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These playbooks show how to combine Sofie surfaces for common life sciences work. Start with the source material, use chat for reasoning, then move the result into the right artifact.
Review all outputs before using them in regulated, quality, clinical, or controlled processes. Sofie helps prepare work for human review.

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How to use these playbooks

Most workflows follow the same pattern:
1

Create a Workspace

Put the project files, data, meetings, and artifacts in one place.
2

Ask Sofie for a source-backed first pass

Use Workspace search, attachments, or specific artifact context.
3

Separate facts from assumptions

Ask Sofie to identify source-backed findings, gaps, assumptions, and questions.
4

Move into an artifact

Use CoDraft for documents, CoSheet for structured data, CoMeeting for discussion capture, or Orchestrate for repeatable steps.
5

Review with humans

Confirm the output with SMEs, QA, regulatory, manufacturing, or other responsible reviewers.

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Tech transfer

Use Sofie to organize transfer sources, identify gaps, capture SME knowledge, and draft transfer artifacts. Best source set:
  • Process descriptions.
  • Analytical methods.
  • Facility and equipment constraints.
  • Prior development reports.
  • Critical process parameter and critical quality attribute summaries.
  • CDMO or receiving site questions.
  • SME meeting transcripts.
Recommended Sofie flow:
  1. Create a Workspace for the transfer.
  2. Add source documents and meeting captures.
  3. Use Workspace search for gap analysis.
  4. Use CoMeeting for SME interviews.
  5. Use CoDraft for a charter, handoff brief, or gap report.
  6. Use Orchestrate when you repeat the transfer assessment pattern.
Prompt: 
Use this Workspace to create a tech transfer gap analysis. Group gaps by process, analytical, quality, facility, supply chain, and regulatory. For each gap, include source support, assumption, follow-up question, and suggested owner.
Useful Orchestrations to look for:
  • Tech Transfer Charter Generator
  • CMC Development & Tech Transfer Workflow
  • Tech Transfer Launch Optimizer-1

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Deviation investigation

Use Sofie to structure facts, source gaps, interview questions, and draft investigation text. Best source set:
  • Event summary.
  • Batch record excerpts.
  • Equipment or process data.
  • Relevant SOPs.
  • Test results.
  • Prior similar deviations.
  • SME interview CoMeetings.
Recommended Sofie flow:
  1. Add materials to a Workspace.
  2. Ask Sofie to separate known facts, assumptions, missing evidence, and investigation paths.
  3. Capture interviews with CoMeeting.
  4. Use CoSheet for issue tracking or evidence logs.
  5. Use CoDraft for investigation narrative.
  6. Use Orchestrate for recurring deviation report workflows.
Prompt: 
Review these deviation materials. Create a table with known facts, unsupported assumptions, missing evidence, possible impact, next source to check, and follow-up questions. Do not infer root cause without source support.
Useful Orchestrations to look for:
  • Deviation Investigation Report Author
  • Deviation Investigation Review & Verification
  • Root Cause Analysis (RCA) - Deviation Investigation
  • OOS/OOT Investigation

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CAPA development

Use Sofie to connect root cause, action plan, evidence, owner, due date, and effectiveness criteria. Recommended Sofie flow:
  1. Start from the final or draft investigation summary.
  2. Ask Sofie to map each proposed action to a cause or contributing factor.
  3. Use CoDraft for the CAPA plan narrative.
  4. Use CoSheet for action tracking and evidence status.
  5. Use Orchestrate for repeatable CAPA development.
Prompt: 
Evaluate this CAPA plan for traceability. For each action, list the linked cause, evidence needed, owner, due date, effectiveness measure, risk if incomplete, and open question for review.
Useful Orchestrations to look for:
  • CAPA Development
  • CAPA Recommendations

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CAPA effectiveness checks

Use Sofie to evaluate whether actions have evidence that supports effectiveness. Best source set:
  • Original CAPA record.
  • Implementation evidence.
  • Training or procedure change records.
  • Pre- and post-implementation metrics.
  • Deviation, complaint, or quality metric trends.
  • Effectiveness check SOP or criteria.
Recommended Sofie flow:
  1. Put CAPA record and evidence in a Workspace.
  2. Use CoSheet for metrics and trend tables.
  3. Ask Sofie to compare expected outcome to observed evidence.
  4. Use CoDraft for an effectiveness check summary.
  5. Use Orchestrate for recurring effectiveness check structure.
Prompt: 
Assess this CAPA effectiveness package. Separate implemented actions, objective evidence, pre/post metrics, remaining recurrence signals, unsupported conclusions, and questions for the CAPA owner.
Useful Orchestration to look for:
  • CAPA Effectiveness Check

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URS and equipment qualification

