Pharmaceutical Manufacturing
Capture the batch record where the work happens, so review is reading a finished record instead of chasing twelve missing initials.
Under 21 CFR 211.188 a batch production and control record has to be prepared for every batch, with complete information on how that batch was produced and controlled. Under 211.100(b) each significant step gets documented at the time it is performed, not reconstructed later. Under 211.192 the quality control unit reviews and approves all of it before the batch is released, and any unexplained discrepancy gets investigated whether or not the product already shipped. WorkCell is built so that record accumulates as the work happens. Operators record quantities, yields, scrap, and in-process results at the operation; every material issue keeps its lot link; versioned bills of material and routings carry the revision the batch was actually run to. The same database schedules the plant against real capacity, so a hold waiting on a release test reshuffles the plan rather than silently eating a shipment.
Contract packagers, nutraceutical and OTC manufacturers, combination-product and drug-device assemblers, and the component, container, and closure suppliers running lot-controlled batch work under a drug manufacturer's cGMP flow-downs.
| Standard | What It Requires |
|---|---|
| GMP | Current good manufacturing practice under 21 CFR Parts 210 and 211 requires a batch production and control record per batch, documentation of each significant step at the time it is performed, quality control unit review before release, and investigation of every unexplained discrepancy. |
| 21 CFR Part 11 | An electronic record standing in for a paper one must be attributable to a person, time-stamped, retrievable through the retention period, and protected so that a change cannot go undetected. Which systems fall in scope is decided by your own risk assessment, not by a vendor. |
| ISO 9001 | The general quality management foundation, covering corrective action, internal audit, management review, and control of nonconforming product alongside the cGMP requirements. |
| ISO 13485 | Applies where the product is a combination product or a drug-device assembly, adding device-side traceability and production record requirements on top of cGMP. |
Each receipt carries its own lot, its certificate of analysis, and its inspection disposition, and material that has not passed stays in a hold state the system enforces rather than a quarantine tag on a tote. Every issue to a batch preserves the lot link, and completions assign the batch number that goes on the label. One batch number resolves backward to every API, excipient, container, and closure lot that went into it, the operator who ran each step, the in-process results recorded against it, and the formulation and process revision in effect that day. Forward trace runs the other way, from a suspect incoming lot to every batch and every shipment it reached, which is the question a recall decision turns on and the question 211.192 forces when a discrepancy is found after distribution.
Quantities, yields, material lots issued, equipment and work centre used, in-process results, and the operator and timestamp on each step, accumulated from the work the floor actually did.
Generated from the batch record, tying the released quantity to its lots, its test results, and the acceptance activities that closed out.
Backward trace from a batch to every input lot and forward trace from an input lot to every batch and shipment it reached, with issued against produced quantities reconciled.
Severity-classified nonconformances with disposition and containment, escalated into an 8-D corrective action when a discrepancy turns out to be systemic rather than a one-off.
Sampling plans, the characteristics checked, the results captured at the step, and the hold or release decision each one drove.
The quality control unit cannot release until the record is complete, and the record arrives incomplete: a missing initial, a blank yield, a correction without a reason, a weight recorded on a scrap of paper and copied over later. Every one of those goes back to the floor as a query, and the batch sits on hold while the paperwork catches up to the product.
The regulation says document each significant step when you perform it. The reality on a paper batch record is an operator finishing a run and then filling in the sheet, which is exactly the pattern an investigator looks for and exactly what data integrity expectations are written to prevent. The fix is capture at the step, not another training session.
The ERP knows what was consumed in total, so somebody maintains lot-level links and mass balance by hand in a spreadsheet they own personally. It works until a discrepancy surfaces after distribution, when the investigation has to extend to other batches and the only trace evidence is one person's workbook.
Deviations and CAPAs live in a quality application, batches live in the ERP, and the link between them is a reference number typed into a free-text field. Nobody can answer which batches a recurring deviation touched without reading both systems side by side and hoping the numbers were typed correctly.
A spreadsheet plan assumes release testing comes back in three days and the packaging line is free when the batch clears. Neither assumption survives a retest. Without finite capacity scheduling, one held batch quietly pushes everything behind it and the customer finds out before the planner does.
