Pharmaceutical

Dispensing to QA release, with every signature where it belongs.

A solid-dose plant lives by its batch record. VECHR MES enforces it at each step, so the record is complete the moment the batch ends.

In short

Only released material can be consumed. Weighing needs a second person's signature. IPC values come from the tester. Signatures are re-authenticated and hash-chained, built on 21 CFR Part 11 principles.

Worked example: 360 kg of blend becomes 600,000 tablets, then 5,900 boxes on 4 pallets.

360 kg of final blend
600,000 tablets compressed
5,900 boxes on 4 pallets, released by two signatures

Product: Paracetamol 500 mg film-coated tablet, box of 10 × 10 (fictional)
Bulk order: 600,000 tablets, 370.8 kg, one batch number for bulk and pack
Pack order: 6,000 boxes, 5,900 packed on 4 pallets, 28 boxes to QC (Quality Control) samples
Yield: Bulk 99.1 %, packing 98.3 %
Machines: Scales, granulator, dryer, tablet press and tester, coater, blister lines, checkweigher

SAP owns stock and material status. VECHR MES consumes only lots SAP QM has released, posts receipts into quality-inspection stock, and gets the released bulk back as stock for packing.

Nine stages, one batch record.

From the dispensing booth to QA (Quality Assurance) release. Scroll to follow the batch.

01 kg

Dispensing VECHR MES records Released lots only. Weighed by and verified by.
02 batch

Granulation and drying VECHR MES records End point and LOD from the PLC
03 batch

Final blend VECHR MES records Lubrication time
04 tablets

Compression VECHR MES records IPC every 30 minutes: weight, hardness
05 tablets

Film coating VECHR MES records Bed temperature and weight gain
06 bulk lot

Bulk hold and QC VECHR MES records Validated hold time enforced
Bulk becomes packs
07 blisters

Primary packing VECHR MES records Line clearance, coder text read back
08 boxes · pallets

Secondary packing VECHR MES records SSCC per pallet
09 batch

QA release VECHR MES records Record review, two-person signature

Who decides what, and where it shows up.

Record	Owned by	What the other side does
Incoming material released, rejected or due for retest	SAP QM	Stock status in VECHR MES, enforced at dispensing
Bulk released for packing	SAP QM	Released bulk stock sent to VECHR MES
Batch held on the floor	VECHR MES	Block in SAP, if already received
Finished goods released	VECHR MES, two signatures	Usage decision in SAP
Lab results and deviations	LIMS and QMS	Results into the batch record, deviations raised on the floor

Released material, a second person's signature and machine-read IPC, enforced at each step.

Today The second checker signs a paper sheet later.

With VECHR MES Weighed by and Verified by sign at the step, from their own logins.

Today IPC (In-Process Control) values are written down every 30 minutes.

With VECHR MES Values come from the tester and press, locked, with limits enforced.

Today A quarantined lot slips into dispensing.

With VECHR MES Only unrestricted lots can be consumed. Everything else is refused.

Today The batch record is assembled after the batch.

With VECHR MES It is complete when the batch ends, ready for review.

How to read the status: Ready runs on the standard product. Configured is assembled in your project from existing building blocks, without new code. Built on request is developed once discovery confirms the need.

Stage	How VECHR MES handles it	Status
Material status	Expired lots and anything not released are refused. FEFO (First Expired, First Out), with a stored reason for an override.	Ready
Dispensing	Tare and gross from the scale, weighing lock, wrong material refused. The tolerance band is shown.	Ready Configured in your project
Second-person check	Weighed by and Verified by, different signers, password re-entry. The step cannot finish until both sign.	Ready
IPC	Limits enforced by the system, one record per 30-minute check, values read from the tester and press and locked.	Ready
Out of limits	Refused, or accepted only with a reason and an automatic non-conformance.	Ready Configured in your project
Deviations	Code, severity and lifecycle to disposition. A critical deviation holds the batch.	Ready
Bulk hold time	The validated hold time is enforced. The lot is refused after it.	Ready
Equipment status	A machine awaiting cleaning cannot take the next batch.	Configured in your project
Operator qualification	Certifications with expiry, checked before a step starts.	Configured in your project
Line clearance	Work instruction with required steps, acknowledgements, operator and QA signatures, before blistering.	Ready
Packaging	Coder text sent and read back, rejects by cause, QC samples, pallets with GS1 SSCC (Serial Shipping Container Code).	Ready

Seven checks between the dispensing booth and release.

