, home
Customer access Request an enterprise demo
Request an enterprise demo Customer access

Pharmaceuticals & biotechnology / APPLICATION BLUEPRINT

AI Assisted Regulatory Drafting Evidence Provenance

Assists regulatory drafting using bounded, approved source material.

Start generatingExplore illustrative interface

11 workspace menus · 8 business workflows · 5 role profiles

Application blueprint only. This is a proposed design, not a deployed or production-tested system. Screens and sample figures are illustrative; workflows, business rules, approvals, permissions and integrations require confirmation before build.

Designed for programme coordinators and the responsible business owners

AI Assisted Regulatory Drafting Evidence Provenance workspace interface preview; illustrative records and figures.
AI Assisted Regulatory Drafting Evidence Provenance — operational workspaceIllustrative interface · Sample dataView full interface →

Explore an illustrative interface.

Illustrative workspace and record review. Select a concept screen to inspect it in full.

AI Assisted Regulatory Drafting Evidence Provenance workspace interface preview; illustrative records and figures.
AI Assisted Regulatory Drafting Evidence Provenance — operational workspaceIllustrative interface · Sample dataView full interface →
AI Assisted Regulatory Drafting Evidence Provenance record interface preview; illustrative records and figures.
AI Assisted Regulatory Drafting Evidence Provenance — record and workflow reviewIllustrative interface · Sample dataView full interface →

Operational dashboards and work queues.

Operational views

Review work, evidence, exceptions and authorised decisions within a defined operating scope.

Site / programmePeriodAssigned teamReview state

Dashboard measures

  • Active control records
    Count of all records in the selected workspace.
  • Review queue
    Records at the third stage of the business workflow.
  • Needs attention
    Records with an assigned review requirement.
  • Final-stage records
    Records in the fourth business workflow stage.

Business workflow and operating scope

Assists regulatory drafting using bounded, approved source material. Links proposed statements to evidence, routes drafts for specialist review and records accepted revisions, with version history and reviewer decisions preserved before content enters a submission workflow.

Operations

Operational overview

Review the work position and priority actions.

Proposed statements

Coordinate proposed statements with assigned responsibilities, linked records and review history.

Drafts

Coordinate drafts with assigned responsibilities, linked records and review history.

Accepted revisions

Coordinate accepted revisions with assigned responsibilities, linked records and review history.

Work register

Coordinate work register with assigned responsibilities, linked records and review history.

Supporting documents

Coordinate supporting documents with assigned responsibilities, linked records and review history.

Review workbench

Coordinate review workbench with assigned responsibilities, linked records and review history.

Insights

Reports and saved views

Review the reporting scope and export agreed operational views.

Governance

Approvals and exceptions

Review delegated decisions, exceptions and recorded conditions.

Audit history

Trace accepted changes, decisions and accountable actions.

Access and configuration

Manage the agreed role permissions and configurable operating rules.

The end-to-end business journey.

From intake to authorised completion, with evidence at each decision.

01

Define the control scope

Establish the scope of proposed statements, capture the required records and assign the accountable team.

02

Collect evidence and exceptions

Coordinate drafts, accepted revisions, with linked evidence and visible outstanding actions.

03

Record the review decision

Review the relevant conditions and exceptions. Record the authorised outcome and its supporting evidence.

04

Track corrective actions

Confirm the resulting records and handovers. Track remaining obligations, later changes and follow-up actions.

Business workflows

Select a workflow to review the steps, responsibilities, approval and exception handling.

01 · Link proposed statements

Coordinate proposed statements within AI Assisted Regulatory Drafting Evidence Provenance.

Trigger
Proposed statements requires a new record, an agreed review or a controlled change.

Responsible role
Programme coordinator

  • Register proposed statements and its operating scope
  • Coordinate the required specialist and business review
  • Accept the release version and permitted recipients
  • Record distribution, acknowledgement and later revisions

Approval
Authorised release reviewer records the decision when the action changes an accepted commitment or requires delegated authority.

Exception handling
Content conflicts, missing review or a changed recipient permission prevents release.

Outcome
An accepted content version with distribution and revision history.

02 · Route drafts

Coordinate drafts within AI Assisted Regulatory Drafting Evidence Provenance.

Trigger
Drafts requires a new record, an agreed review or a controlled change.

Responsible role
Programme coordinator

  • Register drafts and its operating scope
  • Assign the accountable owner and required actions
  • Review the relevant evidence and unresolved conditions
  • Confirm the accepted outcome and retain its history

Approval
Authorised release reviewer records the decision when the action changes an accepted commitment or requires delegated authority.

