QA Stack

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eBMR Software — Replace Paper Batch Records with Electronic Execution

Configurable electronic Batch Manufacturing Record software for pharma sites. Replace paper MBRs with structured digital execution — line clearances, material dispensing, in-process checks, yield reconciliation, and Review by Exception. Compliant with 21 CFR Part 11, WHO-GMP, and CDSCO norms. Deployable standalone or alongside your eQMS.

Active Batch Record
BTH-2026-0831
In Progress
Phase 2: Material Dispensing
Verify Line Clearance
Completed by A. Sharma at 08:14 AM
Scan Material: Active API
Lot #1044-A verified successfully.
Record Dispensed Weight
450.0 g
Sign
Master Batch RecordsDispensing & WeighingBatch ExecutionYield ReconciliationBatch Exception ReviewPart 11 Audit Trail

Benefits of moving to eBMR

  • Faster release cycles: Reduce batch release time with review-by-exception and automation.
  • Reduced human error: Enforce real-time checks and instrument captures during execution.
  • Complete traceability: Maintain tamper-evident audit trails for every batch execution.
See eBMR in Action

eBMR Sub-Modules

FDA 21 CFR Part 11 Compliant Electronic Batch Records

Precision from the very first step.

Translate your paper MBRs into dynamic, version-controlled electronic workflows. When execution begins in the dispensing booth, operators are guided through strict material scanning and integrated scale weighing.

Step 01

MBR Authoring

Authors create Master Batch Records using structured compliance templates.

Right-first-time manufacturing.

Operators are guided step-by-step through the process. The system forces critical parameters (temperature, speed) to be within spec before allowing progression. Yields are calculated automatically, eliminating manual calculation errors.

Step 01

Line Clearance

Operators verify equipment and room status and log line clearance checklists.

Review by exception. Release in hours.

Because data is verified at the time of entry, Quality Assurance no longer needs to flip through hundreds of pages of paper. The system highlights only deviations, overrides, and critical alarms for QA review.

Step 01

Execution Complete

Batch execution finishes, locking all records and compiling audit trails.

OT/IT Convergence

Secure Shop-Floor to Cloud Data Pipeline

QA Stack bridges the gap between Operational Technology (OT) on the manufacturing floor and corporate IT database systems. We enable automated yield calculations and scale integrations without compromising GxP data integrity.

System Architecture

From Shop Floor to eBMR

Secure, validated data flow across OT, Edge, and Cloud layers

LEVEL 1/2OT Layer

Balances, PLCs, & Scales

Weighing balances (Mettler Toledo, Sartorius) and PLCs (Siemens S7, Allen Bradley) execute material dispensing and blender cycles.

SCALE_042124.50 kg NET
⚲ OPC-UA•⚲ Modbus
LEVEL 3Industrial DMZ

GxP Edge Gateway

Isolated network gateway parses raw serial and register streams. Validates data checksums and manages temporary buffer storage in case of network drops.

GATEWAY_MODETLS 1.3: ENCRYPTED
🔒 HTTPS TLS 1.3•🔒 MQTT encrypted
LEVEL 4Cloud Layer

QA Stack Cloud DB

Raw weights, mix durations, and IPC values are written directly to eBMR database layers. Auto-raises deviations if inputs fall outside MBR thresholds.

IMMUTABLE LOGPart 11 status: LOCKED
✓ Immutable SQL•✓ Part 11 locks
21 CFR Part 11Compliant
End-to-EndEncryption
Audit Trails &Traceability
GxP ValidatedArchitecture

Component-Level Workflow Gating

Every step is a controlled, state-driven unit of work. Below is the dynamic stage gating logic mapped directly to our `StageContentRenderer` architecture.

Compliance Architecture

eBMR GAMP 5 & 21 CFR Part 11 Compliance Matrix

GxP / FDA ClauseRegulatory RuleQA Stack eBMR Implementation Solution
GAMP 5 Cat 4Software must be configurable to match business rules without modifying source code.
Structured recipe builder configures stages, inputs, and tolerances dynamically. Version-controlled recipes lock upon approval.
Part 11.10(b)System must limit access to authorized individuals and enforce active step dependencies.
Active Directory SSO integration. Gating logic prevents executing step N before step N-1 completion sign-off.
Part 11.70Signature and record linkages must be maintained to prevent signature cloning/forgery.
Dual-credential authentication modal prompts on every step execution. Cryptographically links StepSignature to batch data hash.
Part 11.10(k)Use of appropriate controls over system documentation, distribution, and access logs.
Immutable DB audit logs trace recipe distributions, batch initiations, deviations raised, and supervisor releases.
Technical Q&A

Frequently Asked Questions

How does the eBMR handle connection losses on the shop floor?+
The QA Stack eBMR uses an offline-first execution architecture. If connectivity to the cloud is lost during active batch processing, local browser storage caches executed steps, IPC entries, and local user signatures. Upon reconnecting, the edge service validates data checksums and syncs cached records back to the central database.
Can we connect QA Stack directly to weighing balances and PLCs?+
Yes. We utilize standard industrial edge gateways supporting OPC-UA, MQTT, and Modbus RTU/TCP protocols. This allows our system to pull raw weight data directly from scales during excipient dispensing, and capture critical process parameters (CPPs) directly from PLC blenders, eliminating manual data transcription.
What is Review by Exception (RBE) and how does it speed up release?+
Traditional batch release requires QA to review every page of a paper record. QA Stack eBMR automatically tracks process variables against recipes in real time. If all steps completed within limits and zero deviations occurred, the RBE dashboard flags the batch as "green," allowing QA to sign off immediately. If deviations occurred, the system displays only those exceptions for targeted review.
How is data audit trailing handled during corrections?+
If a signed step requires correction, QA must initiate the Step Unlock flow. The system prompts for credentials and a reason code, unlocks the step, and logs a correction event. When the operator edits and re-saves the data, both the old value and the new value are preserved in the immutable SQL audit trail, preventing data deletion.