GMP Compliance Software for Manufacturers
Support GMP and cGMP compliance inside your ERP: lot and batch genealogy, QC hold states, versioned formulas, AQL inspections, and audit-ready records.
Good Manufacturing Practice (GMP) is the set of regulations that govern how products like drugs, food, dietary supplements, cosmetics, and medical devices are produced, controlled, and documented so they are consistently safe, pure, and effective. It matters because GMP failures (untraceable batches, uncontrolled processes, missing records) trigger recalls, FDA 483 observations, warning letters, and import bans, and the burden of proof falls on the manufacturer to show every lot was made to a defined, repeatable process. WorkCell supports GMP compliance by building lot and batch traceability, controlled BOMs and routings, QC hold states, and electronic records into the same ERP your shop floor runs against.
Sound Familiar?
Batch records reconstructed after the fact
Operators sign paper travelers, weigh-ups get logged on clipboards, and QC results sit in a separate spreadsheet, so the batch record for any given lot is assembled by hand days later and never quite reconciles with what actually happened on the floor.
Lot traceability gaps during a recall
When a raw material lot is flagged, you cannot pull every finished batch it touched in minutes, so the recall scope balloons, more product gets pulled than necessary, and the FDA wants genealogy you do not have at your fingertips.
Released product built to the wrong revision
Engineering updates a master formula or a routing while production keeps running the old one, and product ships built to a specification that is no longer the approved baseline, exactly the deviation a GMP audit is built to catch.
Quarantine and disposition handled on faith
Incoming material and in-process WIP sit in the same bins as released stock, hold and release decisions live in someone's memory or email, and there is no system enforcing that a lot under QC hold cannot be consumed or shipped.
Core Capabilities
Lot and batch genealogy
Every raw material lot tracks from receiving through each work order into the finished batch, so a single query returns full forward and backward genealogy: which incoming lots went into which batches, and which customers received them. Recall scoping that took days collapses to minutes.
QC hold and disposition control
Incoming material, in-process WIP, and finished lots move through explicit QC hold states with multi-location zones, so quarantined stock is physically and logically segregated and a lot on hold cannot be consumed or shipped until quality dispositions it.
Controlled formulas and routings
Multi-level versioned BOMs and routings with effective dating mean engineering change control is enforced by the system: work orders lock to the approved master formula and process revision in effect, so production never runs an outdated or unapproved baseline.
AQL inspection and deviation handling
AQL sampling templates and multi-type inspections capture incoming, in-process, and final QC against defined acceptance criteria, while NCR severity scoring and 8-D CAPA turn deviations and out-of-spec results into documented, closed-loop corrective actions with effectiveness checks.
Operation-level batch records
Hierarchical work orders with operator and terminal MES sign-offs capture who did what at each operation, with labor tickets, material consumption, and inspection results recorded against the order as it runs, so the electronic batch record is built in real time instead of reconstructed.
Audit-ready records and supplier quality
Approved supplier metrics, lot-level material evidence, and every inspection, NCR, and CAPA are queryable by lot, batch, supplier, or date range, so auditors pull objective evidence directly from the system instead of chasing paper across shared drives.
By The Numbers
The FDA current Good Manufacturing Practice regulations for finished pharmaceuticals that establish minimum requirements for methods, facilities, and controls
U.S. FDA, 21 CFR Parts 210 and 211
FDA warning letters and 483 observations issued each year, with inadequate records and lack of process control among the most cited cGMP deficiencies
U.S. FDA Inspection Observations
The FDA rule governing electronic records and electronic signatures that GMP manufacturers must satisfy when records are kept electronically
U.S. FDA, 21 CFR Part 11
Connected Modules
Quality
AQL inspections, NCRs, CAPAs, and QC hold dispositions live as first-class objects tied to the lots, batches, and work orders they govern.
Inventory
Lot and serial tracking with multi-location zones and quarantine states gives the segregation and genealogy GMP requires from receiving through ship.
Engineering
Versioned BOMs and routings with effective dating establish the approved master formulas and process baselines that work orders lock against at release.
Common Questions
What is GMP?
GMP, or Good Manufacturing Practice, is a system of regulations and quality controls that ensures products are consistently produced and controlled to the standards appropriate for their intended use. The current version enforced by the FDA in the United States is called cGMP (current Good Manufacturing Practice) and is codified primarily in 21 CFR Parts 210 and 211 for pharmaceuticals, with parallel parts covering food, dietary supplements, cosmetics, and medical devices.
Who has to comply with GMP?
Any company that manufactures, processes, packs, or holds drugs, biologics, medical devices, dietary supplements, cosmetics, or food for the U.S. market must comply with the relevant cGMP regulations enforced by the FDA. Contract manufacturers, repackagers, and many of their suppliers fall under the same requirements, and equivalent GMP regimes exist worldwide under bodies like the EMA and WHO.
What is the difference between GMP and cGMP?
GMP refers to Good Manufacturing Practice in general, while cGMP adds the word current to signal that manufacturers must use up-to-date systems, technologies, and controls rather than relying on practices that were acceptable years ago. In FDA usage the regulations are written as cGMP, and the agency expects companies to continuously improve their processes to stay current.
How does WorkCell support GMP compliance?
WorkCell is not itself GMP certified (GMP applies to manufacturers, not software), but its features directly support a manufacturer's compliance program. It provides end-to-end lot and batch genealogy, QC hold and quarantine states, versioned formulas and routings with effective dating, AQL inspections, NCR and CAPA workflows, and operation-level electronic records, all tied to the same parts, batches, and work orders the shop floor runs against.
What does GMP require for batch records and traceability?
GMP requires a complete, contemporaneous batch production record showing the materials, equipment, personnel, process steps, and quality results for each lot, plus full traceability from incoming raw material lots through finished batches to the customers who received them. WorkCell builds these records as work orders run and returns forward and backward lot genealogy on demand, so recall scoping and audit requests are answered in minutes.
How does a GMP audit or FDA inspection use ERP data?
An FDA investigator or third-party auditor samples lots and traces them end to end: incoming material certificates, QC hold and release decisions, the formula and routing revision in effect, operator sign-offs, in-process and final inspections, deviations, and CAPAs. WorkCell makes that evidence queryable by lot, batch, supplier, or date range, so you produce objective records on request instead of reconstructing them from paper and spreadsheets.
Does GMP require electronic records, and does WorkCell handle them?
GMP allows either paper or electronic records, but when records are electronic the FDA expects controls under 21 CFR Part 11 covering audit trails, access control, and signature integrity. WorkCell captures records electronically as production runs (operator sign-offs, inspections, dispositions), which gives manufacturers a contemporaneous record set to build their Part 11 controlled process on top of.
GMP Compliance Software for Manufacturers
Make every batch audit-ready before the inspector arrives.