Production
eBMR and eBPR execution
Dispensing requires second-person verification, and line clearance blocks the next stage until the previous one is closed.
IndustriesPharmaceuticals
• Pharmaceuticals
The batch record writes itself as the batch runs
Quality works as a gate, not a review after the fact. Evidence sits on the record it belongs to, so the audit pack is a download, not a project.
Supported frameworks, not certifications. Regulatory updates included.
The evidence travels with the batch.
- 01Manufacturing record
- 02Laboratory results
- 03Signed QA release
20 configured controlsFDA 21 CFR Part 11 · EU Annex 11 / EU GMP · Revised Schedule M
One controlled record
Why now
Schedule M is not a deadline.
It is an inspection now.
No turnover band has a grace period left. What used to be prepared before an audit now has to exist every day.
- The obligations are continuous
A pharmaceutical quality system, quality risk management, product quality review, lifecycle validation, computerised system controls and data integrity.
- They have to be a by-product of work
Assembled the week before an inspection, they show that work produced as the batch runs is missing.
- The same engine runs every industry
These controls run on the Compliance Engine, the one every Factro pack uses.
What is tailored
Built for the batch,
enforced at every step.
Where the Pharmaceuticals pack changes how the core behaves.
Quality
Results attach to their stage
In-process results attach to the stage that produced them, with out-of-specification and out-of-trend investigation routed automatically.
Inventory
Quarantine enforced by the system
Quarantined material is structurally refused at the point of dispensing — the control is the system, not a label on a drum.
Facility
Calibration as a gate
Calibration blocks the stage the moment it lapses, instead of surfacing weeks later as a batch-level finding.
Built for pharmaceuticals
The Schedule M work, done in the record.
Not beside it.
These features switch on with the pharmaceuticals pack. They sit on the same ERP, MES and QMS every Factro plant runs.
01 / Inventory · Assay-adjusted dispensing
The lot’s assay sets the quantity.
Assay and LOD are recorded against each API lot at receipt. Dispensing recalculates the quantity to deliver the labelled amount of active, and the balance holds the tolerance for an API. Nobody reaches for a calculator on the floor.
- 01Quantity from the lot.
The assay and LOD recorded at receipt set the quantity to weigh, with the calculation shown on the step.
- 02Released lots only.
A quarantined lot is refused at the point of dispensing. The control is the system, not a label on a drum.
- 03Weighed, then checked.
The balance records only inside the tolerance, and a second person verifies the weighing before the next stage opens.
02 / Library · MPCR and MFR
Plan and run on your MPCR and MFR.
Master production and control records and master formula records are versioned under change control. Every work order is pinned to the approved version, from BOM and dispensing through IPQC, packing and finished-product testing.
- 01One approved revision.
Each MPCR and MFR is revised under change control, and only the approved revision can be issued to a work order.
- 02Pinned at issue.
A work order keeps the revision, BOMs and batch documents it was issued with. A later revision applies to future batches only.
- 03Every part in one record.
BOM, weighing and dispensing, MBR, IPQC, MPR and FPT sit together, so nobody plans from a stale copy.
03 / Production · eBMR and eBPR
The BMR prints from the record.
Batch manufacturing and packing records are completed at the step, with readings, signatures and deviations. The printed BMR carries the fields an inspector reviews first, without a second copy to reconcile.
- 01Recorded at the step.
Quantities, lots, readings and signatures are entered as each step is done, not copied up at the end of the shift.
- 02Deviations where they happen.
A reading outside its limit raises a deviation on that step, with the stage and the reading already attached.
- 03Review, not reconstruction.
QA sees missing entries before final review and reads the exceptions. The printed BMR comes from the same record.
04 / Sales and purchase · Drug licence checks
No current licence, no order.
Customer and vendor drug licences sit on the account with their validity dates. A sales order or PO against a lapsed licence is refused, and the renewal shows up as work before it lapses.
