AmpleLogic Audit Management
AmpleLogic Audit Management is a web-based audit module for pharmaceutical quality systems.
What AmpleLogic Audit Management is
AmpleLogic Audit Management is a web-based audit module for pharmaceutical quality systems. It supports audit planning, scheduling, preparation, execution, findings, corrective actions, review, and closure. Teams can manage auditor assignments, checklists, and documents, then classify findings and observations, assign corrective actions, and follow responses through review. Supported workflows include internal, supplier, third-party, and external audits, as well as regulatory inspection readiness. Audit records can link to CAPA and deviation records; centralized history, trend reporting, and visibility into open findings help organize 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 noting that listed controls alone do not guarantee regulatory compliance. Pricing is on request. The broader eQMS is described as cloud-based SaaS with mobile quality execution.
Good
- Covers planning through audit closure.
- Supports internal, supplier, third-party, and external audits.
- Links audit records to CAPA and deviations.
- Includes trend reporting and open-finding visibility.
- Lists role-based access and electronic signatures.
Watch out
- Pricing is available on request.
- Listed controls alone do not guarantee regulatory compliance.
Who it suits
It suits pharma, biotech, and medical-device teams coordinating regulated audits and follow-up actions. It is also relevant to organizations linking audit work with CAPA and deviation records.
Verdict
AmpleLogic Audit Management brings audit scheduling, findings, actions, and records into a quality-system workflow. Teams should assess its regulatory controls within their own compliance requirements.
Plans and prices
From AmpleLogic Audit Management's own pricing page, checked 5 Oct 2026.
| Plan | Price | What it gives you |
|---|---|---|
| AmpleLogic Audit Management | Priced on request | Pricing not stated; schedule a demo |
The facts
Each one read from AmpleLogic Audit Management's own pages, with the date it was checked.
What it does
- Audience
- The audit module is presented for pharmaceutical quality systems and its use cases include pharma, biotech, and medical devices.checked 5 Oct 2026
- Audit records
- The product maintains centralized audit records and audit history, with trend reporting and visibility into open findings.checked 5 Oct 2026
- Audit types
- The product supports internal, supplier, third-party, external, and regulatory inspection readiness workflows.checked 5 Oct 2026
- Audit workflow
- The workflow covers audit planning, scheduling, preparation, execution, findings, corrective actions, review, and closure.checked 5 Oct 2026
- Checklists
- Auditors can prepare checklists and documents, and the product lists auditor assignment and checklist management as capabilities.checked 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.checked 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.checked 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.checked 5 Oct 2026
- Findings and actions
- Users can classify findings and observations, assign corrective actions, and track responses through review and closure.checked 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.checked 5 Oct 2026
- Purpose
- The software supports planning, execution, and closure of audits using structured checklists, findings management, action tracking, and audit history.checked 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.checked 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.checked 5 Oct 2026
The company
- Founded
- 2010checked 28 Sep 2026
- Headquarters
- Hyderabad, Telangana, Indiachecked 28 Sep 2026
Where it runs
- Platform
- The broader eQMS platform is described as cloud-based SaaS and lists mobile quality execution among its platform features.checked 5 Oct 2026
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