eBMR
Prove every batch
Guided execution that cannot be quietly rewritten.
- Step by step, with live limit checks
- Signatures that carry a meaning
- Review by exception
- Release as a gate, not a click
The Digital Manufacturing Platform
One system for the
batch.
Proof included.
eBatchWise brings the MES, the electronic batch record, logbooks and cleaning validation together for pharmaceutical manufacturers. One sign-in, one set of master data, one audit trail.
Tablets first. Liquids, semi-solids, capsules and sterile products on the same platform.
Select a part of the diagram: ERP, eBMR, PeakPulse or plant equipment.
0modules: MES, eBMR, Logbooks, Cleaning validation
0services, each with its own database
0role guides in the training manual
0in-app help topics, one per screen
The platform
Four jobs. One system.
Most plants run these on separate tools and re-key between them. Here they share one sign-in, one set of master data and one audit trail, so the record, the order and the machine tell the same story.
MES
Run the plant
From the ERP order to the dispensing station and back. Explore the MES →
- Production orders in, results out
- Planning cockpit and line calendars
- Warehouse, pick, stage, dispatch
- On-time-in-full and plan against actual
LOGBOOKS
Record the rest
Area, utility, shift and pest-control books, handover acknowledged, never rewritten.
CLEANING VALIDATION
Show it stays clean
Optional module: limits, worst case, protocols, results, status board and an inspection package.
OEE PLATFORM
Know how it ran
Our separate OEE platform reads the same batch events, tying downtime and performance to the batch.
The MES
Run the plant, from the ERP order to the weighing.
The manufacturing execution layer is part of the same system as the batch record. Orders arrive from your ERP, get planned onto lines, material is picked and dispensed, and the results go back, with no re-keying and one audit trail.
1ERP order in
→
2Plan on a line
→
3Pick and stage
→
4Dispense
→
5Execute the batch
→
6Results to ERP
Place the order where it can actually run
Order ORD-1042 (Tablet X 50 mg, 200 kg) is promised for Friday 17:00. Choose a line and see what the planner sees before signing.
- A line that is not qualified for the product is refused.
- Equipment, material and the promised time raise warnings in words.
- Changeover time comes from the last product on the line.
- Committing is a signature, and plan against actual is measured afterwards.
Planning cockpit
First-expiry-first-out, enforced
The batch needs Lactose. Three lots are in the warehouse. Pick one to scan into the batch.
- The lot due first is recommended.
- Using a lot due later needs a reason, and it is audited.
- A quarantined lot cannot be scanned in at all.
Pick: Lactose, 60 kg
- L-2301 · expires 30 Nov 2026 · released
- L-2302 · expires 15 Feb 2027 · released
- L-2290 · expires 10 Dec 2026 · quarantineQA not released
The station asks for one thing at a time
Lot, source container, target container, tare, weight. Here, the weight. The target is 25.000 kg with a tolerance of 2 %, on a balance with a 0.2 kg minimum weight and a 60 kg capacity.
- The target comes from the scaled recipe, adjusted for potency.
- The balance's capacity and minimum weight are checked on every reading.
- An accepted weighing is signed, labelled and booked against the lot.
Dispensing: Lactose
Target 25.000 kg · accepted 24.500 to 25.500 kg
ORDERS
From your ERP
Orders arrive by message, file or hand, are released by signature, and the ERP is told when the batch starts, consumes, completes and is released.
PLANNING
Cockpit and calendars
Line calendars, changeover rules, proposals, and a signed commit. Plan against actual is measured.
WAREHOUSE
Receive to dispatch
Put-away by scan, FEFO picking, returns, pallets with GS1 labels, and dispatch of released goods.
ANALYTICS
On time, in full
OTIF, batch times, right-first-time and delay reasons, with a published contract for PeakPulse and BI tools.
A batch, start to finish
From order to release, without the paper.
Each stage has an owner, a check and a signature. The people who make a record are never the people who release it. Select a stage.
Try it
Don't take our word for it. Break the rules.
These are small working models of real controls. They run in your browser, send nothing and store nothing.
Values are judged as they are typed
Tablet hardness has specification limits of 6.0 to 12.0 kP and tighter alert limits of 6.5 to 11.5 kP. Try 9, then 6.2, then 14 (twice).
- Inside alert limits: accepted.
- Between alert and specification: a comment and a Minor exception.
- Outside specification: confirm, give a reason, and a supervisor must sign an override.
Step 4: Compression, hardness
A signature is your password, again
Being signed in is never a signature. Sign as the performer, then try to verify your own work. Then choose someone else.
- Every signature records its meaning, the person, the time and the exact record.
- Maker and checker must be different people.
Weighing step: signatures
History that shows when it was touched
Each audit entry is chained to the one before it with a SHA-256 hash, computed here in your browser. Add entries, then tamper with an old one.
- Change one entry and it, and everything after it, stops matching.
- The chain detects tampering. It does not replace access control or backups, and we say so.
Audit trail, batch B-2604
Reviewers read what matters first
Switch to the full record, then back. Accept each exception to unlock the QA signature.
