CMC & Manufacturing
Tech Transfer Management
Govern your technology transfer from sending site to manufacturing readiness
From process characterisation documentation through CDMO onboarding, analytical method transfer, and commercial manufacturing readiness — one governed, 21 CFR Part 11 compliant platform replacing email chains with CDMOs and shared process document drives.
Dedicated pharma cloud | Sending site & CDMO on one platform | Purpose-built for pharma CMC
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Technology transfer runs on email chains with CDMOs and shared drives of process documents — no governed handoff, no traceable queries
Technology transfer is one of the highest-risk phases in the pharmaceutical development journey. A single missing process parameter, an unresolved CDMO query, or a process document version confusion can delay commercial manufacturing by months — and create the CMC compliance gaps that inspectors find during PAI.
Most teams manage tech transfer through email threads with the CDMO, Excel trackers of process document delivery, and shared drives with no version control. There is no governed record of what was transferred, when, by whom, and whether the CDMO confirmed receipt and understanding.
- Email chains with CDMOs for process document delivery and queries
- Shared drives with no version control or CDMO receipt confirmation
- Excel trackers manually updated to monitor transfer progress
- Separate tools for process docs, queries, and analytical transfer
- Transfer knowledge lost when process development scientists move on
A governed tech transfer platform where process documents, CDMO queries, analytical transfer protocols, and manufacturing readiness milestones are all managed in one compliant, traceable system — with the sending site and receiving CDMO working in the same governed environment.
End-to-end governance from transfer planning through manufacturing readiness
goPLIMS governs every phase of the technology transfer programme — from transfer planning and process document delivery through CDMO query management, analytical method transfer, and formal manufacturing readiness sign-off.
Real tech transfer scenarios governed by goPLIMS
From biologic drug substance to OSD commercial scale — goPLIMS governs the process and knowledge transfer complexity that determines whether your first commercial batch succeeds.
Biologics · DS
Biologic drug substance tech transfer from EU originator site to US CDMO
A Phase III biologics programme transfers cell culture, purification, and formulation processes from an EU research site to a US commercial CDMO. goPLIMS governs the complete transfer — process descriptions, batch records, and analytical methods delivered through EDocM with e-signed receipt, CDMO technical queries managed as formal RFIs, and a live TrackR dashboard showing section-by-section transfer completion against the PPQ timeline.
Small molecule · API
API process transfer from internal development site to commercial CMO for NDA filing
A specialty pharma company transfers its synthetic API process from an internal development facility to a commercial CMO ahead of NDA filing. goPLIMS governs the process package delivery — master batch record, process descriptions, in-process controls, and specification documents — with the CMO raising technical questions via RFI-M and process development scientists at the originating site responding within agreed timelines, all with a complete audit trail for the regulatory dossier.
OSD · DP
Oral solid dosage drug product transfer — formulation to fill-finish CDMO
A generic pharma team transfers an OSD drug product formulation to a CDMO fill-finish operation. goPLIMS governs the analytical method transfer across four HPLC and dissolution methods — transfer protocols reviewed, transfer studies executed with results recorded, transfer reports approved in EDocM with ESignM, and the complete analytical transfer package available for the ANDA submission without any additional document collection.
Knowledge transfer
Capturing process development knowledge when the scientist who developed the process retires
A 25-year process development chemist with unique knowledge of a complex synthetic process is retiring before commercial tech transfer is complete. goPLIMS captures the process rationale, critical parameter decisions, and troubleshooting knowledge in DecisionM during structured knowledge transfer sessions — ensuring the CDMO team inherits not just the master batch record, but the understanding of why every step was designed the way it was.
The goPLIMS modules powering tech transfer management
Six purpose-built modules working together on one dedicated, 21 CFR Part 11 compliant cloud — connecting sending site, CDMO, and regulatory submission team on one platform throughout the technology transfer programme.
ActionR
Action Management
All transfer programme actions — document delivery milestones, study execution tasks, CDMO responsibilities, analytical transfer steps — tracked with owner and deadline across both sending and receiving organisations on one governed register.
EDocM
Electronic Document Management
A governed repository for all transfer documents — master batch records, process descriptions, SOPs, specifications, and analytical methods — version-controlled, with e-signed delivery confirmation from the CDMO and linked to the regulatory submission package.
RFI-M
RFI Management
Every CDMO technical query managed as a formal RFI — received, assigned to the appropriate process development expert, answered with supporting documentation, reviewed, and issued with a complete audit trail. The CDMO query register that inspectors will review during PAI.
DecisionM
Decision Management
Capture every process transfer decision — scale-up parameter adjustments, critical process parameter ranges, troubleshooting resolutions — so the CDMO inherits not just the process documentation, but the process understanding essential for successful commercialisation.
TrackR
Central Online Tracker
A live transfer progress dashboard — process section delivery status, CDMO query resolution rate, analytical transfer completion, and manufacturing readiness score — updated automatically as actions and documents progress through the programme.
