Objective
Phase 0 answers three questions before a single line of code is written: What is the current content process? Where does it break? What would "done" look like?
The single most common failure pattern in content operations platform projects: teams procure Microsoft Fabric and Azure AI licenses, build integrations, and then discover the underlying review and approval process was never agreed between Medical, Legal, and Brand. Result: a sophisticated system for automating disagreements.
Produce a signed-off, swimlane-level description of the content lifecycle that all stakeholders (Medical Affairs, Legal, Brand, Content Ops, Regulatory, IT) agree reflects how work should flow — not how it currently muddles through. This document becomes the specification for every Phase 1+ build decision.
Week-by-Week Plan
Six weeks split into three two-week sprints: Discovery, Validation, Baseline.
1 – 2
- Schedule and run 8 stakeholder interviews (45 min each) — see Departments section for who
- Shadow one live content item from brief submission to MLR approval — observe real handoffs
- Map as-is process in Miro: every step, every decision, every role, every tool currently used
- Identify all points where content waits without anyone actively working on it (latency hotspots)
- Document all current tools: what's used, by whom, whether it's official or shadow IT
- Collect sample content items from the last 12 months: measure actual cycle times
3 – 4
- Present as-is swimlane in validation workshop with all stakeholders — get explicit sign-off or corrections
- Propose to-be 8-state lifecycle schema — walk through each state and resolve disagreements
- Audit the existing claims register: completeness, currency, ownership, format
- Identify all approved modular content blocks (boilerplate, ISI, disclaimer text) that can seed the OneLake library
- Map data privacy requirements: which content types contain personal data? Which markets require GDPR scope?
- Confirm Veeva PromoMats contract scope: which MLR workflow states does current license cover?
5 – 6
- Pull cycle time data for last 20 content items: days per state, number of revision cycles, final word count
- Calculate current baselines: avg cycle time, avg MLR revision cycles, content reuse rate (estimated)
- Run one content item manually through the agreed to-be 8-state process — no tools, just forms and email
- Document every friction point and decision gap encountered during manual pilot
- Draft Phase 0 Final Report with gap analysis and Phase 1 go/no-go recommendation
- Present report to sponsor. Get sign-off before any Azure procurement begins.
Departments & Roles
Phase 0 is a cross-functional discovery exercise. Every department listed below must have at least one representative in the validation workshop. Missing a department means encoding their process incorrectly.
Interview focus: What makes a submission ready for medical review? What are the most common rejection reasons? How are parallel tracks (Medical / Legal / Regulatory) currently coordinated? Who has final authority when Medical and Regulatory disagree?
Interview focus: What is the claims register status today — who owns it? What are the most frequently flagged claim types? Which markets require different legal disclaimers? E-signature requirements and 21 CFR Part 11 scope.
Interview focus: Where are brand guidelines stored today? How are briefs currently submitted — email, form, or ad-hoc? What is the most painful handoff point between Brand and Content? What constitutes a "brief" vs a "request"?
Interview focus: How do writers currently receive briefs? What tools are used for drafting — Word, Google Docs, SharePoint? Where do documents live during review? How is versioning managed? What percentage of content is truly net-new vs derivative?
Interview focus: Which markets require regulatory pre-approval of content? What is the current localisation review process? How are country-specific regulatory addenda managed? GxP audit trail requirements — what must be logged and retained?
Interview focus: Current Microsoft 365 licensing tier (E3 vs E5). Existing Azure subscription scope. Data residency requirements (EU, US, etc.). Identity provider (Entra ID configuration). Existing Veeva contract and API access scope. Any active API rate limits or security restrictions.
Interview focus: How many markets will be in scope for Phase 1? What languages? How is localisation currently handled — in-house or agency? What is the current turnaround for a translated piece? Who approves localised content — local Medical Affairs or HQ?
Engagement focus: Confirm success criteria and target metrics for Phase 1. Approve Phase 0 Final Report. Unblock cross-departmental conflicts identified in the swimlane (e.g. who owns the claims register?). Confirm budget envelope for Phases 1–3.
Tools Used in Phase 0
Phase 0 deliberately uses no custom infrastructure. All tools should already be available in the organisation or have free tiers. Zero Azure spend until Phase 0 sign-off.
Azure AI Foundry, Microsoft Fabric, Copilot Studio, and Azure OpenAI are not provisioned in Phase 0. Any stakeholder who asks to "start building" during discovery should be redirected: undefined process → automated undefined process. The only exception is if IT needs to set up an Azure subscription or M365 tenant to be ready for Phase 1 — that setup can run in parallel but should not inform Phase 0 decisions.
Deliverables
Miro board exported as PDF and PNG. Shows every current step, role, tool, and handoff point. Annotated with measured cycle times per stage from the last 20 content items. Signed off by all department representatives.
Agreed definition of each of the 8 lifecycle states: entry criteria, exit criteria, role responsible, expected SLA, decision rules. Exported as a SharePoint document. This becomes the canonical reference for all Phase 1+ development. Version 1.0 locked after stakeholder sign-off workshop.
Excel workbook listing every claim currently in use across all markets. Columns: claim text, indication, approved date, expiry date, supporting reference document, market scope, owner, status (current / expired / missing reference). Gap analysis: % of claims with complete metadata. Minimum threshold for Claims Validation Service activation: 90% completeness.
Measured from actual content items in the last 12 months: average end-to-end cycle time (brief to live), average MLR revision cycles per item, estimated content reuse rate, average localisation turnaround, number of content items per month by type. These numbers are the "before" benchmark for all Phase 1–3 improvements.
List of all existing approved content blocks that can be seeded into the OneLake modular content library in Phase 1: ISI text, standard disclaimers, approved product descriptions, fair balance statements. Each block tagged with: indication, market scope, expiry date, MLR approval reference.
Executive summary (5 slides) for project sponsor. Covers: findings from discovery, agreed to-be process, claims register gap, baseline metrics, risks identified, Phase 1 scope recommendation and estimated cost range. Must receive explicit written sign-off from sponsor before any Phase 1 procurement begins.
Exit Criteria — Gate to Phase 1
All six criteria must be met before Phase 1 begins. No partial exceptions — a missing criterion means Phase 0 extends, not Phase 1 starts early.
All 8 lifecycle states agreed and documented. Signed by Medical Affairs, Legal, Brand, Content Ops, and Regulatory Affairs leads.
At least 90% of active claims have complete metadata (reference, expiry, market scope, owner). Owner assigned to maintain the register in Phase 1+.
Cycle time, revision count, and reuse rate baseline measured from minimum 20 real content items. Numbers agreed and accepted by sponsor.
At least one content item has been walked through the to-be 8-state process manually. Friction points documented and addressed in spec.
M365 licensing tier confirmed. Azure subscription exists or creation approved. Data residency requirements documented. Entra ID admin contact identified.
Project sponsor has approved the Phase 1 budget envelope (see Phase 1 for cost estimates). Procurement lead identified for Microsoft Fabric capacity order.