Exception handling
Required information or responsibility is missing, or an operating condition changes.

Outcome
A completed operating record with its linked evidence and remaining obligations.

03 · Record accepted revisions

Coordinate accepted revisions within AI Assisted Regulatory Drafting Evidence Provenance.

Trigger
Accepted revisions requires a new record, an agreed review or a controlled change.

Responsible role
Programme coordinator

  • Register accepted revisions and its operating scope
  • Assign the accountable owner and required actions
  • Review the relevant evidence and unresolved conditions
  • Confirm the accepted outcome and retain its history

Approval
Authorised release reviewer records the decision when the action changes an accepted commitment or requires delegated authority.

Exception handling
Required information or responsibility is missing, or an operating condition changes.

Outcome
A completed operating record with its linked evidence and remaining obligations.

04 · Register the operating requirement

Coordinate operating requirement within AI Assisted Regulatory Drafting Evidence Provenance.

Trigger
Operating requirement requires a new record, an agreed review or a controlled change.

Responsible role
Programme coordinator

  • Register operating requirement and its operating scope
  • Compare options, dependencies and operating constraints
  • Review the selected option with its accountable owners
  • Accept the plan and track its delivery conditions

Approval
Authorised release reviewer records the decision when the action changes an accepted commitment or requires delegated authority.

Exception handling
An assumption changes, prerequisites are missing or stakeholders cannot accept the proposed commitment.

Outcome
An approved operating plan and owned actions for its accepted conditions.

05 · Resolve operating exceptions

Coordinate operating exceptions within AI Assisted Regulatory Drafting Evidence Provenance.

Trigger
Operating exceptions requires a new record, an agreed review or a controlled change.

Responsible role
Programme coordinator

  • Register operating exceptions and its operating scope
  • Gather the relevant evidence and review options
  • Route the case to the delegated decision owner
  • Record the outcome, conditions and follow-up obligations

Approval
Authorised release reviewer records the decision when the action changes an accepted commitment or requires delegated authority.

Exception handling
The case exceeds delegation, contains a conflict or has disputed evidence.

Outcome
An authorised decision or escalation with accountable resolution actions.

06 · Verify completion and follow-up

Coordinate completion and follow-up within AI Assisted Regulatory Drafting Evidence Provenance.

Trigger
Completion and follow-up requires a new record, an agreed review or a controlled change.

Responsible role
Evidence reviewer

  • Register completion and follow-up and its operating scope
  • Collect the linked records and qualified evidence
  • Assign the responsible reviewer and record findings
  • Accept the outcome or assign corrective follow-up

Approval
Authorised release reviewer records the decision when the action changes an accepted commitment or requires delegated authority.

Exception handling
Evidence is incomplete, disputed, expired or outside the reviewer’s authority.

Outcome
A review finding, its accepted evidence and any accountable corrective actions.

07 · Review controlled operating changes

Coordinate controlled operating changes within AI Assisted Regulatory Drafting Evidence Provenance.

Trigger
Controlled operating changes requires a new record, an agreed review or a controlled change.

Responsible role
Evidence reviewer

  • Register controlled operating changes and its operating scope
  • Collect the linked records and qualified evidence
  • Assign the responsible reviewer and record findings
  • Accept the outcome or assign corrective follow-up

Approval
Authorised release reviewer records the decision when the action changes an accepted commitment or requires delegated authority.

Exception handling
Evidence is incomplete, disputed, expired or outside the reviewer’s authority.

Outcome
A review finding, its accepted evidence and any accountable corrective actions.

08 · Prepare scoped operational reports

Coordinate scoped operational reports within AI Assisted Regulatory Drafting Evidence Provenance.

Trigger
Scoped operational reports requires a new record, an agreed review or a controlled change.

Responsible role
Programme coordinator

  • Register scoped operational reports and its operating scope
  • Assign the accountable owner and required actions
  • Review the relevant evidence and unresolved conditions
  • Confirm the accepted outcome and retain its history

Approval
Authorised release reviewer records the decision when the action changes an accepted commitment or requires delegated authority.

Exception handling
Required information or responsibility is missing, or an operating condition changes.

Outcome
A completed operating record with its linked evidence and remaining obligations.

