Electronic Batch Records
Manage Batch Records
From Setup Through QA Review.
Build electronic batch records around your manufacturing process. Capture production data as work happens, track deviations, and give your quality team the information they need to review each batch.
Batch Record Setup
Start With the Batch Records You Already Use.
Use your existing batch records as the starting point for reusable electronic templates. Organize each template into unit procedures, operations, and phases, with the instructions and fields your process requires.
Existing Records
Start from the batch records your team already uses.
Process Structure
Organize records by unit procedure, operation, and phase.
Required Information
Define the information operators need to capture as work is performed.
Reusable Templates
Use the approved structure to create individual batch records.
Batch Execution
See Where Every Batch Stands.
Operators enter production data as they complete each phase. Your team can follow batch progress, review recorded values, and see which steps still need attention.
Electronic Execution
Capture required information directly in each phase of the record.
Progress Tracking
See completed and remaining phases as the record moves forward.
Connected Data
Use recorded data in downstream workflows through configured connections.
QA Review
Focus Review on What Needs Attention.
Flag recorded values that fall outside configured limits for quality review. Track each exception through acceptance, then complete final QA signoff once execution and required reviews are complete.
Exceptions
See items requiring Quality review.
Review Status
Track what has been accepted and what remains pending.
Final QA Signoff
Complete final Quality signoff once required exceptions are addressed.
Deviations
Handle Deviations Without Losing the Batch Context.
Review and disposition deviations alongside the batch information that prompted them. Keep supporting evidence with the deviation and escalate to a nonconformance when further investigation is needed.
Batch Context
See the batch record, phase, requirement, and value associated with the deviation.
Classification & Disposition
Classify the deviation and document how it should be handled.
Supporting Evidence
Add justification and supporting files as part of the review.
Quality Escalation
Escalate into the appropriate Quality process when further investigation is required.
Frequently Asked Questions
Can we start from our existing batch records?
Yes. Existing batch records can be brought into Cytodyme to help build the electronic record, rather than recreating the process from scratch. The record can then be structured around the procedures, operations, phases, and information your process requires.
Can Cytodyme support DMR and DHR workflows?
Cytodyme can structure electronic production records around medical device manufacturing processes. We review your master record and executed record requirements during setup to confirm how they map to the platform.
How does review by exception work?
Cytodyme surfaces exceptions from batch execution for Quality review. Reviewers can see what requires attention, track accepted and pending exceptions, and complete final QA signoff once the required exceptions have been addressed.
How are deviations handled during batch execution?
Deviations can be reviewed and dispositioned with the originating batch record and relevant execution context available for review. When further investigation is required, the deviation can be escalated into the appropriate Quality process.
Can data from an electronic batch record connect to other systems?
Batch data can support downstream workflows through configured connections. We confirm the required connection, data mapping, and implementation scope for your systems during setup.