
- Products
Marketed and investigational pharmaceutical products with dosage form and strength.
- Quality specifications
Quality specifications defining required tests and acceptance limits per product.
Linked to Products - Test results
Test results recorded against a specification and batch, with pass or fail outcome.
Linked to Batches, Quality specifications - Batches
Manufacturing batches with lot numbers, quantities and batch lifecycle status.
Linked to Products
- Deviations
Planned and unplanned deviations raised during manufacturing or testing.
Linked to Batches, Equipment - Capa actions
Corrective and preventive actions opened to close quality issues.
Linked to Deviations - Batches
Manufacturing batches with lot numbers, quantities and batch lifecycle status.
Linked to Products - Equipment
Production and laboratory equipment with calibration and qualification status.
- Change controls
Controlled changes to process, specification or supplier with impact assessment.
Linked to Products, Suppliers - Products
Marketed and investigational pharmaceutical products with dosage form and strength.
- Suppliers
Qualified suppliers of active ingredients, excipients and packaging components.
- Batches
Manufacturing batches with lot numbers, quantities and batch lifecycle status.
Linked to Products
- Equipment
Production and laboratory equipment with calibration and qualification status.
- Suppliers
Qualified suppliers of active ingredients, excipients and packaging components.
- Deviations
Planned and unplanned deviations raised during manufacturing or testing.
Linked to Batches, Equipment - Change controls
Controlled changes to process, specification or supplier with impact assessment.
Linked to Products, Suppliers
- Release decisions
Independent quality review and release decisions for each batch.
Linked to Batches, Products - Batches
Manufacturing batches with lot numbers, quantities and batch lifecycle status.
Linked to Products - Operation receipts
Evidence ledger of quality operations performed, with outcome and evidence link.
Linked to Batches - Test results
Test results recorded against a specification and batch, with pass or fail outcome.
Linked to Batches, Quality specifications - Deviations
Planned and unplanned deviations raised during manufacturing or testing.
Linked to Batches, Equipment - Capa actions
Corrective and preventive actions opened to close quality issues.
Linked to Deviations
Keys and references
Batch number identifies the manufacturing lot, while the Product reference links it to a product. Deviation number, capa number, change number, decision code and receipt number identify their own records. The links between them should be checked during import: a matching text label is not the same as a reference to the correct record.
Migration order
- Enter Products, Equipment and Suppliers.
- Enter quality specifications against the intended Products.
- Enter Batches against Products.
- Enter test results, Deviations and change controls with their references.
- Enter capa actions against the corresponding Deviations.
- Enter release decisions and operation receipts against the appropriate Batches.
Set up ERP + Quality for Pharma your way.
Start free, then use Proto to change fields, steps and approvals before your team goes live.