21 CFR Part 11
Electronic records & signatures
Signatures re-authenticate the user and are bound to the record; idle timeout, password policy and two-factor sign-in for administrators.
Corpex-ERP · Pharma-ERP
The ERP that runs on batches, not just invoices.
Corpex-ERP is pharmaceutical ERP software for GMP manufacturers: planning, purchasing, warehouse, production, quality, sales, costing, finance and maintenance on one batch record, with lot genealogy built as the batch moves and an audit trail made for inspection.
- Stage 1Planned
- Stage 2Dispensing
- Stage 3In production
- Stage 4Packaging
- Stage 5Awaiting QC
- Stage 6Released
Every batch walks the same six stages. Release signs and locks the batch record.
- 10
- ModulesPlanning to HR
- 6
- Batch stagesPlanned to released
- 2
- LanguagesArabic and English
- 1
- Batch recordShared by every department
End to End
From Forecast to Ledger, One Thread
Each step hands the same lot and batch to the next module, so a number entered once is the number every department reads.
- ForecastPlanning
- PurchasePurchasing
- ReceiveWarehouse
- Test & acceptQuality
- DispenseManufacture
- Produce & packManufacture
- ReleaseQuality
- Ship & invoiceSales
- Cost & postCosting · Finance
The Modules
Ten Modules, Shown in the Real Application
Pick a module to see its screen. Every screenshot is taken from Corpex-ERP running on demo data.
01 / 10
Planning
Turn demand into a schedule the plant can actually run.
- Forecast planning per product and pack, with approval
- Planned vs made batches by week
- Kitting lists for every product before dispensing
- Upcoming plan items and forecasts by status
02 / 10
Purchasing
From requisition to received goods, with every approval on record.
- Purchase requisitions with approval routing
- RFQs, purchase orders and supplies follow-up
- Supplier performance: on-time delivery, QC rejection rate, lead time
- Purchasing reports, shipping addresses and carriers
03 / 10
Warehouse
Every lot knows its QC status, expiry and store.
- Material receiving, withdrawal, transfers and returns
- Lots by state: issuable, in quarantine, return or write-off
- Expired materials, shortage and reorder proposals
- Consumption by department and total stock reports
04 / 10
Manufacture
The batch record is the centre of the system.
- Production schedule for dispensing and packaging
- Dispensing refuses lots that are not released or have expired
- Batch record with stages, yield, disposition and PDF
- Traceability workbench and signed recall records
05 / 10
Quality
QC decides what moves, and the system enforces it.
- Specifications and products in a QC view
- Samples, material acceptance and batch release
- Quality events, lab reports and analyst workload
- Reagent containers and analyst qualifications
06 / 10
Sales
Know which customer received which batch, every time.
- Quotations, sales orders with approvals and invoices
- Customer and market price lists with validity dates
- Shipments, carriers and inbound freight
- Batch-to-customer lookup for recalls
07 / 10
Costing
What each batch really cost, against what it should have.
- Manufacturing cost estimates per product
- Actual batch costing: material, direct labour, indirect, depreciation
- Cost variance against the approved standard
- Costing dashboard and batches above standard
08 / 10
Finance
A general ledger fed by the operations that created the numbers.
- Chart of accounts, journal vouchers and entries
- Receivables, payables, supplier invoices and payments
- Posting periods that lock, cost centres, balance sheet
- Multi-currency with exchange-rate revaluation
09 / 10
Maintenance
Keep equipment qualified before it touches a batch.
- Assets, infrastructure and spare parts
- Maintenance requests, engineering plans and planned work due
- Calibration and qualification register
- Maintenance KPIs and breakdown trends
10 / 10
HR
People, positions and training records in the same system.
- Organization: departments, positions and org chart
- Attendance sheets and leave requests with approval
- Training management: topics, instructors, due trainings
- HR reports
Batch and Lot Traceability
One search from a lot to every customer who received it
Regulators expect a manufacturer to trace any batch backward to its raw material lots and forward to every customer, fast enough to act on a recall. In Corpex-ERP that genealogy is built as the batch moves, not reconstructed afterwards from spreadsheets.
- Search by material lot, supplier lot or batch number.
- Batches, finished goods received, packs shipped and packs still in stock, in one view.
- A recall simulation lists the customers to notify, with quantities and invoices.
Recalls
A recall is a record, not a phone list
Each recall carries its class, reason and scope, then moves through opened, scope frozen, customers notified and closed, with QA signing the steps. Returned and destroyed quantities give you recall effectiveness as a number, ready for the inspector.
- Scope frozen from the traceability result.
- Customers notified, by channel and time.
- Batches held, packs returned, effectiveness calculated.