Each one sits on the step it protects, with the signature it needs.

21 CFR Part 11 principles, built into how records are made.

Password re-entered at every signature, failures logged
Name, date, time and meaning shown on screen and in the PDF
A SHA-256 hash chain per order, checked with Verify Integrity
An append-only audit trail with old and new values
Account lockout, password expiry and a system access log
Line clearance as a signed work instruction before packing

21 CFR Part 11 and Annex 11, control by control.

Control	How VECHR MES handles it	Status
Signature components (§11.200)	Logged-in user plus password re-entered at every signature, failures logged	Ready
Manifestation (§11.50)	Name, date and time, meaning, on screen and in the PDF	Ready
Linking (§11.70)	Bound to order, unit and step, SHA-256 chain per order, Verify Integrity	Ready
Sequencing and authority (§11.10 f, g)	Routing sequence, signature slot order, role per slot, different-signer rule	Ready
Audit trail (§11.10 e)	Master data with old and new values. Transactions append-only, corrections as new records.	Ready
Access (§11.10 d, §11.300)	Password complexity and expiry, lockout, idle timeout, system access log	Ready
User IDs never reused (§11.100 a)	Unique among active users. Disable, do not delete.	Configured in your project
Reason for change, approval of revisions (Annex 11 §9)	Not built yet	Built on request
Validation (§11.10 a)	Functional and configuration specs, traceability, IQ and OQ scripts as a services deliverable	Built on request

Machine values arrive in the batch record without typing.

The Edge Agent reads the equipment and keeps recording if the network drops.

Machine signal	What happens in VECHR MES	Status
Granulator end point, dryer and coater temperatures	Values in the batch record, locked	Ready
Tablet tester result	A new IPC record every 30 minutes	Configured in your project
Press force out of band	Non-conformance raised and batch held	Configured in your project
Machine run, stop, fault	Downtime record, with the reason added by the operator	Configured in your project
Batch starts at the blister line	Batch and expiry written to the coders, read back	Configured in your project
Batch leaves a machine	Machine set to awaiting cleaning	Configured in your project

The press is the bottleneck. Drum-Buffer-Rope paces the schedule to it, and OEE (Overall Equipment Effectiveness) shows where its time went.

From the API lot to the delivery, in both directions.

The batch record PDF carries every consumption, signature, IPC value, non-conformance and pallet, with an integrity hash.

A recall, step by step.

1 Block the suspect lot SAP QM blocks it, and dispensing refuses it at once.
2 Find bulk, then FG batches One level per query, in VECHR MES.
3 Hold and block Holds in production, finished stock blocked in SAP.
4 Pallets to deliveries SSCCs lead to the deliveries in SAP.
5 Link it to the QMS One non-conformance per batch, linked to the recall.

Real cases this answers: the 2019 ranitidine withdrawal and the 2022 contaminated-solvent syrup cases, both about raw-material source and quality.

The tablet press sets the pace.

Cleaning sits inside the plan, not after it.

Drum The bottleneck that limits the whole plant. VECHR MES detects it automatically from the load.
Buffer How many minutes earlier the steps before the drum start, so it never waits.
Rope The release rule: upstream work starts at drum free minus buffer. Steps after the drum run forward.

Illustrative timing: the operations before the bottleneck take 45 minutes, and the bottleneck is free at 10:00.

Need	How it is handled
Bottleneck pacing	Drum-Buffer-Rope paces granulation and blending to the press
Cleaning between batches	Cleaning time on the resource schedule, and machines blocked while awaiting cleaning
Bulk hold	Validated hold time enforced on the bulk lot
Changeovers	A changeover matrix per resource, from product to product
Capacity	Shifts, calendars, breakdowns and certified crews

The scheduler adds changeover time for the sequence it builds. Campaign sequencing stays with the planner.

