Product development through manufacturing readiness
Pre-Manufacturing Phases
One platform for every phase before manufacturing begins
From product development through clinical trials, tech transfer, and capital project management — goPLIMS governs every pre-manufacturing workstream on one dedicated, and compliant platform.
Dedicated pharma cloud | Purpose-built for pharma | Real-time cross-phase visibility
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21 CFR
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Pre-manufacturing phases are the hardest to manage — and the highest risk
Product development, clinical trials, technology transfer, and capital projects are managed by different teams using different tools, processes, and workflows.
Without a single source of truth, organisations struggle to maintain visibility, retain knowledge, and ensure seamless transitions from development through manufacturing readiness.
No Single Source of Truth
Milestones, actions, documents, and decisions are often managed across separate spreadsheets, emails, shared drives, and project tools.
Without a centralised platform, teams spend valuable time searching for information instead of progressing critical programme activities.
Limited Visibility Across Phases
Each pre-manufacturing phase is typically managed independently, making it difficult to understand overall programme status and readiness.
Leadership teams often lack real-time visibility into risks, delays, dependencies, and progress across the full product journey.
Knowledge Is Lost During Handoffs
Critical decisions, lessons learned, and project context are frequently lost as programmes move between development, clinical, tech transfer, and manufacturing teams.
This creates rework, repeated mistakes, and delays when new teams must rebuild knowledge that already exists elsewhere in the organisation.
Governance & Compliance Gaps Emerge
Disconnected systems make it difficult to maintain consistent workflows, traceability, approvals, and audit readiness across multiple phases.
Issues are often discovered during tech transfer, commissioning, or regulatory review rather than being identified and resolved earlier in the lifecycle.
goPLIMS closes the gap
goPLIMS provides one dedicated platform to govern every pre-manufacturing phase — bringing documents, actions, decisions, milestones, and audit trails into a single compliant environment.
A single source of truth for visibility, collaboration, knowledge retention, and compliant execution from product development through manufacturing readiness.
Dedicated solution pages for each pre-manufacturing phase
Each phase of the pre-manufacturing journey has a dedicated goPLIMS solution page — with phase-specific workflows, module configurations, and use cases. All run on the same integrated platform.
Product Development (R&D Management)
Govern product development and R&D trials by bringing study activities, protocols, materials, tasks, reviews, deviations, and decisions into one governed workspace.
Clinical Trial Management
Manage clinical operations workstreams — trial milestones, site actions, CRO RFI management, and document control with 21 CFR Part 11 compliant e-signatures.
Project Management
Deliver GMP facility and equipment capital projects — design milestones, commissioning actions, punchlist management, change control, and qualification readiness.
End-to-end governance across every pre-manufacturing phase
goPLIMS governs the complete pre-manufacturing journey — from the first product development workstream through clinical operations, technology transfer, and capital project delivery to manufacturing readiness.
Real scenarios governed by goPLIMS across pre-manufacturing
From first-in-human programmes to commercial-scale tech transfer — goPLIMS is configured for the real-world complexity of pharma pre-manufacturing.
R&D → Clinical
IND/CTA filing from lead candidate through Phase I first-in-human
A small-molecule oncology programme manages formulation development, safety studies, and IND preparation on one platform — decisions captured in DecisionM, documents in EDocM, milestones in ActionR — transitioning seamlessly into Phase I site activation.
Clinical → Tech Transfer
Biologic drug substance tech transfer from EU originator to US CDMO
A Phase III biologics programme transfers cell culture, purification, and fill-finish processes to a US contract manufacturer — process documents governed in EDocM, CDMO queries managed as RFIs, and transfer progress tracked in real time via TrackR.
Capital Projects
Greenfield GMP oral solid dosage facility — build through qualification readiness
A mid-size pharma company delivers a new OSD facility using goPLIMS for design milestone management, contractor punchlist tracking, change control, and C&Q documentation — from groundbreak through manufacturing readiness review.
Cross-phase programme
Parallel Phase II–III scale-up with simultaneous CDMO onboarding
A programme running Phase II clinical trials while initiating commercial-scale tech transfer manages both workstreams on the same platform — separate programmes, shared platform, cross-visible milestones, and a single knowledge trail for the submission team that follows.
The goPLIMS modules powering pre-manufacturing phase governance
Six purpose-built modules working together across all four pre-manufacturing phases on one dedicated, 21 CFR Part 11 compliant cloud — sharing one audit trail, document store, and access controls.