FormM
Form Management
Govern analytical method transfer protocols as structured electronic forms — version-controlled, with execution data entry, results review, and a 21 CFR Part 11 compliant e-signed approval on every method transfer report.
Tech transfer records that satisfy GMP inspection requirements at PAI
Every process document, CDMO query, and analytical transfer report in goPLIMS is governed by data integrity controls that meet the standards FDA and EMA apply during pre-approval inspections of the commercial manufacturing site.
E-signed process document delivery
Every process document delivered to the CDMO is version-controlled in EDocM and acknowledged with a 21 CFR Part 11 compliant e-signature — creating a timestamped, tamper-evident record of exactly what was transferred, when, and in which version.
Traceable CDMO query audit trail
Every CDMO technical query — from submission through internal review, response, and CDMO acceptance — is captured in an immutable audit trail. When an inspector asks how a critical parameter discrepancy was resolved, the complete exchange is in the platform.
Controlled CDMO access
The CDMO sees only the documents and actions assigned to their transfer workstream — no exposure to other programmes, partner CDMOs, or confidential process information outside their specific scope of transfer.
Single-tenant dedicated pharma cloud
Your process documents, formulation data, and CDMO correspondence are never co-mingled with other pharmaceutical companies. A dedicated cloud instance protecting your CMC intellectual property throughout the technology transfer programme.
Long-term record retention and encryption
All tech transfer records retained for the GMP-required period — encrypted at rest and in transit, with automated backup and point-in-time recovery ensuring the complete transfer record is always available for post-approval inspection or lifecycle management submissions.
PAI-ready transfer package
The complete tech transfer record — process documents, CDMO query history, analytical transfer reports, and manufacturing readiness sign-off — is exportable as a structured, e-signed package for the regulatory submission CMC section and PAI inspection.
Real-time visibility from document delivery to manufacturing readiness
goPLIMS gives tech transfer managers, CMC leads, and programme directors the visibility they need — and generates the inspection-ready transfer record that regulators expect at PAI — automatically, as the programme runs.
Tech Transfer Progress Dashboard
Process Document Delivery Status
CDMO Query Register
Analytical Transfer Completion Report
Manufacturing Readiness Score
Knowledge Transfer Archive
Purpose-built for pharma tech transfer — not generic file sharing
Shared drives and email are not technology transfer platforms. goPLIMS was designed specifically for the governance requirements of pharmaceutical process transfer — GMP data integrity, CDMO oversight, and regulatory submission readiness built in from day one.
Single dedicated cloud
Your process documents and formulation IP are never shared with other companies. A dedicated deployment protecting your CMC intellectual property throughout the technology transfer programme.
21 CFR Part 11 by design
Every process document delivery, CDMO query response, and analytical transfer report is governed by 21 CFR Part 11 compliant records and e-signatures — producing the PAI-ready transfer record automatically.
Connected to regulatory submission
Process documents approved in goPLIMS during tech transfer feed directly into the CMC section of the regulatory submission on the same platform — no file migration needed when the PPQ programme concludes.
Live in days, not months
Configured to your transfer programme — your process sections, your CDMO, your analytical method list — and productive from day one. The CDMO is onboarded with controlled access and the transfer programme begins immediately.
Your questions answered.
goPLIMS manages the transfer as a governed programme — all process documents and batch records transferred through EDocM with version control and e-signed delivery confirmation, all handoff actions tracked in ActionR with owner and deadline, CDMO questions managed as RFIs, and transfer progress tracked in real time via TrackR. The sending site and receiving site both work in the same platform, with role-based access controlling what each party can see and do.
Yes. CDMOs and CMOs access goPLIMS with controlled, role-based permissions specific to the transfer programme — they can receive and acknowledge process documents in EDocM, submit queries as RFIs in RFI-M, and update their assigned action items in ActionR. All CDMO activity is logged with a complete audit trail, and the CDMO has no visibility of other programmes or confidential data outside their own transfer workstream.
Every CDMO technical query is managed as a formal RFI in RFI-M — received, assigned to the appropriate process development or CMC owner at the sending site, answered with any supporting documents attached, reviewed, and issued with a response deadline and audit trail. The CDMO query register provides real-time visibility of all open, responded, and closed queries — and the query history is retained permanently as part of the tech transfer record.
The tech transfer programme in goPLIMS runs on the same platform as the regulatory submission readiness workstream. Process documents transferred and approved in EDocM during tech transfer feed directly into the CMC section of the regulatory submission — the same governed document store, the same audit trail. There is no need to assemble a separate regulatory package from tech transfer files after the programme concludes.
Ready to govern your tech transfer from sending site to manufacturing readiness?
See how goPLIMS connects your sending site and CDMO on one governed platform — replacing email and shared drives with a compliant, inspection-ready tech transfer record.