SAP QM decides lot status. VECHR MES enforces it on the floor.

Lot status from SAP controls what can be consumed. Movements and usage decisions go back.

About 25 postings a batch. The effort is in the QM decisions, not the volume.

SAP movement	Posted when	Status
Goods issue (261) at dispensing	Each dispensed lot is consumed	Configured in your project
Bulk goods receipt (101) into quality stock	Bulk leaves the last process step, opening the QM inspection lot	Configured in your project
Released bulk back to packing	SAP QM releases the bulk and stages it	Configured in your project
Goods issue (261) at packing	Foil, PVC (Polyvinyl Chloride), leaflets and boxes are consumed	Configured in your project
FG goods receipt (101) into quality stock	A pallet is closed	Configured in your project
Scrap	Rejects and QC samples are recorded	Configured in your project
FG usage decision	QA release is signed	Configured in your project

Interface rules

Orders are matched by number before they are created
SAP dates are planned dates. The BOM (Bill of Materials) is copied at release.
One batch number for bulk and pack, from SAP or from the numbering pattern
Expiry is dated from manufacture, sent as SAP's shelf-life date
Receipts always go into quality-inspection stock
A staging table with nightly reconciliation, and the flows sit inside the validation scope

44 of 77 typical URS requirements are ready today, including the Part 11 core.

44 ready · 16 configured · 17 on request, out of 77 typical requirements

Ready44

Order execution, recipe version frozen per order
Released-lot and expiry checks, FEFO with reason
Two-person dispensing and line-clearance signatures
IPC from machines, enforced limits
Non-conformance, hold, rework, scrap
Part 11: signatures, hash chain, audit trail, access log
Batch record PDF, genealogy to pallet
Two-person release step
DBR on the press, cleaning in the plan, OEE, maintenance

Configured in your project16

SAP postings and QM usage decision
Hold on every IPC failure
Equipment awaiting-cleaning state
Operator qualification check
Yield range check, recall report
Lab results into the record
Environmental monitoring by data point

Built on request17

Hard weighing tolerance, mandatory unlock reason
Reason for change, signed revision approval
Equipment logbook, clean and dirty hold times
Review by exception, archived batch record
E-signed NC disposition, CAPA (or a QMS)
Serialisation (BPOM 2D barcode)
Validation package (services)

Proof of Concept: dispensing, the press and one blister line, 6 to 8 weeks.

One product, against an SAP sandbox.

Area	Acceptance criterion
Material	A quarantined lot is refused at dispensing
Dispensing	Every component with weight, lot, scale and two signatures, and the step refused until both sign
IPC	30-minute checks from the tester without typing, and a failure holds the batch
Line clearance	Acknowledgements and two signatures before the first blister
Batch record	QA reviews a POC batch from the PDF, timed against a paper batch
Part 11	Your QA and CSV (Computer System Validation) team classifies each Part 11 control as product, configuration or procedure
SAP	Every posting has a document number the next morning, with zero reconciliation differences

Decisions we make together in the first workshop.

Regulators in scope: BPOM (Badan Pengawas Obat dan Makanan) only, or FDA (Food and Drug Administration) and export too
Validation approach and owner (GAMP 5, IQ, OQ, PQ)
Where material, bulk and FG release decisions live
Who owns the batch number and expiry
Shared terminal or own device for the second signer
How equipment cleaning and calibration are recorded

What changes, batch by batch.

Illustrative inputs from the worked example. Your own figures replace them in the Workshop Assessment.

What changes	Today	With VECHR MES
Unplanned press downtime	1.0 h a shift	0.9 h a shift
Review, documentation errors and SAP entry	About 13.6 h of manual work a batch	Reviewed on screen, posted by flows
Batches lost to a dispensing or record error	1 in 500	1 in 1,000

Frequently Asked Questions

Is VECHR MES validated for GMP?

