Manufacturing
Manufacturing Records
For Production and Quality
Manage electronic batch records, manufacturing calculations, and certificates of analysis with software configured around your production processes.
Your Manufacturing Records, Connected.
Electronic Batch Records
Build Batch Records
Around Your Process.
Create master batch record templates that reflect your manufacturing process, with the steps, required inputs, and controls your team needs during execution.
Structured templates
Organize records by unit procedures, operations, and phases.
Required inputs
Define what information must be captured throughout execution.
Reusable records
Start each batch from a controlled master record template.
Process-specific setup
Configure records around the way your product is manufactured.
Batch Execution
Follow Production
as Work Is Completed.
Track each lot as work progresses through the batch record, with status, completion, and required Quality review visible in one place.
Live progress
See how far each batch has progressed through its phases.
Execution status
See which records are in progress or ready for review.
Quality review
Bring Quality into the record when review or approval is required.
Review by exception
Set thresholds and automatically flag information that needs attention.
Connected Quality
Keep Deviations With
Their Batch Record.
Capture deviations where they occur, manage review and disposition, and escalate issues into the QMS when they require further investigation.
Batch context
Keep each deviation tied to its originating batch record.
Point of detection
Capture where in the record or process the issue occurred.
Review & disposition
Classify, review, and document how each deviation is handled.
QMS escalation
Move deviations into nonconformances when further action is required.
Explore Cytodyme Manufacturing
Choose the solution your team needs today, with every record, workflow, and decision connected in one controlled system.
Electronic Batch Records
Build and execute controlled batch records, track progress, and manage deviations throughout production.
Validated Calculations
Test, review, approve, and lock reusable calculations for batch records and other configured workflows.
Certificate of Analysis
Prepare CoAs in two minutes, with source references to help your team verify the results.
Still Have Questions?
Still have questions? We’ve got you covered.
If it’s not covered here, reach out or book a demo to see Cytodyme in action.
Can Cytodyme’s electronic batch records be configured around our manufacturing process?
Yes. Electronic batch record templates can be configured around your manufacturing process, including the structure of the record, required inputs, and individual steps. Cytodyme supports records organized by unit procedures, operations, and phases, with granular configuration at the input level.
How does Quality review and approve work during batch execution?
Quality can view batch progress as work is being completed and participate in review and approval when required. Access can also be controlled so the appropriate people perform or review specific activities during execution.
How does Cytodyme connect Manufacturing with the QMS?
Batch Records and the QMS can work together while remaining separate parts of the platform. Deviations captured during batch execution can be escalated into nonconformances when further Quality action is required, keeping the manufacturing issue connected to the Quality process.
Can Cytodyme integrate with our ERP or other manufacturing systems?
Yes. Cytodyme supports integrations with other systems, including ERP workflows. Integrations can be configured around the systems and information involved in the customer’s manufacturing process.
How does Cytodyme support compliance, validation, and electronic records?
Cytodyme provides controlled access, review and approval workflows, and traceability for regulated work. The platform is designed to support compliant electronic workflows while keeping required review and decisions with the appropriate people.