BatchQuest - Electronic Batch Record Solution

Set up operations with accurate, validated instructions

Approved process digital workflows bring together SOPs, product data, and readiness rules in one place.

Teams define how work should be done—once—so it can be executed consistently across every batch. Once the manufacturing process is defined, BatchQuest compiles all instructions, materials, parameters, and checks into a validated, version-controlled Master Batch Record (MBR), so everything is in place before execution begins.

Key Capabilities:

• Digital Batch Templates: Create standardized and approved operations with pre‑configured manufacturing process workflows that eliminate variation.
• No‑Code Configuration: Build and update batch definitions quickly. No custom development or scripting required.
• Integrated Product and Equipment Data: Bring product data, specifications, engineering changes and required equipment to use directly into production.
• Document and Change Control Integration: Ensure operators always work from the correct, approved version of SOPs and parameters.

Create ready to execute batch records

Once the manufacturing process is defined, BatchQuest compiles all instructions, materials, parameters, and checks into a validated, version-controlled Master Batch Record (MBR), so everything is in place before execution begins.

Key Capabilities:

• Bill of Materials Integration: Automatically pull the correct Bill of Materials (BOM) into each batch.
• Template Configuration: Add other items such as weighing, sampling, dispensing, packaging, and more through easy configuration.
• Automated Readiness Checks: Validate that materials, equipment, and personnel meet all pre‑execution requirements.
• One‑Click EBR Generation: Instantly create executed batch records from approved templates.

Prevent errors during execution

Operator execution is guided step by step. Training is verified before steps run. Inputs are validated as entered, and evidence is captured automatically, so issues are prevented before they become deviations.

Key Capabilities:

• In‑Process Verification: Enforce validated steps with automatic checks for parameters, ranges, and decision logic.
• Training Enforcement at Execution: Prevent execution of batch steps unless operator training and authorization requirements are met.
• Barcode Scanning & Evidence Capture: Track materials with lot/serial scanning and attach images, videos, or documents as proof.
• Multi‑Device Access: Execute batches on desktop, tablet, or mobile - on the shop floor or remotely.

Faster release with Review-by-Exception

Instead of reviewing entire records, quality teams focus only on exceptions. Complete, audit-ready batch records are compiled automatically as soon as execution ends, shortening release cycles.

Key Capabilities:

• Review‑by‑Exception: QA reviews only the flagged steps, reducing release time dramatically.
• Integrated Quality Management (QMS): Link execution to non-conformance, training, and change control workflows.
• Seamless System Integrations: Connect easily with ERP, MES, and enterprise systems through CQ’s integration framework.
• 21 CFR Part 11 Compliance: Maintain secure, validated electronic records with full audit trails and e‑signatures.
• Audit‑Ready Reports: Generate eDHRs/Batch Records instantly for inspections or customer requests.