Pharma Commissioning

Standardising Execution for Pharma Commissioning with goPLIMS

Executive Summary

Commissioning and qualification delays can derail product launch timelines and regulatory readiness
Teams rely on paper forms, Excel trackers, and siloed sytems slowing execution and increasing audit risk
Compliance data is fragmented across disciplines, making traceability and deviation control difficult
No unified platform for execution, documentation, and close-out-leading to inefficiencies and rework

Business Challenge

Paper-based inspections and commissioning forms
Disconnected workflows across CQV, engineering, and validation
Manual RFI and deviation tracking
Limited real-time visibility for project leads & QA A High documentation burden for audit readiness

The goPLIMS Solution

Unified commissioning execution platform
Digital forms with structured workflows and mobile capture
Built-in compliance logic and audit trails
Real-time dashboards for CQV leads, QA, & clients Configurable modules for pharma workflows and validation protocols

goPLIMS Modules

FormM – Digital inspections, commissioning, and qualification forms

ChangeM / DeviateM – Structured change control and deviation tracking with full audit history

RFI-M – Request for Information workflows with searchable archive

EDocM + E-SignM – Controlled documents and digital approvals

ChangeM / DiscrepM – Change management & exception management with e-signatures

DecisionM – Structured decision logging with rationale, approvals, and audit trail

TrackR – Live trackers & dashboards for construction, commissioning, and turnover

Key Outcomes

Decision Cycle Time

Decision Traceability

Team’s coordination

Digital management systems

Reduced by 20-30%

100% audit-ready

Seamless

75% faster