Manufacturing

Simploud for Manufacturing is a cloud-based quality management platform designed for regulated manufacturing environments, including producers of small-molecule APIs, biologics, and medical devices. Rather than treating compliance as a documentation exercise, Simploud connects materials, batch records, and quality events into a single, traceable system that keeps manufacturing, quality, compliance, and supply chain teams working from one unified source of truth.

The platform is built around the principle that manufacturing should be a fully integrated node in a GxP ecosystem — not an isolated set of disconnected tasks. Simploud's many-to-many process and record modelling means a single batch can be linked to multiple materials, multiple deviations, and multiple CAPAs, all visualized and actionable across functions.

Material-Centric Management

• Manage materials as living objects, tracking usage, quantities, and related quality events such as deviations, out-of-specification (OOS) results, and nonconformances
• Assign quality attributes to each material for structured oversight
• Link raw materials to test results, vendors, and certificates of analysis
• Connect materials to supplier records, training requirements, and their full lifecycle risk profile
• Flag critical-to-quality (CtQ) materials for elevated monitoring and control

Batch Manufacturing Execution

• Trigger batch manufacturing activities directly from the material object or from related processes such as change controls, work instructions, or planned demand
• Define and execute batch records electronically within a structured, compliant workflow
• Link batch execution to equipment, personnel training records, and SOPs
• Capture in-process data, deviations, and CAPAs within the context of the batch record
• Maintain full audit trails and 21 CFR Part 11-compliant electronic signatures throughout batch execution

Device History Records (DHRs)

• Handle Device History Records as native platform entities, not add-on modules, for medical device and diagnostic manufacturers
• Connect each DHR to the originating design history, bill of materials, training logs, validations, and production events
• Track all components used in device builds with full traceability
• Link QC tests, labels, calibrations, and nonconformances directly to the DHR
• Ensure inspection readiness for FDA, ISO, or MDR audits at any point in time

Simploud is a secured, scalable, and compliance-ready platform serving a broad range of life sciences industries including biotechnology, pharmaceutical, medical device, CDMO/CMO/CRO, digital health, and laboratory sectors. A free 15-day trial is available for organizations to evaluate the platform against their own specific use cases.