Use Sofie to turn needs, constraints, and process requirements into clearer requirements and qualification drafts. Best source set:
  • Process needs.
  • User requirements.
  • Vendor materials.
  • Existing URS examples.
  • Risk assessment.
  • Qualification templates.
  • Applicable internal standards.
Recommended Sofie flow:
  1. Create a Workspace for equipment or system qualification.
  2. Ask Sofie to draft testable URS statements.
  3. Use CoDraft for URS, DQ, IQ, OQ, PQ, or qualification report drafts.
  4. Use CoSheet for requirement traceability.
  5. Use Orchestrate for recurring URS or protocol generation.
Prompt: 
Draft testable URS requirements from these notes. Use requirement IDs, user need, requirement statement, acceptance criteria, rationale, verification method, and SME confirmation needed.
Useful Orchestrations to look for:
  • User Requirements Specification Builder
  • URS Generation
  • Equipment URS Generator
  • Equipment Qualification Protocol Generator
  • Equipment Qualification Report Generator

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Validation protocol generation

Use Sofie to assemble protocol structure, source assumptions, sampling plans, acceptance criteria, and open questions. Recommended Sofie flow:
  1. Place validation plan inputs in a Workspace.
  2. Use CoMeeting to capture planning discussions.
  3. Use CoSheet for sampling plans or data tables.
  4. Use CoDraft for the protocol.
  5. Use Orchestrate for recurring protocol generation patterns.
Prompt: 
Use this Workspace to outline a process validation protocol. Include objective, scope, responsibilities, sampling plan, acceptance criteria, deviations handling, data analysis, source gaps, and unresolved SME questions.
Useful Orchestrations to look for:
  • Process Validation Protocol Generator
  • Validation Protocol Generation Orchestration
  • Validation Master Plan Generator

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Batch record review

Use Sofie to summarize batch record issues, extract follow-up questions, and organize review notes. Recommended Sofie flow:
  1. Upload batch record excerpts and supporting documents.
  2. Ask Sofie to identify documentation gaps, ambiguous entries, missing signatures, unclear dates, and data that needs review.
  3. Use CoSheet for a structured issue log.
  4. Use CoDraft for the review summary.
  5. Use Orchestrate for recurring review structure.
Prompt: 
Review these batch record excerpts. List documentation gaps, ambiguous entries, potential impact, source location, and questions for manufacturing. Do not infer root cause without source support.
Useful Orchestration to look for:
  • GMP Batch Record Review Orchestration

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Regulatory and pharmacopoeia research

Use Sofie to collect public context and turn it into a source-backed brief. Recommended Sofie flow:
  1. Use Web search or Deep research when the question depends on public sources.
  2. Ask for citations.
  3. Save the brief as a CoDraft.
  4. Keep internal project files in a Workspace so Sofie can compare public context with internal context.
Prompt: 
Research public regulatory and pharmacopoeia context for this topic. Summarize key points, cite sources, separate public-source findings from internal assumptions, and list questions that need regulatory review.
Useful Orchestrations to look for:
  • Regulatory Compliance Explorer
  • Pharmacopoeia Monograph Comparative Analyzer
  • Cell & Gene Therapy Regulatory Research

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Quality risk assessment

Use Sofie to structure hazards, causes, controls, detectability, severity, occurrence, and recommended actions. Recommended Sofie flow:
  1. Add source documents, process maps, prior risk assessments, and meeting notes to a Workspace.
  2. Ask Sofie to draft a risk table.
  3. Use CoSheet for scoring and sorting.
  4. Use CoMeeting for cross-functional review.
  5. Use CoDraft for the final narrative.
  6. Use Orchestrate for repeatable risk assessment structure.
Prompt: 
Create a quality risk assessment table from these sources. Include hazard, cause, effect, existing controls, severity, occurrence, detectability, rationale, recommended action, owner, and open questions.
Useful Orchestrations to look for:
  • Quality Risk Assessment
  • Master Risk Assessment
  • Development to Manufacturing Scale-Up Risk Assessment

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Annual product review

Use Sofie to compile, summarize, and question annual product quality data. Recommended Sofie flow:
  1. Create a Workspace for APR or PQR source files.
  2. Add batch summaries, QC results, stability data, deviations, CAPA summaries, complaints, changes, and prior review material.
  3. Use CoSheet for trend tables and charts.
  4. Use CoDraft for the review narrative.
  5. Use Orchestrate for repeatable review structure.
Prompt: 
Use this Workspace to prepare an APR source summary. Group findings by manufacturing, QC, stability, deviations, CAPA, complaints, and changes. Identify trends, missing data, assumptions, and follow-up questions.
Useful Orchestration to look for:
  • Annual Product Review (APR/PQR)

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Connect the surfaces