AmpleLogic Audit Management
amplelogic.com
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; 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.
Spec sheet
- Purpose
- The software supports planning, execution, and closure of audits using structured checklists, findings management, action tracking, and audit history.Read 5 Oct 2026 · amplelogic.com
- Audience
- The audit module is presented for pharmaceutical quality systems and its use cases include pharma, biotech, and medical devices.Read 5 Oct 2026 · amplelogic.com
- 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.Read 5 Oct 2026 · amplelogic.com
- 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.Read 5 Oct 2026 · amplelogic.com
- Headquarters
- Hyderabad, Telangana, IndiaRead 28 Sep 2026 · amplelogic.com
- Founded
- 2010Read 28 Sep 2026 · amplelogic.com
- Audit records
- The product maintains centralized audit records and audit history, with trend reporting and visibility into open findings.Read 5 Oct 2026 · amplelogic.com
- Audit types
- The product supports internal, supplier, third-party, external, and regulatory inspection readiness workflows.Read 5 Oct 2026 · amplelogic.com
- Audit workflow
- The workflow covers audit planning, scheduling, preparation, execution, findings, corrective actions, review, and closure.Read 5 Oct 2026 · amplelogic.com
- Checklists
- Auditors can prepare checklists and documents, and the product lists auditor assignment and checklist management as capabilities.Read 5 Oct 2026 · amplelogic.com
- 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.Read 5 Oct 2026 · amplelogic.com
- Controls
- The page describes audit trails, electronic signatures, role-based access, traceability, controlled workflows, and version control as controls supporting regulated quality operations.Read 5 Oct 2026 · amplelogic.com
- eQMS links
- Audit records can link to CAPA and deviation records, and the module is described as connecting with related eQMS modules.Read 5 Oct 2026 · amplelogic.com
- Findings and actions
- Users can classify findings and observations, assign corrective actions, and track responses through review and closure.Read 5 Oct 2026 · amplelogic.com
- Platform
- The broader eQMS platform is described as cloud-based SaaS and lists mobile quality execution among its platform features.Read 5 Oct 2026 · amplelogic.com
- Support and sales
- The product page offers a scheduled demo and brochure request; it lists AmpleLogic contact details and a toll-free number.Read 5 Oct 2026 · amplelogic.com
Plans and prices
Strong points and limits
Strong points
- Covers planning through audit closure
- Supports several audit types and inspection readiness
- Links audit records to CAPA and deviation records
- Includes audit trails and electronic signatures
- Provides trend reporting and open-finding visibility
Limits
- Pricing is available on request only
- Listed controls alone do not guarantee regulatory compliance
Who it suits
It is presented for pharmaceutical quality systems, with use cases in pharma, biotech, and medical devices. It suits teams that need structured audit workflows and links to related quality records.
Verdict
The module covers audit workflows, findings, corrective actions, and related quality records, with controls intended for regulated operations. Its compliance labels should not be read as a guarantee that use of the listed controls alone ensures compliance.
Where Specifiction places it
- Audit Management Software#11 of 327.6