AmpleLogic Audit Management vs OpenWorkpaper

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.

OpenWorkpaper is an open-source web application for documenting audits from planning through fieldwork and reporting. Its task dashboard lists active audits, assigned procedures, and pending reviews. A centralized request area handles client information requests and master PBC spreadsheet uploads and downloads. Procedures can record purpose, source, scope, methodology, results, conclusions, and reviewer comments, with PDF, Word, Excel, and PowerPoint attachments. Audit programs export to Word, and automatic numbering organizes groups, procedures, and attachments hierarchically. Collaboration includes assignments, team management, discussions, and preparer and reviewer sign-offs. Role-based access combines system roles with audit-specific teams. OpenID Connect works with Microsoft Entra ID, Okta, and Keycloak. The project documents HTTPS through Nginx and SSL/TLS certificates and records sensitive actions in audit logs. It supports local, private-network, and cloud deployment with a portable SQLite database. The free open-source plan is free.