Batch release delays rarely come from the process. They come from a paper record with a missing initial or an uncalculated yield. We build electronic batch record software from your own MFR and SOPs, enforcing sequence and limits at execution so the record is right before QA sees it.
Steps unlock in the approved order, with interlocks on equipment status, material identity and prior signature.
Electronic signatures with meaning, timestamp and identity, backed by a secure computer-generated audit trail.
QA reviews deviations and out-of-limit entries instead of checking every routine line of a compliant batch.
A complete paperless batch execution capability covering MFR digitisation, enforced execution, equipment data capture, review workflow and validation support, engineered with your QA and production teams.
The approved master formula record becomes an executable recipe, with your own step wording, limits and calculations retained. Version control is enforced so a superseded MFR can never be issued to the floor.
The operator cannot proceed out of sequence, use uncleaned equipment or charge the wrong material. Enforcement at the point of execution removes errors your QA team currently finds days later at review.
Values that come from an instrument should never be typed by hand. We integrate balances, dispensing booths and process equipment so the record carries the reading the instrument actually produced.
Once execution is enforced, review can focus on what went wrong instead of confirming what went right. Deviations raised on the floor carry straight into your existing quality management process with evidence attached.
Technology selected for a regulated process plant, where every interface has to be qualified and every record must stand up to inspection.
The application and its database are built and documented to support formal computer system validation, with change control applied from the first build.
Balances, dispensing booths, reactors and process skids are interfaced so readings enter the batch record directly from the source instrument.
Material containers, equipment, rooms and operators carry scannable identities, which is how interlocks are actually enforced at the point of use.
Deployed on-premise or in a private cloud with the access, backup and retention controls a data integrity inspection will examine.
Representative outcomes from process manufacturing deployments. Figures are indicative ranges typical of this solution type and must be confirmed against your own baseline before publication.
CDSCO-licensed plants running granulation, compression, coating and packing with a high batch documentation load.
FSSAI-licensed operations meeting export customer audit requirements alongside their existing domestic regulatory and labelling obligations.
Multi-product plants where charging sequence and process parameter control carry direct safety consequences for operators.
Measures agreed with the QA head, production head and IT compliance lead at design sign-off, and reported from the first validated batch.
Elapsed time from batch completion on the floor to QA release of that batch.
Target: Reduced 40-60%
How we get there: Achieved because the record arrives complete and only exceptions need detailed review.
Share of batch records reaching QA with no missing entry, signature or calculation error.
Target: >98%
How we get there: Enforced at execution through mandatory fields, automatic calculations and signature checks.
Coverage of the secure audit trail across record creation, change and deletion events.
Target: 100% of events
How we get there: Built into the data layer, so no transaction can be written without an attributable entry.
Time from a deviation being raised on the floor to formal closure in the quality system.
Target: Reduced 30-50%
How we get there: Shortened by raising the deviation at the step with its context and evidence attached.
A validation-led sequence, because a paperless record that is not qualified is not usable.
We review your master formula records, SOPs, equipment list and existing quality systems with your QA head, and produce a user requirement specification for sign-off.
Recipe structure, interlocks, signature points, role matrix, audit trail scope and instrument interfaces are documented in functional and design specifications.
One product is executed paperless end to end against acceptance criteria, initially running alongside the paper record so QA can compare both before cutover.
IQ, OQ and PQ documentation is executed, remaining products are configured in phases, users are trained, and the system moves into a validated-state support contract.
Why regulated manufacturers build an eBMR around their own quality system instead of licensing a fixed platform.
We digitise the procedures you have already justified and approved. Rewriting SOPs to fit a product template creates a change control burden with no quality benefit.
URS, FS, DS, traceability matrix, IQ, OQ and PQ protocols are prepared and executed with your QA and IT compliance leads as part of the engagement.
ALCOA principles, attributable signatures, time synchronisation, secure audit trails and controlled archival are all designed in from the beginning.
Balances, booths and process equipment are physically integrated and qualified, so the record holds source data rather than values transcribed by an operator.
Book a requirement discussion with our engineering and validation team. We will review a representative MFR, your equipment list and your current review process, then return with a scoped pilot product, a validation plan and an indicative timeline.
Electronic batch record software, often called eBMR or eBR, replaces the paper batch manufacturing record with an executable electronic version of the approved master formula record. The operator follows the batch on screen, steps unlock only in the approved sequence, weights and process parameters are captured directly from instruments, in-process checks are evaluated against specification automatically, and every entry is signed electronically into a secure audit trail. Quality then reviews the completed record by exception, focusing on deviations and out-of-limit results rather than checking every routine entry.
It is built for your plant. We are a custom solution development and systems integration company, not a SaaS vendor. The engagement begins with a requirement study and a user requirement specification signed off by QA.
It is built to meet them. Electronic signatures carry the signer identity, date, time and meaning of the signature, records are protected against unauthorised change, and the audit trail is secure and computer generated.
Yes. We prepare and execute the validation package with your QA team, covering user requirement, functional and design specifications, a traceability matrix, risk assessment, and IQ, OQ and PQ protocols with reports.
Yes. Balances, dispensing and sampling booths, and process equipment interfaced through PLC, SCADA or DCS are connected so weights and parameters enter the record directly from the instrument, removing transcription error.
Yes. We integrate with SAP, Oracle, Microsoft Dynamics and Navision and in-house systems for production orders, batch data and yield postings, and with existing QMS or LIMS applications for deviation, CAPA and results.
Yes, and most regulated plants choose on-premise or private cloud. The architecture supports both, with documented data residency, backup and restore procedures, retention and archival rules, and qualified infrastructure covered in the installation qualification.
A pilot on one product line, including validation documentation, typically takes twelve to twenty weeks from requirement sign-off, depending on recipe complexity, instrument integration count and your validation policy. Further products follow in phases.
The design includes defined business continuity provisions. Execution terminals hold the active batch context locally, servers are deployed with redundancy suited to your risk assessment, and an approved contingency procedure covers reverting to paper.
Support runs under an agreed contract covering defined response times by severity, maintenance of the validated state through controlled change, recipe authoring for new products, instrument interface support and periodic review assistance.