- Exceptions, corrections and late entries come first, with the events around them.
- Release is a separate signature by someone who took no part in the batch.
Review: batch B-2604
Built for the people who use it
A workspace for every role.
People see the screens their role allows, per site. A manual, one-page quick cards and in-app help are written for each role.
Compliance by design
Controls built in, not bolted on.
eBatchWise supports the controls of 21 CFR Part 11, EU Annex 11 and ALCOA+. Each one is enforced by the server, not just hidden in the screen. Filter by framework.
Signatures that mean something
Every signature re-asks for your credentials and records its meaning: performed, verified, reviewed, approved or released. Being signed in is never a signature. The signature is stored with the exact record and its hash, in the same transaction. If signed content changes, the signature shows as no longer valid.Relates to Part 11 subpart C and Annex 11 clause 14.
Records are never overwritten
A correction adds a new value beside the old one, with the reason, the person and the time. Signatures and audit entries are append-only and blocked from update or delete in the database.Original, Complete, Enduring.
A secure, computer-generated audit trail
Every create, change and refusal is recorded with who, what, when, the old and new values and the reason, chained with SHA-256 per site, shown in plain words, printable, and checked daily. The chain detects tampering. Access control, role separation and backups still matter, and we say so.Relates to Part 11 audit trail controls and Annex 11 clause 9. Attributable, Contemporaneous.
Maker and checker are different people
The author of a recipe cannot approve it. The performer cannot verify. The releaser must have taken no part in the batch. The person who placed a hold never lifts it. These are enforced at the action, on the server.
Server time, one format
Timestamps are the server's, not the terminal's. A late entry is a separate, reasoned action with the real time and a second-person check.Contemporaneous, Accurate.
A frozen recipe
A batch runs on a snapshot of the approved recipe with a content hash. Later recipe changes never reach a running or finished batch.Consistent, Accurate.
Records that last and can be found
The final batch record is a PDF/A file with its SHA-256, stored read-only, with the batch's audit trail archived beside it. Search, print and export are built in.Relates to Annex 11 clauses 7 and 17. Enduring, Available.
Access, sessions and security
Roles per site, password policy, lockout, idle sign-out, or sign-in through your company directory. Services are hardened and a security assessment has been run against the platform.Relates to Annex 11 clause 12.
eBatchWise supports these controls. It is not described as certified: your company owns validation, your SOPs and the decision that a control is adequate. We provide a requirements specification, a design specification and a draft qualification protocol to help.
About us
Built by Kevision, for regulated manufacturing.
eBatchWise comes from Kevision, a member of Kevin Group, headquartered in Ahmedabad, Gujarat, India. Since 2016 Kevision has built software and systems that protect the authenticity of medicines and other regulated products.
0+production lines protected by Kevision systems
0+countries with delivered projects
0+customers, from pharma to agro
2016year Kevision was founded
Figures describe Kevision as a company, not eBatchWise alone.
Our purpose
To protect the authenticity of medicines and products. Kevision started with serialization and camera-based inspection, and has grown across life sciences, food and beverage, tobacco, agro and the supply chain.
One standard measures everything we build: does it keep the line running and the regulators satisfied? Technology that works on the line, not just in a presentation.
MISSION
Deliver software, hardware and systems that keep medicines, food and regulated products genuine, safe and traceable.
VISION
To be the most trusted name in regulated manufacturing, known for technology proven on the line.
VALUES
Reliability, innovation and customer success, with hands-on support behind every system.
A decade of building
Industries we serve
PharmaceuticalsAPI and bulk pharmaAgrochemicalFood and beverageTobacco3PL and contract manufacturing
Kevision is part of Kevin Group, led by Ketan Khambhatta, Managing Director. Headquarters: Ahmedabad, Gujarat, India, with projects delivered worldwide. More at www.kevision.in.
Questions
What people ask first.
Is eBatchWise Part 11 compliant?
It supports the controls of 21 CFR Part 11 and EU Annex 11, such as unique signatures, audit trails and record protection. Compliance is a property of your validated use, so your company owns validation. We supply requirements, design and qualification documents to support it.
Which dosage forms does it cover?
Tablets first, with dispensing, granulation, compression, coating and packaging. Liquids, semi-solids, capsules and sterile products are supported through configuration and dedicated field types such as sample sets, process traces, aseptic interventions and lyophilisation cycles.
Can it work without our ERP?
Yes. Orders, lots and training can be entered or imported by file, and switched to ERP-fed when you connect it.
Does it run offline on the shop floor?
Not today. Servers sit on the plant network. Offline execution is planned only after a design is accepted.
What is PeakPulse?
PeakPulse is our separate OEE platform. It reads the same batch events as the eBMR so availability, performance and quality can be tied to the batch that ran.
Is cleaning validation required?
No. It is an optional module. The core system works with manual cleaning records without it.
See it with your own process
Book a live demonstration.
Bring a recipe. We will walk a batch from order to release on your terms, including the review and the audit trail.