TMF Management

TMF Management

Our TMF Management Strategy is designed to analyze, prepare, implement, and audit your TMF to ensure you are ready for your organization’s next audit or agency inspection. Wherever you are in your process, our solution fits your needs.

Phase 1 Analysis and Preparation:

Documents the current state of your organization’s TMFs, the future desired state, and a roadmap of what it will take to achieve your goals.

Phase 2 Management Process Implementation

Implements activities defined in the roadmap to become inspection-ready.

Phase 3 TMF Finalization:

Conducts final risk-based correctness and completeness checks to ensure inspection readiness and provide final recommendations.

Phase 4 TMF Mock Audit :

Documents the current state of your organization’s TMFs, the future desired state, and a roadmap of what it will take to achieve your goals.

Phase 5 TMF Audit/ Inspection Support:

Assists our clients with on-demand, comprehensive inspection support in the event of agency inspections and partner audits.

Phase 1 Analysis and Preparation:

Documents the current state of your organization’s TMFs, the future desired state, and a roadmap of what it will take to achieve your goals.

Phase 2 Management Process Implementation

Implements activities defined in the roadmap to become inspection-ready.

Phase 3 TMF Finalization:

Conducts final risk-based correctness and completeness checks to ensure inspection readiness and provide final recommendations.

Phase 4 TMF Mock Audit :

Documents the current state of your organization’s TMFs, the future desired state, and a roadmap of what it will take to achieve your goals.

Phase 5 TMF Audit/ Inspection Support:

Assists our clients with on-demand, comprehensive inspection support in the event of agency inspections and partner audits.

pexels-anna-nekrashevich-6801872

Analysis & Preparation

Initial wellness check. initial TMF correctness review, OC TMF completeness
review (e.g., filed correctly, naming convention applied, request & reconcile
study trackers from COs, confirm translated docs and certificates, no duplications, etc.), recommended TMF plan.

TMF Management Process Implementation

TMF mapping, filing, scanning, QCing, create SOPs, add eTMF process in study
plans (monitoring plan, project management & communication plan, etc).

TMF Finalization

Final completeness and correctness review, finalize all documents and plans, provide final recommendations.

TMF Mock Audit

List of current process issues, list of gaps in documentation, list of any compliance concerns.

Analysis & Preparation

Initial wellness check. initial TMF correctness review, OC TMF completeness
review (e.g., filed correctly, naming convention applied, request & reconcile
study trackers from COs, confirm translated docs and certificates, no duplications, etc.), recommended TMF plan.

TMF Management Process Implementation

TMF mapping, filing, scanning, QCing, create SOPs, add eTMF process in study
plans (monitoring plan, project management & communication plan, etc).

TMF Finalization

Final completeness and correctness review, finalize all documents and plans, provide final recommendations.

TMF Mock Audit

List of current process issues, list of gaps in documentation, list of any compliance concerns.
pexels-anna-nekrashevich-6801872
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