VECHR MES is built on 21 CFR Part 11 principles. Validation for your site is a project deliverable, scoped in the Workshop Assessment.

Does it enforce the second-person check?

Yes. A step can require two signatures from different people, with password re-entry. The batch cannot move on until both have signed.

Does it work with SAP QM or a LIMS?

Yes. Lot status from SAP QM decides what can be consumed, and usage decisions go back. LIMS (Laboratory Information Management System) results arrive through a flow configured in your project.

What about CPOB?

The same controls support what CPOB (Cara Pembuatan Obat yang Baik) expects of electronic records: attributable, tamper-evident and reviewable. Our article on CPOB and electronic systems goes deeper.

Keep reading

Terms on this page(35)

21 CFR Part 11Title 21 Code of Federal Regulations, Part 11 (US FDA): The FDA rule for electronic records and electronic signatures: who did what and when, changes that stay visible, and signatures bound to the record they sign.
APIActive Pharmaceutical Ingredient: The ingredient in a medicine that has the therapeutic effect.
BOMBill of Materials: The list of materials, and how much of each, needed to make one product.
BPOMBadan Pengawas Obat dan Makanan: Indonesia's food and drug regulator. It inspects factories against CPOB.
CAPACorrective and Preventive Action: The follow-up to a deviation: fix the cause, then stop it happening again.
CPOBCara Pembuatan Obat yang Baik: Indonesia's Good Manufacturing Practice for medicines, enforced by BPOM.
CSVComputer System Validation: Documented proof that a computerised system does what it should, for its intended use.
DBRDrum-Buffer-Rope: A scheduling method that paces the whole line to its bottleneck (the drum).
FDAFood and Drug Administration (US): The US regulator for food and medicines. It publishes 21 CFR Part 11.
FEFOFirst Expired, First Out: Use the material that expires soonest first.
FGFinished Goods: The packed product, ready to ship.
GAMPGood Automated Manufacturing Practice: ISPE guidance for validating computerised systems by risk and by category.
GMPGood Manufacturing Practice: The rules that make sure products are made consistently and to quality standards.
GS1GS1 standards: The global body behind product barcodes and identifiers such as GTIN and SSCC.
IPCIn-Process Control: Tests taken during production, such as tablet weight or hardness.
IQInstallation Qualification: Proof that a system is installed as specified. The first of IQ, OQ and PQ.
LIMSLaboratory Information Management System: The lab's own system for samples, tests and results.
LODLoss on Drying: A moisture test: weigh, dry, weigh again.
MESManufacturing Execution System: The system that runs and records production on the floor: orders, materials, steps, quality and machines.
MMMaterials Management: SAP's module for materials, stock and purchasing.
NCNon-Conformance: A record that something did not meet its specification, with what happens to it next.
OEEOverall Equipment Effectiveness: Availability × performance × quality: how much of the planned time turned into good product.
OQOperational Qualification: Proof that a system works as specified across its operating range.
PLCProgrammable Logic Controller: The industrial computer that controls a machine and holds its live values.
PPProduction Planning: SAP's module for production orders and planning. PP-PI is the process-industry variant.
PQPerformance Qualification: Proof that a system performs consistently in real production use.
PVCPolyvinyl Chloride: The plastic film blister packs are formed from.
QAQuality Assurance: The team that releases product and owns the quality system.
QCQuality Control: The team, usually the lab, that tests samples against specification.
QMQuality Management: SAP's quality module: inspection lots, results and usage decisions.
QMSQuality Management System: The procedures and records a company runs quality by, such as deviations, CAPA and change control.
SAPSAP ERP: The ERP most large Indonesian manufacturers run. S/4HANA is its current generation.
SHA-256Secure Hash Algorithm, 256-bit: A fingerprint of a record. Change one character and the fingerprint no longer matches.
SSCCSerial Shipping Container Code: The 18-digit GS1 number that identifies one pallet or shipping unit.
URSUser Requirement Specification: The document that says what the plant needs a system to do. Validation tests against it.

See the full glossary →

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