Maintenance
Calibration and qualification in the same system
Tablet presses, dryers, HVAC units and laboratory instruments sit in one register with their location, next due date and latest state, so overdue or failed equipment is visible before it touches a batch.
Inspection Ready
What an Inspector Checks in a Recall Simulation
Can you trace backward fast?
From a finished batch to every raw material lot that went into it, without opening a spreadsheet.
Can you trace forward completely?
From a batch to every customer, invoice and pack quantity, including samples that left the site.
Was released stock really released?
Lot status and QC approval sit on the record, and a released batch record is signed and locked.
Who did what, and when?
Every step carries the user and the time, with electronic signatures where the decision matters.
Global Compliance
Built Around the GMP Rules Inspectors Apply
The technical controls in Corpex-ERP map to the regulations below. Each card names the control that answers it.
EU GMP Annex 11
Computerised systems
Role-based access, a time-stamped audit trail on each record, entry checks such as blocked negative stock, and posting periods that lock.
21 CFR Part 211
Current GMP for finished pharmaceuticals
Batch production records (211.188) and distribution records (211.196) that let a recall reach every customer who received a batch.
EU GMP Chapters 4 & 5
Documentation and production
A batch record built as the batch moves, and dispensing that refuses any material lot not released or past expiry.
EU GMP Annex 15
Qualification and validation
A calibration and qualification register for every quality-impact asset, with next-due dates and overdue or failed states.
EU GMP Annex 16
Batch certification and release
Batch release is a signed QC step; once released, the batch record is locked.
EU GMP Annex 19
Reference and retention samples
Retained samples are recorded in each batch's disposition and kept in a retained-samples register.
ICH Q7
GMP for active pharmaceutical ingredients
Lot genealogy, material status and release controls that apply to API production as well as finished dosage forms.
ALCOA+ · PIC/S PI 041
Data integrity
Every entry is attributable to a user and a time, released records are locked rather than overwritten, and corrections leave a trail.
GAMP 5
Risk-based validation
Validated by the Corpex team with a risk-based approach and IQ, OQ and PQ documentation; see CSV services.
Designed to the expectations of
- US FDAUnited States
- EMAEuropean Union
- MHRAUnited Kingdom
- PIC/SInspection co-operation scheme
- WHOWorld Health Organization
- ICHHarmonised guidelines
Compliance belongs to the validated system and the procedures around it. Corpex-ERP supplies the technical controls, and the Corpex validation team documents them for your inspection.
Pharma-ERP
Pharma-ERP for GMP Manufacturers, Wherever You Make Medicine
A general-purpose ERP treats a batch as an inventory line. Corpex-ERP treats it as a regulated record, which is what EU GMP, US FDA and WHO inspectors look for. It works alongside CORPEX-eQMS and CORPEX LIMS, and is validated like any other GxP computerized system through computer system validation (CSV).
Your servers or private cloud
Installed on-premise or in your own cloud tenancy, so batch and financial data stay under your control.
Multi-language, multi-currency
Arabic and English on every screen, and multi-currency finance with exchange-rate revaluation.
Implemented with you
Configuration, data migration, training and validation delivered by the Corpex team, then supported after go-live.
See a Batch Go From Plan to Release
Book a demo and we will walk one batch through dispensing, production, QC release and a recall simulation with you.
Request a DemoFrequently Asked Questions About Pharmaceutical ERP
What is pharmaceutical ERP software?
Pharmaceutical ERP is software designed to manage all business processes — finance, HR, supply chain, manufacturing, and quality — while maintaining GMP compliance and regulatory traceability required by FDA and other authorities.
How does CORPEX-ERP differ from SAP or Oracle?
CORPEX-ERP is purpose-built for regulated industries with out-of-the-box GMP compliance, FDA 21 CFR Part 11 support, and native LIMS/QMS integration, so GMP-specific needs are covered without the custom development a general-purpose ERP may require.
How does batch and lot traceability work in CORPEX-ERP?
Every raw material, intermediate and finished-goods lot carries a genealogy record in CORPEX-ERP: which raw material lots went into which batch, which batches went into which finished-goods lot, and where each finished lot shipped. That genealogy is what makes a forward-and-backward recall trace possible in minutes rather than days of manual document review.
Can ERP integrate with quality management and LIMS?
Yes. CORPEX-ERP natively integrates with CORPEX-eQMS and LIMS, providing end-to-end visibility from raw material procurement through manufacturing, quality control, and distribution.
Does CORPEX-ERP support GMP quality holds on inventory?
CORPEX-ERP's production planning and inventory control modules work alongside CORPEX-eQMS so that a lot under an open deviation or awaiting QC disposition is held from release or shipment until quality closes it out — inventory status and quality status stay in step.