AmpleLogic Audit Management vs FlinkISO

AmpleLogic Audit Management is a web-based module for planning, carrying out, and closing audits in pharmaceutical quality systems. Its workflow covers scheduling and preparation through execution, findings, corrective actions, review, and closure. Auditors can manage assignments, checklists, and documents; teams can classify findings, assign actions, and follow responses through review. The product supports internal, supplier, third-party, and external audits, as well as regulatory inspection readiness. Audit records can link to CAPA and deviation records, while centralized history, trend reporting, and visibility into open findings help teams follow activity. Listed controls include audit trails, electronic signatures, role-based access, traceability, controlled workflows, and version control. The product page labels it 21 CFR Part 11 and EU Annex 11 compliant, while noting that the controls alone do not guarantee regulatory compliance. The broader eQMS is described as cloud-based SaaS and includes mobile quality execution. Pricing is on request, and the product page offers a scheduled demo. The stated audience includes pharma, biotech, and medical device use cases.

FlinkISO is open-source quality management software for handling documents, forms, workflows and QMS records. It supports ISO 9001, ISO 14001, ISO 45001 and ISO 13485, with other standards configurable. Document tools include search, retrieval, version control, access restrictions and approval workflows. Users can make HTML forms with drag-and-drop fields, validations, layouts and business rules without coding. Modules cover audits, change control, management reviews, complaints, nonconformities, corrective actions, training, equipment records and calibration. FlinkISO integrates with ONLYOFFICE for document editing and approval, and can connect to cloud OpenAI-compatible providers or self-hosted Ollama for chat and form-building workflows. Install it on Linux or Windows servers, or use the hosted edition. The Free On-Premise plan is free, with no expiry and all QMS modules. On-Cloud QMS and Form Creation API each cost $80 a month; hosted file uploads are limited to 25 MB each. The Startup Plan is $750 as a one-time purchase for a three-month plan.