GMP Engineering & Qualification
Capital Project Management
Govern your GMP capital projects from design concept to manufacturing readiness
From design milestones and GMP change management through construction punchlist, commissioning, IQ/OQ/PQ qualification, and manufacturing readiness sign-off — one governed, 21 CFR Part 11 compliant platform replacing spread sheets, disconnected tools and Word change requests.
Dedicated pharma cloud | Punchlist & change management built-in | Purpose-built for pharma | From groundbreak to PAI-ready
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GMP capital projects are run on MS Project, email, and Word — tools that produce no inspection-ready qualification record
Delivering a GMP facility or major equipment project on time and in compliance requires simultaneously governing design milestones, contractor punchlist items, GMP change requests, commissioning actions, and IQ/OQ/PQ qualification documentation — across project managers, engineering teams, contractors, QA, and regulatory affairs. Most pharma capital project teams do this with MS Project for milestones, Excel for punchlist, Word for change requests, and email for everything else.
The result is qualification delays, FDA and EMA inspectors finding incomplete change registers and unresolved punchlist items during PAI, and C&Q document packages assembled manually from files scattered across shared drives — each a potential data integrity finding.
- Excel punchlist trackers updated manually by site and contractor teams
- Word change request forms with no electronic approval workflow
- Email chains to coordinate contractors and QA on punchlist closures
- Shared drives for C&Q protocols with no version control or access trail
- MS Project disconnected from QA, qualification, and regulatory teams
A governed GMP capital project platform where design milestones, construction punchlist, change management, commissioning actions, and IQ/OQ/PQ documentation are all managed in one compliant system — producing the inspection-ready qualification record as the project runs, not after it ends.
End-to-end governance from design approval through manufacturing readiness
goPLIMS governs every phase of the GMP capital project — from URS and design review through construction, GMP change control, commissioning, IQ/OQ/PQ, and the formal manufacturing readiness sign-off that releases the facility for first commercial manufacture
Real GMP capital project scenarios governed by goPLIMS
From greenfield facility builds to equipment installations — goPLIMS is configured for the real-world governance complexity of GMP capital project delivery in pharma.
Greenfield Facility
New oral solid dosage GMP facility — from FEL through commercial manufacturing readiness
A mid-size pharma company builds a new OSD facility. goPLIMS governs the complete project — design review actions tracked in ActionR, construction punchlist managed in PunchM by discipline and GMP criticality, all design changes governed through ChangeM with QA approval and e-signed closure, IQ/OQ/PQ protocols reviewed and approved in EDocM, and the manufacturing readiness review formally signed off in goPLIMS — the entire project record inspection-ready on day one of PAI.
Sterile Manufacturing
New fill-finish line installation in an existing sterile manufacturing facility
A biologics CDMO installs a new isolator-based fill-finish line within an existing classified suite. goPLIMS governs the GMP change request for the facility modification, the construction and cleanroom punchlist, commissioning of the isolator and RABS systems, and the IQ/OQ/PQ qualification programme — with the sponsor given controlled access to review qualification protocols and reports as they are approved, in real time.
API Manufacturing
API manufacturing suite upgrade — new reactor installation through process qualification
A chemical API manufacturer replaces three batch reactors with a continuous flow reactor system. goPLIMS governs the project from FEL design review through construction punchlist, GMP change management for the process parameter changes, reactor commissioning, equipment qualification, and process qualification — linking the qualification package directly to the regulatory submission CMC variation for the updated manufacturing process.
Equipment Qualification
GMP equipment qualification programme for 12 new analytical instruments across two sites
A pharma quality team qualifies 12 new HPLC and dissolution systems across two manufacturing sites simultaneously. goPLIMS manages the qualification programme as one workstream per site — IQ, OQ, PQ protocols & reports issued, and reports approved in EDocM with ESignM — with the QA monitoring qualification completion status across all instruments and both sites from one TrackR dashboard.
The goPLIMS modules powering GMP capital project management
Six purpose-built modules — including dedicated punchlist and change management functions — working together on one dedicated, 21 CFR Part 11 compliant cloud from design through manufacturing readiness.
PunchM · ActionR
Punchlist & Action Management
Construction and commissioning punchlist items managed by discipline, contractor, and GMP criticality — each item assigned, deadline set, and closed with e-signed confirmation. The governed punchlist closure record that GMP inspectors review during PAI.
EDocM
Electronic Document Management
A governed repository for all capital project and qualification documents — URS, design packages, IQ/OQ/PQ protocols and reports, deviation records, and manufacturing readiness review packs — version-controlled, searchable, and linked to approval workflows.
ESignM
Electronic Signature Management
21 CFR Part 11 and EU Annex 11 compliant electronic signatures on every qualification protocol approval, change request closure, and manufacturing readiness sign-off — timestamped, tamper-evident, and exported as part of the PAI qualification package.
ChangeM
GMP Change Management
Every design change and scope modification managed as a formal change request — GMP impact assessment, review chain, QA approval, implementation actions, and e-signed closure. The compliant, timestamped change register that defines the qualification basis.
TrackR
Central Online Tracker
A live capital project dashboard — design milestone completion, punchlist closure rate, change register status, qualification protocol approval progress, and manufacturing readiness score — updated in real time as the project progresses across all teams and contractors.
