End-to-end audit governance
Pharma Audit Management
Govern every phase of your pharma audit programme
From audit planning and scheduling through execution, findings management, CAPA tracking, and close-out — one governed, 21 CFR Part 11 compliant platform replacing every disconnected spreadsheet and email chain.
Dedicated pharma cloud | Purpose-built for pharma | Real-time audit visibility
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Most pharma audit programmes run on tools never designed for GMP compliance
GMP audits are among the most critical and high-risk activities in pharmaceutical operations — yet many teams still manage audits using spreadsheets, email chains, and disconnected shared drives.
Without governed workflows, real-time visibility, and compliant audit trails, teams struggle to effectively manage findings, CAPAs, and audit readiness across the organisation.
No Centralised Audit Management
Audit schedules, findings, CAPAs, and supporting documents are often managed across separate spreadsheets, emails, and folders.
Without a single source of truth, teams struggle to maintain accurate and real-time audit oversight.
Limited Visibility & CAPA Tracking
Most audit teams lack live visibility into open findings, overdue CAPAs, ownership status, and remediation progress.
As audit programmes grow, manual tracking creates delays, missed deadlines, and inconsistent follow-up activities.
Disconnected Workflows & Collaboration
Audit execution, CAPA management, approvals, and signatures are frequently handled across disconnected systems with limited coordination.
This creates communication gaps, duplicate effort, and inefficient collaboration between QA teams, site operations, and auditors.
Compliance & Knowledge Retention Risks
Audit history, corrective actions, and regulatory inspection knowledge are often lost when auditors or QA personnel leave the organisation.
Without governed workflows, version control, and audit-ready records, organisations increase the risk of repeat findings and compliance gaps.
goPLIMS closes the gap
goPLIMS provides one governed platform for pharma audit management — bringing audits, findings, CAPAs, approvals, signatures, and reporting into a single compliant system.
A single source of truth for audit visibility, collaboration, accountability, and GMP-compliant execution.
End-to-end governance across your audit lifecycle
goPLIMS governs every phase of the pharma audit workflow — from programme planning and audit scheduling through execution, findings management, CAPA remediation, and formal close-out.
Real audit scenarios governed by goPLIMS
From annual GMP programmes to pre-approval inspection readiness — goPLIMS is configured for the real-world complexity of pharma audit management.
Supplier qualification
Annual CDMO and CMO GMP audit programme — multi-site, multi-supplier
A mid-size pharma company manages its annual 12-audit supplier qualification programme in goPLIMS — scheduling, executing, and closing audits across CDMOs, contract laboratories, and API manufacturers with a single CAPA register and audit trail.
Inspection readiness
FDA pre-approval inspection (PAI) readiness review for new drug product
A regulatory affairs and QA team uses goPLIMS to run a structured PAI readiness audit against the expected inspection scope — identifying gaps, assigning remediation actions, and producing an inspection-ready programme summary exportable for the health authority.
Internal GMP programme
Annual internal GMP audit programme across three manufacturing sites
A global pharma manufacturer runs its internal GMP audit programme across three sites — one platform for all audit plans, FormM checklists, findings, CAPAs, and close-outs — with a real-time dashboard for the QA Director showing programme status across all sites simultaneously.
Third-party compliance
GLP contract laboratory qualification and ongoing surveillance audit
A clinical development team qualifies a new GLP contract laboratory using goPLIMS — running the qualification audit, issuing findings, tracking CAPAs, and scheduling follow-up surveillance audits — all within the same governed platform, with the laboratory accessing only their own audit records.
The goPLIMS modules powering pharma audit management
Six purpose-built modules working together on one dedicated, 21 CFR Part 11 compliant cloud. Each shares the same audit trail, document store, and access controls — across your entire audit programme.
ActionR
Action Register Management
Assign, track, and escalate every audit finding and CAPA action — with owner accountability, deadline management, and real-time status visibility across the full team and auditees.
EDocM
Electronic Document Management
A single governed repository for all audit documentation — audit plans, reports, CAPA evidence, and supporting records — version-controlled, searchable, and linked to the approval workflow.
ESignM
Electronic Signature Management
21 CFR Part 11 and EU Annex 11 compliant electronic signatures — timestamped, tamper-evident records on every audit report approval, CAPA sign-off, and effectiveness review action.
FormM
Electronic Form Management
Govern audit checklists, observation records, and audit reports as structured electronic forms — version-controlled, role-restricted, and signed off with 21 CFR Part 11 compliant e-signatures.
