SCIENOPS / DOCUMENTS, QUALITY & CMC
Scientific claims that stand up to source review.
Scientific claims that stand up to source review.
Connect important statements to the evidence, context and document versions reviewers need to assess them.
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DOCUMENT INTELLIGENCE
Recover the evidence behind the answer.
Recover the evidence behind the answer.
Find relevant passages, tables and analyses with their surrounding context. Preserve the qualifications, units, timing and limitations that determine what the source actually supports.
CONTROLLED REVIEW
Keep versions and review status explicit.
Keep versions and review status explicit.
Track the source version, evidence changes and open reviewer questions. Distinguish working interpretations from approved statements so that a later summary does not silently change their status.
REGULATORY & QUALITY
Prepare supporting material for rigorous review.
Prepare supporting material for rigorous review.
Organise sources, unresolved questions and claim support for submission preparation, quality reviews and inspection-related work. Required approvals and official records remain within the established process.
CMC & CHANGE CONTEXT
Assess what an evidence change affects.
Assess what an evidence change affects.
Review supporting material for comparability, specifications and process changes in chemistry, manufacturing and controls (CMC). Identify statements and documents that may need reassessment when the evidence changes.
AN EXAMPLE STARTING POINT
A claim-to-source review of a defined document set.
A claim-to-source review of a defined document set.
Select the claims and documents in scope. Evaluate retrieval, source support, context, version accuracy and the handling of missing or conflicting evidence, then document the issues that require resolution.
FIT WITH YOUR SYSTEMS
Fit the workflow to existing controls.
Fit the workflow to existing controls.
We agree connections, permissions, retention and approval responsibilities around your document, quality and regulatory systems. A successful demonstration does not establish regulatory compliance or submission readiness.
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