Governance and control

  • Role permissions reflect the agreed responsibilities and restricted record access.
  • Required information and evidence are checked before the relevant decision or handover.
  • Exceptions have a named owner, recorded reason and an authorised resolution.
  • Approved changes retain their previous values, accountable decisions and linked evidence.
  • Integration mappings, business rules and acceptance criteria are reviewed with the customer.
Operating rules by business workflow
  • For proposed statements, the released version and authorised audience remain traceable to the accepted review.
  • For drafts, the record retains an accountable owner, its supporting evidence and accepted outcome.
  • For accepted revisions, the record retains an accountable owner, its supporting evidence and accepted outcome.
  • For operating requirement, the accepted plan records assumptions, rejected alternatives, dependencies and conditions.
  • For operating exceptions, a decision retains its authority, reason, supporting evidence and resulting obligations.
  • For completion and follow-up, evidence, reviewer authority and acceptance conditions are visible before a reviewed outcome is accepted.
  • For controlled operating changes, evidence, reviewer authority and acceptance conditions are visible before a reviewed outcome is accepted.
  • For scoped operational reports, the record retains an accountable owner, its supporting evidence and accepted outcome.

Data, interfaces and operating requirements.

Core records

Control recordProposed statementsDraftsAccepted revisionsDecisionSupporting evidenceActivity history
Record fields and linked information
  • Record identifier — Stable reference for the operating transaction.
  • Site / programme — Business scope used for responsibility and reporting.
  • Operating subject — The request, commitment or work item being handled.
  • Accountable owner — Named responsibility for the next action.
  • Workflow stage — Current position in the agreed business journey.
  • Review requirement — Required review and outstanding decision.
  • Due or review date — Agreed action window or review trigger.
  • Linked evidence — Source records supporting the operating decision.
  • Decision authority — The delegated authority relevant to the accepted outcome.
  • Accepted outcome — Recorded decision and its business consequences.
  • Follow-up obligation — Remaining responsibilities after an accepted action.
  • Revision history — Trace of accepted changes and their evidence.
  • Proposed statements reference — Link the relevant proposed statements to the operating transaction and its decision evidence.
  • Drafts reference — Link the relevant drafts to the operating transaction and its decision evidence.
  • Accepted revisions reference — Link the relevant accepted revisions to the operating transaction and its decision evidence.
  • Work register reference — Link the relevant work register to the operating transaction and its decision evidence.
  • Supporting documents reference — Link the relevant supporting documents to the operating transaction and its decision evidence.

Systems and interfaces

  • Quality and controlled document records
  • Laboratory, trial or product information interfaces
  • Identity and role-based access services
  • Approved document and communication services

Interface scope, data mapping and testing are agreed for each engagement.

Implementation requirements
Confirm the operating boundaries, proposed statements, responsible roles, review authority, record retention, interface mappings and acceptance scenarios.

Mobile and tablet access

Authorised users can review proposed statements, supporting records and assigned actions through mobile and tablet access. The relevant tasks and permissions are agreed for the deployment.

Access approved workflows through the Dalfin mobile app. Device tasks and permissions are confirmed for the deployment.

Apple App Store ↗Google Play ↗

AI extensions

AI-assisted summarisation, evidence retrieval or scenario comparison can be scoped around aI Assisted Regulatory Drafting Evidence Provenance. Outputs remain reviewable, with authorised people responsible for consequential decisions.

AI extensions are scoped around the required data, business outcome and review controls.

Engineered with Genesis.

Structured application engineering

Connect requirements, roles, records, workflows and interfaces through the agreed Genesis engineering process.

Controlled changes

Review dependency impact and validation requirements. Context Memory supports governed changes and accepted application revisions.

Deployment and support

Agree customer cloud or on-premises requirements, device access, implementation acceptance and ongoing engineering support.

AN EXAMPLE OPERATING SCENARIO

What to validate in a scoped demonstration.

Start with proposed statements and follow the record through collect evidence and exceptions. Introduce a missing item or operating exception, record the authorised resolution and inspect the final handover, evidence and history.

What to review

  • A saved end-to-end transaction
  • An exception and its authorised resolution
  • Different operator, approver and reviewer permissions
  • Final records, history and the relevant report
Discuss this solution

Questions before implementation.

What can we review in a tailored demonstration?

Review a representative control record, its workflow stages, accountable roles, an exception and the resulting operational report. Bring the business process and existing system requirements that matter to your organisation.

How is the solution adapted to our organisation?

The operating scope covers your records, role permissions, review authority, business rules and integration boundaries. These requirements are agreed with the responsible business owners.

How does the solution connect with existing systems?

Connection design defines interfaces, data ownership, mapping, authentication and exception handling. The agreed implementation includes validation against the selected systems and workflows.

How are subsequent changes controlled?

The agreed engineering approach covers review of change impact, bounded implementation, validation and accepted revisions. Discuss the relevant Genesis Context Memory and support requirements during solution scoping.