ActionR
Action Register Management
Assign, track, and escalate every programme action across development, clinical, tech transfer, and capital project workstreams — with owner accountability and real-time status across all phases.
EDocM
Electronic Document Management
A single governed repository for all pre-manufacturing documents — development reports, clinical protocols, tech transfer packages, and qualification plans — version-controlled and linked to approval workflows.
ESignM
Electronic Signature Management
21 CFR Part 11 and EU Annex 11 compliant electronic signatures on every document approval, protocol sign-off, and tech transfer milestone — timestamped, tamper-evident, and audit-ready.
RFI-M
RFI Management
Manage CRO, CDMO, and supplier queries as governed RFIs — with owner assignment, response deadlines, review chains, and a full audit trail on every response across clinical and tech transfer phases.
TrackR
Central Online Tracker
A live milestone dashboard across all pre-manufacturing workstreams — updated in real time, showing phase progress, action completion, and manufacturing readiness status without manual updates.
DecisionM
Decision Management
Record every development and programme decision — with rationale, alternatives, and outcome — so institutional knowledge is retained in the platform across every phase transition and team change.
Built on GMP data integrity principles from the ground up
goPLIMS is not a generic SaaS tool with compliance bolted on. Every module is engineered to meet pharmaceutical data integrity and security requirements throughout the pre-manufacturing lifecycle.
21 CFR Part 11 compliant e-signatures
Every document approval, protocol sign-off, and milestone acceptance is signed with a timestamped, intent-captured electronic signature — meeting FDA requirements for authenticity and non-repudiation.
Tamper-evident audit trail
Every create, read, update, and delete action is recorded with user identity, timestamp, and reason for change — immutable and exportable for GMP inspection or regulatory review at any time.
Role-based access control
Granular permissions at programme, workstream, and document level — CROs and CDMOs see only what they need. Segregation of duties enforced by the platform, not by policy documents.
Single-tenant dedicated cloud
Your pharma data is never co-mingled with other companies or industries. A dedicated cloud instance — with dedicated storage, compute, and access controls — meeting GMP data security requirements.
Programme Milestone Dashboard
Live RAG-status view of all milestones across development, clinical, tech transfer, and capital project phases — with overdue actions highlighted and manufacturing readiness score.
ALCOA+ data integrity controls
All records are Attributable, Legible, Contemporaneous, Original, and Accurate — with the Additional principles of Complete, Consistent, Enduring, and Available — enforced by system architecture, not by user discipline.
Real-time visibility — from individual actions to executive programme overview
goPLIMS surfaces the right information for every stakeholder — from the scientist tracking a single tech transfer action to the programme director reviewing manufacturing readiness across all phases.
Programme Milestone Dashboard
Tech Transfer Status Report
Cross-Phase Action Register
Capital Project Punchlist & C&Q Report
Phase Readiness Score
Regulatory Submission Handover Pack
Compliance without the enterprise price tag
goPLIMS was designed from the ground up for regulated pharma — not adapted from a generic project management tool. Small and mid-size teams get the same cross-phase governance capability as enterprise systems, 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 every phase.
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 after the fact.
One integrated platform
The same platform that governs your audits, regulatory submissions, and knowledge management — sharing one audit trail, document store, and dedicated cloud across all programmes.
Live in days, not months
No lengthy implementation project. Configured to your programme structure and team and productive from day one — with onboarding support included across every phase.
Your questions answered.
es. goPLIMS governs product development, clinical trials, tech transfer, and capital project management on one integrated platform — sharing the same document store, action register, audit trail, and access controls. Each phase has its own programmes and workstreams, but all share the same governed foundation, enabling genuine cross-phase visibility for the first time.
goPLIMS manages tech transfer as a governed programme — with a structured action register for all transfer tasks, EDocM for controlled transfer of process documents and batch records, RFI-M for managing CDMO or site queries, and TrackR for real-time visibility of transfer progress against milestones. Every action and decision is traceable with a complete audit trail.
DecisionM captures every key decision — with rationale, alternatives considered, and outcome — so institutional knowledge is retained in the platform, not in people’s heads or email inboxes. When a team changes between development and clinical, or between clinical and tech transfer, the next team inherits a complete, searchable record of what was decided and why — not a blank slate.
Ready to govern every phase of your pharma audit programme?
See how goPLIMS replaces disconnected tools with one compliant, governed platform — purpose-built for pharma teams managing the path from molecule to manufacture.