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AmpleLogic Audit Management
Hyderabad, Telangana, India
What it is
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, while teams classify findings, assign actions, and track 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, and centralized history, trend reporting, and visibility into open findings support follow-up. Listed controls include audit trails, electronic signatures, role-based access, traceability, controlled workflows, and version control. The product page labels the software 21 CFR Part 11 and EU Annex 11 compliant, while cautioning that the controls alone do not ensure regulatory compliance. The broader eQMS platform is described as cloud-based SaaS and includes mobile quality execution. Pricing is on request, and the product page offers a scheduled demo.
For and against
For
- Covers audit planning through closure.
- Links audit records to CAPA and deviation records.
- Tracks open findings and audit history.
- Lists electronic signatures and role-based access.
- Includes trend reporting.
Against
- Pricing is available on request.
- The module is listed for web.
- Listed controls alone do not guarantee compliance.
The verdict
AmpleLogic Audit Management supports audit workflows, findings follow-up, and quality-system records. Buyers should note the compliance caveat and request pricing or a demo for details.
Who it suits
The audit module is presented for pharmaceutical quality systems, with use cases in pharma, biotech, and medical devices.
Plans and prices
AmpleLogic Audit Management
Pricing not stated; schedule a demo
Read 5 Oct 2026 · amplelogic.com
On the record
- Audience
- The audit module is presented for pharmaceutical quality systems and its use cases include pharma, biotech, and medical devices.amplelogic.com · read 5 Oct 2026
- Audit records
- The product maintains centralized audit records and audit history, with trend reporting and visibility into open findings.amplelogic.com · read 5 Oct 2026
- Audit types
- The product supports internal, supplier, third-party, external, and regulatory inspection readiness workflows.amplelogic.com · read 5 Oct 2026
- Audit workflow
- The workflow covers audit planning, scheduling, preparation, execution, findings, corrective actions, review, and closure.amplelogic.com · read 5 Oct 2026
- Checklists
- Auditors can prepare checklists and documents, and the product lists auditor assignment and checklist management as capabilities.amplelogic.com · read 5 Oct 2026
- Compliance caveat
- The product page labels the software 21 CFR Part 11 and EU Annex 11 compliant, while noting that its listed controls alone do not guarantee regulatory compliance.amplelogic.com · read 5 Oct 2026
- Controls
- The page describes audit trails, electronic signatures, role-based access, traceability, controlled workflows, and version control as controls supporting regulated quality operations.amplelogic.com · read 5 Oct 2026
- eQMS links
- Audit records can link to CAPA and deviation records, and the module is described as connecting with related eQMS modules.amplelogic.com · read 5 Oct 2026
- Findings and actions
- Users can classify findings and observations, assign corrective actions, and track responses through review and closure.amplelogic.com · read 5 Oct 2026
- Integrations
- The broader eQMS integration hub lists connections to DMS, LMS, LIMS, eBMR/MES, RIMS, cleaning validation, eLogbook, safety/pharmacovigilance, and ERP/supply chain systems.amplelogic.com · read 5 Oct 2026
- Platform
- The broader eQMS platform is described as cloud-based SaaS and lists mobile quality execution among its platform features.amplelogic.com · read 5 Oct 2026
- Purpose
- The software supports planning, execution, and closure of audits using structured checklists, findings management, action tracking, and audit history.amplelogic.com · read 5 Oct 2026
- Security
- AmpleLogic's privacy policy says its security measures include encryption in transit and at rest, access controls, regular security audits, and compliance with ISO 27001 and SOC 2 Type II standards.amplelogic.com · read 5 Oct 2026
- Support and sales
- The product page offers a scheduled demo and brochure request; it lists AmpleLogic contact details and a toll-free number.amplelogic.com · read 5 Oct 2026