FormM
Form Management
All standard project checklists authored as structured electronic forms — version-controlled, executed with structured data entry and in-situ observation recording, and approved with 21 CFR Part 11 compliant e-signatures. All forms built for inspection from the start.
GMP capital project records that satisfy FDA and EMA inspection requirements
Every design change, punchlist closure, and qualification record in goPLIMS is governed by data integrity controls that meet the standards regulators apply during pre-approval inspections — so your project record is inspection-ready throughout the project, not assembled at the end.
21 CFR Part 11 e-signed qualification records
Every IQ, OQ, and PQ protocol approval, deviation closure, and manufacturing readiness sign-off is executed with a timestamped, intent-captured electronic signature — producing qualification records that meet FDA and EMA requirements from the moment they are created.
Tamper-evident change and punchlist audit trail
Every change request, punchlist item, and qualification action is captured in an immutable, timestamped audit trail. When an inspector asks what changed from the design intent and why, the complete, unalterable record is in goPLIMS — not in someone’s email archive.
Controlled contractor and engineer access
Contractors, engineering firms, and commissioning agents access only the punchlist items, documents, and actions assigned to them — enforced by role-based permissions, with every access and action logged in the audit trail. No over-sharing of GMP design documents or confidential process information.
Single-tenant dedicated pharma cloud
Your GMP facility designs, qualification protocols, and project data are never co-mingled with other pharma companies or industries. A dedicated cloud instance with dedicated storage meeting the data security requirements applicable to pharmaceutical manufacturing site records.
Long-term record retention and encryption
All capital project and qualification records retained for the GMP-required period — encrypted at rest and in transit, with automated backup ensuring the complete project record and qualification package are always available for post-approval inspections or lifecycle management submissions.
ALCOA+ enforced on all project records
All project records — punchlist closures, change requests, qualification data — are Attributable, Legible, Contemporaneous, Original, and Accurate, enforced by system architecture at the point of entry. No backdating, no unattributed changes, no altered records — by design, not by policy.
From live punchlist status to a complete PAI-ready qualification package
goPLIMS gives project managers, QA directors, and regulatory affairs teams the visibility they need throughout the capital project — and automatically produces the qualification record the regulatory submission and PAI inspection require.
Capital Project Milestone Dashboard
Punchlist Status Report by Discipline
GMP Change Register
C&Q Document Completion Report
Manufacturing Readiness Score
PAI Qualification Package Export
Purpose-built for GMP capital projects — not generic construction management
Generic construction project management tools manage schedules and costs. goPLIMS manages GMP compliance — punchlist closure records that satisfy PAI inspectors, change registers that define the qualification basis, and qualification documents that are compliant from the moment they are created.
Single dedicated cloud
Your GMP facility designs, process data, and qualification records are never shared with other companies or industries. Dedicated infrastructure meeting the data security requirements for pharmaceutical manufacturing site records.
21 CFR Part 11 by design
Compliance is the architecture. Qualification records, change registers, and punchlist closures are governed by 21 CFR Part 11 compliant electronic records and e-signatures — producing the PAI-ready project record automatically, as the project runs.
Connected to regulatory submission
Qualification documents approved in goPLIMS during the capital project feed directly into the facility and manufacturing sections of the regulatory submission on the same platform — no file migration, no manual document collection before PAI..
Live in days, not months
Configured to your project — your facility systems, your contractor roles, your qualification protocol structure — and productive from day one. No lengthy IT implementation before your project team and contractors can start working in a governed environment.
Your questions answered.
Construction and commissioning punchlist items are managed in goPLIMS as governed actions — each item assigned to a responsible contractor or engineering discipline, categorised by GMP criticality, given a closure deadline, and tracked in real time on a punchlist dashboard. Items are closed with e-signed confirmation, and the punchlist closure record is retained as an inspection-ready qualification document — exactly what FDA and EMA inspectors review during PAI when assessing the commissioning basis for qualification.
Every design or scope change during a GMP capital project is managed as a governed change request — initiated with a GMP impact assessment, reviewed through a controlled approval workflow, implemented with supporting documents in EDocM, and closed with a 21 CFR Part 11 compliant e-signature. The change register in goPLIMS provides a timestamped, tamper-evident record of every change made to the GMP facility or equipment, which is exactly what regulators review when assessing the qualification basis at PAI.
Yes. External contractors, engineering firms, and commissioning agents are given controlled, role-based access to their specific project workstreams — punchlist items assigned to them, documents they need to review, and actions for which they are responsible. All contractor activity is logged in a complete audit trail. Contractors have no access to other projects, financial data, or confidential GMP documentation outside their scope of work.
The capital project programme in goPLIMS runs on the same platform as the tech transfer and regulatory submission workstreams. Qualification documents approved in EDocM during the capital project feed directly into the manufacturing and facility sections of the regulatory submission package — the same governed document store, the same audit trail. When the manufacturing readiness review is completed and e-signed in goPLIMS, the full qualification package is already available to the regulatory team without any document migration or manual collection.
Ready to govern your GMP capital project from design through manufacturing readiness?
See how goPLIMS replaces Excel punchlists, Word change forms, and shared drive C&Q folders with one governed, PAI-ready capital project platform — purpose-built for pharma.