TrackR
Central Online Tracker
A live audit programme dashboard showing status, CAPA completion, overdue actions, and upcoming audits — updated in real time, not manually refreshed from a spreadsheet.
DecisionM
Decision Management
Record every audit programme decision — scope changes, risk-based scheduling rationale, and lessons learned — so institutional knowledge is retained in the platform, not lost when auditors leave.
GMP-compliant audit records — secure, immutable, inspection-ready
Every audit record in goPLIMS is not just stored — it is governed. The platform enforces data integrity and security controls that meet the requirements a health authority inspector will look for on the day they arrive.
21 CFR Part 11 compliant e-signatures
Every audit report approval, CAPA sign-off, and close-out certificate is signed with a timestamped, intent-captured electronic signature — meeting FDA requirements for authenticity and non-repudiation.
Immutable, timestamped audit trail
Every create, update, and delete action across the audit programme is recorded with user identity, timestamp, and reason — immutable and exportable as a compliant audit trail for health authority review.
Role-based access and segregation of duties
Auditors, auditees, CAPA owners, and QA directors each see only what their role permits. Segregation of duties — e.g. the auditor cannot close their own CAPA — is enforced by the platform architecture.
Single-tenant dedicated pharma cloud
Your audit records and CAPA data are never co-mingled with other organisations. A dedicated cloud instance with dedicated storage and access controls — meeting GMP data security requirements.
Data encryption and disaster recovery
All audit data is encrypted at rest and in transit. Automated backup and recovery procedures meet GMP data availability and disaster recovery requirements under applicable regulations.
ALCOA+ enforced by system architecture
All audit records are Attributable (user-identified), Legible (searchable), Contemporaneous (timestamped at entry), Original (tamper-evident), and Accurate — enforced by the platform, not by user discipline.
From live programme status to inspection-ready audit records
goPLIMS generates the reports your QA Director, auditors, and inspectors need — automatically, in real time, without someone manually compiling a status update from five different spreadsheets.
Audit Programme Status Dashboard
CAPA Status & Overdue Report
Finding Trend Analysis
Audit Close-out Certificate
Inspection Readiness Export
Annual Audit Programme Completion Report
Compliance without the enterprise price tag
goPLIMS was designed from the ground up for regulated pharma — not adapted from a generic tool. Small and mid-size teams get the same governance capability as enterprise QMS platforms, without the complexity or cost.
Single dedicated cloud
Your pharma data is never shared with other industries or tenants. A dedicated deployment meeting GMP data integrity and data security requirements throughout.
21 CFR Part 11 by design
Compliance is the architecture, not a feature. Electronic records, e-signatures, and audit trails are built into every module from the ground up — not bolted on.
One integrated platform
The same platform that governs your regulatory submissions, pre-manufacturing phases, and knowledge management — sharing one audit trail, document store, and dedicated cloud.
Live in days, not months
No lengthy implementation project. Configured to your audit programme structure and productive from day one — with onboarding support included.
Your questions answered.
goPLIMS governs every phase in sequence on one platform. Audit programmes are built in ActionR and TrackR, individual audits executed using FormM electronic checklists, findings issued through EDocM with ESignM approval, CAPAs tracked in ActionR with escalation and effectiveness checks, and the audit formally closed with tamper-evident sign-off. Everything is linked — the planning record, execution evidence, report, and CAPA — in one complete audit trail.
Yes. goPLIMS supports all audit types within a single programme — internal GMP audits, supplier qualification and surveillance audits, contract manufacturer audits, and regulatory inspection readiness reviews. Each audit has its own scope, checklist, findings register, and CAPA register, while all share the same governed platform and audit trail.
TrackR provides a real-time dashboard of all audits, CAPA status, and overdue actions — exactly the kind of programme summary an inspector expects to see. Every finding, corrective action, and closure decision has a complete, timestamped, tamper-evident audit trail meeting 21 CFR Part 11 and EU Annex 11 requirements and exportable for inspection on demand.
Most teams are live within days. goPLIMS is configured to your audit programme structure — your audit types, your team roles, your CAPA classification scheme. There is no lengthy IT infrastructure to provision and no implementation project. Book a Pharma Demo and we will show you how it works for a team and programme exactly like yours.
Ready to govern every phase of your pharma audit programme?
See how goPLIMS replaces Excel trackers and disconnected audit tools with one compliant, governed platform — purpose-built for pharma teams of every size.