- 01Licences on the account.
Each customer and vendor keeps its drug licences, numbers and validity dates on its own record.
- 02Renewal before the lapse.
A renewal task opens 60 days before a licence expires, with an owner and the request sent.
- 03Checked on every order.
Confirmation checks the licence alongside credit and stock. A lapsed licence stops the order, whoever raises it.
Schedule M, continuously
Six obligations.
Produced as you work.
Each continuous obligation in Revised Schedule M, and the records in Factro that answer it.
Pharmaceutical quality system
Evidence in FactroSOP governance, deviations routed into CAPA, self-inspection and APQR.
Lives inControlled documentsQuality eventsQuality assuranceQuality risk management
Evidence in FactroA risk register with FMEA scoring, linked to the process steps it covers.
Lives inQuality eventsWork ordersProduct quality review
Evidence in FactroThe annual product quality review assembled from batch records, not rebuilt by hand.
Lives inWork ordersQuality assuranceLifecycle validation
Evidence in FactroURS, IQ, OQ and PQ traceability matrices on validation-ready workflows.
Lives inShop floorLaboratoryComputerised system controls
Evidence in FactroField-level access, re-authenticated approvals and backups with point-in-time recovery.
Lives inEvery moduleSecurityData integrity
Evidence in FactroALCOA+ across records, on an append-only, hash-chained audit trail.
Lives inAudit trailEvery module
Controls
20 controls.
6 standards.
Every control below runs on the Compliance Engine. The same record carries the evidence across the plant.
13 controls shown for 21 CFR Part 11
Append-only, hash-chained audit trail capturing old value, new value, author, time and reason
Immutable records, secure archives and no hard delete of GxP data
Re-authenticated approvals capturing the approver, time and meaning on every sign-off
Role-based access control, down to the individual field
Segregation of duties enforced in the system, maker is never checker
Linked-record architecture carrying full data lineage end to end
Electronic batch records across MFR, BMR and BPR
Approval workflows with role-based, re-authenticated sign-off
Production planning with batch, lot and vendor qualification traceability throughout
Validation-ready workflows with URS, IQ, OQ, PQ traceability matrices
Audit-ready exports in inspector-readable form, on demand
ALCOA+ data integrity enforced across every record, attributable through to available
Automated redundant backup with point-in-time disaster recovery
Regulatory change
We watch the rules.
You do not have to.
The Compliance Engine tracks the rules that apply to you, works out what a change touches, updates the system and re-validates before release. You file no change request.
- • applied
21 CFR Part 11 takes effect
FDA set the criteria for trustworthy electronic records and signatures. Audit trails, signature meaning and access controls in the pack map to it.
- • applied
Revised Schedule M notified
India’s revised GMP schedule was published, with phased deadlines by turnover band. The pack’s quality risk management and computerised system controls track its clauses.
- • applied
Schedule M pack shipped ahead of enforcement
Facility segregation, quality risk management and computerised systems controls were built into the rule set and validated before the phased deadlines landed, not after.
- • applied
Revised Schedule M enforcement
No grace period across every turnover band, with state drug controllers reporting inspections monthly to CDSCO.
- • monitoring
EudraLex Volume 4 Annex 11 & new Annex 22
Chapter 4 on documentation and Annex 11 on computerised systems, alongside a new Annex 22 on artificial intelligence. Public consultation closed in October 2025, and the pack follows the revisions into the product as they land.
Validation readiness
Controls built in,
not configured on top.
Validation packs
Available on the Dedicated tier, mapped to your workflows. URS, IQ, OQ, PQ, RTM and GAMP 5.
ISO 27001
Certification in progress. Encryption, access control and backups are described on Security & Trust.
Readiness, scored
The Compliance Engine scores inspection readiness continuously, with guidance on each open gap.
Make it your workflow
Have a requirement
to walk through?
Bring the regulation that keeps you up at night. We will show you the control that answers it, on a batch from your plant.