Batch data captured at the step, not after it
Operators clock on to an operation and record quantities, yields, scrap, and in-process results at the point of work. Each entry carries the person and the timestamp, which is what makes a record attributable and contemporaneous rather than reconstructed.
Lot genealogy from input material to packaged batch
Receiving records the lot and its certificate, issues to a batch preserve the link, and completion assigns the batch number. Forward and backward trace resolve from one identifier, with mass balance falling out of the same transactions.
Enforced hold and release states
Material awaiting incoming inspection or release testing sits in a hold state the system respects, so it cannot be issued to a batch because the line was waiting. The disposition is a state in the data, not a tag on a pallet.
AQL sampling plans and inspection templates
Sampling plans and templates define what gets checked at receiving, in process, and at finish, and the results are recorded against the characteristic rather than summarised as a pass. The sampling basis for a decision stays visible years later.
Deviations and 8-D corrective action against the batch
A failed check raises a severity-classified nonconformance against the batch, the lot, and the item that produced it, and a systemic cause escalates into an 8-D corrective action. Extending an investigation to other batches becomes a query instead of a reading exercise.
Finite capacity scheduling around release testing
The scheduler plans against real equipment and labour capacity, and proposal runs let a planner test a sequence before committing it. When a batch is held for a retest, you see which downstream shipments move before you promise a date.
Lot traceability from receiving to shipment, with enforced hold and release states.
ProductionFinite capacity scheduling and operator terminals that capture batch data at the step.
QualityAQL sampling, in-process results, severity-classified deviations, and 8-D corrective action.
EngineeringVersioned formulations and routings carrying the revision a batch was actually run to.
Purchasing, inventory, scheduling, production, quality, and job costing on one database.
MESOperator terminals capturing quantities, yields, and in-process results at the step.
QMSInspections, deviations, and 8-D corrective action tied to the batch that produced them.
APSFinite capacity scheduling that accounts for release testing and equipment changeover.
What cGMP asks of production records and which of them WorkCell keeps.
21 CFR Part 11What an electronic record has to prove, and where the line between software and your validation sits.
Medical DevicesComparable record depth under ISO 13485 and the Device History Record.
Chemical ManufacturingLot-controlled batch work with certificates of analysis and substance declarations.
What is pharmaceutical manufacturing software?
Pharmaceutical manufacturing software runs purchasing, inventory, scheduling, production, and quality on one database, keeping the batch production and control data, lot genealogy, and deviation records cGMP requires. The difference from general ERP is that the batch record and the lot trace are first-class rather than reporting afterthoughts.
Is WorkCell 21 CFR Part 11 compliant?
No vendor can hand you Part 11 compliance, because it covers your procedures, your access controls, and your validation as well as the software. WorkCell records who performed each transaction and when, keeps records retrievable, and enforces role-based access. Document control and approved electronic signatures are not features we claim today.
Can WorkCell replace our paper batch record?
WorkCell captures the production and control data a batch record is built from, at the step, with the operator and timestamp on each entry. It is not a validated electronic batch record system with approved electronic signatures, so treat it as the system of record for production data, not as a drop-in for an executed master batch record.
How does WorkCell shorten batch record review?
Review slows down because the record arrives incomplete. Capturing quantities, yields, and in-process results at the operation removes the missing-initial and blank-field queries that bounce back to the floor, and the lot genealogy and mass balance are already reconciled rather than assembled by hand for the reviewer.
Does WorkCell handle DSCSA serialization?
Not directly. WorkCell holds the lot, batch, and serial records and the expiration and manufacture dates behind a product identifier, and a REST API and webhooks let those records reach a serialization or EPCIS repository provider. Generating and exchanging DSCSA transaction data stays with that provider.
Is WorkCell a fit for a small pharma or contract packaging operation?
It fits discrete and mixed-mode plants from roughly ten to a thousand employees running lot-controlled batch work: packaging, assembly, filling, nutraceutical and OTC production. Continuous process chemistry with recipe scaling and tank-level material balance is not what this system is built around.
See it run on your parts.
Tell us how your batch records get built and reviewed today and we will tell you straight whether WorkCell is a fit.