THE CONNECTED SYSTEM
One record, wired end to end.
A value on the floor, a deviation, its CAPA, the change it triggers and the release decision are the same thread — not six systems stitched together after the fact.
Built for Indian pharma · Schedule M ready
A wrong number never becomes a deviation.
mg
● In spec — ready to seal
A Part 11 e-signature writes this step into the hash-chained audit trail. Type 298 and watch it refuse.
280285290295300
Book a callSchedule M · WHO-GMP · 21 CFR Part 11 · EU Annex 11
Try it — interactive sample
Type a weight. Watch it become a record.
Enter a compression weight against its specification. In or out of tolerance, every action lands in the hash-chained audit trail — the same mechanics the product runs on.
eBMR · compression · fill weightBT-2026-SAMPLE-01
Interactive sampleValue290mg
285290295
Electronic signature — sample
In spec. Sealing the step records a Part 11 e-signature into the hash-chained audit trail.
Hash-chained audit trail · sampleappend-only
09:02:11A. RaoDISPENSEDBT-2026-SAMPLE-01 · Paracetamol 500 mg · lactose 42.000 kg4f9a17…e0b8d3
10:47:36S. MenonIN-PROCESSBT-2026-SAMPLE-01 · granulation LOD 2.1%b1c6e9…72f0aa
12:15:04S. MenonSIGNEDBT-2026-SAMPLE-01 · compression stage verifiedd83f20…c19b47
TWO WAYS TO KEEP A RECORD
The binder, or the thread.
PAPER & SPREADSHEETS
- Pages photocopied, hand-signed, filed in binders
- Corrections overwrite the original — history is lost
- Deviations tracked in email and spreadsheets
- An audit means reconstructing the trail from scratch
STIBAOS · ONE THREAD
- One living record, executed at the machine
- Every edit kept, with reason-for-change, nothing overwritten
- Deviations, CAPA and change control on the same thread
- The audit trail is hash-chained — export it, don’t rebuild it
THE MODULES
Every function the plant runs on.
21 modules, each gateable — tenants switch on only what they run. This is the actual set that ships, grouped the way the product itself is.
Overview2
- KPI Dashboard
- What-If Simulator
Quality Control6
- Documents
- Deviations
- CAPA
- Change Control
- Laboratory
- Stability
Manufacturing2
- Batch Records
- Production
Facility3
- Equipment
- Environmental
- Digital Twin
Supply Chain3
- Inventory
- Suppliers
- Distribution
Compliance & Audit5
- Inspection Readiness
- Audit Management
- Training (LMS)
- Regulatory
- Support & Schemes
DO YOUR OWN MATH
The numbers are yours, not ours.
Enter what your plant actually runs. Everything below is plain arithmetic on those figures — including a review-reduction you set yourself.
Review reduction you expect50%
YOUR ESTIMATE
- BMR review hours / year
- 960 hrs
- Cost of those hours / year
- ₹ 8,64,000
- Deviations logged / year
- 96
Review hours saved / year480
Value of those hours / year₹ 4,32,000
COMPLIANCE, MAPPED
Each clause, to what the system does.
Not a claim that you are compliant — the controls the platform provides against the frameworks Indian pharma is inspected under.
CDSCO · INDIA
Schedule M 2024
- Self-inspection (§12)
Inspection-readiness module scores gaps against live Schedule M sections with evidence.
- Change control (§3.7)
Change records require impact assessment, approval workflow and traceability to affected documents and batches.
- Deviation & CAPA (§3.5, §3.6)
Deviations link to root cause, CAPA, effectiveness check and closure evidence across the lifecycle.
- Documentation (§3.4)
eDMS enforces version control, approval workflow, periodic review and retention.
- Training (§3.3)
Role-based training plans with competency assessment and evidence of completion.
US FDA
21 CFR Part 11
- §11.10 Closed-system controls
Validated access, audit trail, sequencing, device and authority checks.
- §11.50 Signature manifestations
Every signed record displays signer name, date, time and meaning of signature.
- §11.70 Signature/record linking
Signatures are cryptographically bound to the record; removal invalidates it.
- §11.300 Identification controls
Credential uniqueness, complexity, periodic expiry and deactivation after failed attempts.
WHO TRS 1033
WHO-GMP
- Quality system (Annex 2)
Quality modules map to WHO TRS 1033 good practices for pharmaceutical quality control.
- Data integrity (ALCOA+)
Entries are attributable, time-stamped and kept on a hash-chained audit trail.
- Documentation & records
One-click export of batch record, audit trail and training status for review.
SEE IT ON YOUR OWN RECORDS
A walkthrough with your BMR formats and your release workflow.
No canned tour — bring a real batch and we will run it through the system with you.