Managing the Complete C&Q Lifecycle with One Integrated Platform

From C&Q Strategy and Project Validation Master Plans through Construction Handover, IQ, OQ, PQ and Summary Reports, discover how goPLIMS provides a single governed platform for managing the entire Commissioning & Qualification lifecycle in regulated pharmaceutical projects.

Instead of relying on disconnected spreadsheets, email chains and isolated trackers, this case study demonstrates how 11 fully integrated goPLIMS modules create complete visibility, structured workflows, controlled documentation and real-time execution across every phase of pharmaceutical C&Q.

Executive Summary

Commissioning and Qualification (C&Q) is one of the most complex phases of any pharmaceutical capital project, requiring engineering, CQV, quality, validation and project teams to coordinate hundreds of interconnected activities while maintaining regulatory compliance. This case study demonstrates how goPLIMS manages the complete C&Q lifecycle within a single integrated platform, supporting C&Q Strategy, Validation Master Plans, URS, Risk Assessments, Construction Handover, IQ, OQ, PQ, Change Management and project closeout.

Discover how integrated workflows, real-time visibility and governed execution help pharmaceutical teams improve collaboration, strengthen compliance and deliver Commissioning & Qualification projects with confidence.

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Frequently Asked Questions

Is goPLIMS suitable for regulated pharmaceutical environments?

Yes. goPLIMS is purpose-built for regulated industries. ESignM provides 21 CFR Part 11 compliant electronic signatures with a full audit trail of who approved what, when and with what credentials. Every action, document revision, deviation, change and decision is timestamped and retained — giving C&Q teams an inspection-ready record across the entire project lifecycle.

How does goPLIMS replace Excel-based URS and Risk Assessment trackers?

goPLIMS keeps the flexibility teams already rely on in Excel — URS and System Risk Assessment documents are still created and edited in Excel format — while TrackR adds the version control, access control and centralised Systems List and Systems Classification that spreadsheets alone cannot provide. The Requirements Traceability Matrix (RTM) is built directly from the URS structure, giving live traceability from requirement through to DQ, SAT, IQ and OQ closure.

What is the typical cost saving from moving to goPLIMS?

Based on a 15-member C&Q team, traditional spreadsheet-based coordination costs an estimated €86,400 per month, versus €46,200 per month with goPLIMS — including licensing for 30 users at €100/user/month. That is a projected monthly saving of around €40,200, or roughly €482,400 per year, driven primarily by reduced meeting time and coordination overhead. Actual savings will vary by team size and project complexity.

How quickly can a C&Q team get started with goPLIMS?

goPLIMS is a cloud-based platform with no software installation required — teams access it through any major web browser, with a companion mobile app for on-site updates. Streams, workstreams and access permissions can be configured around your existing C&Q structure (Design, Construction, Equipment, Process, Procurement, etc.), so most project teams can be onboarded and actively logging actions within days. Contact us to arrange a demo tailored to your project’s specific streams and requirements.

Can goPLIMS manage the full C&Q lifecycle, or only specific phases?

goPLIMS manages the complete C&Q lifecycle from a single platform — starting with C&Q Strategy, the Project Validation Master Plan and the Project Quality Management System (PQMS), through URS, Design Qualification and System Risk Assessment, into Construction handover, and on to IQ, OQ and PQ protocol execution, deviation and change management, and final Summary Report issuance. Every phase uses the same 11 integrated modules under one sign-on, so data, decisions and documents carry forward without re-entry or duplication.