Project Context
You are the program manager for MedAxis, a healthcare SaaS company that provides an eClinical platform used by pharma sponsors to run Phase II/III clinical trials. MedAxis processes data from ~1,200 trial sites globally, ingesting ~8–10 million patient form submissions per month (ePRO, lab integrations, adverse event reports). A top-5 pharma customer, Orion Therapeutics, is expanding usage from 6 to 18 concurrent trials, and has made it a contractual requirement that MedAxis demonstrate strong data integrity controls aligned to ALCOA+ (Attributable, Legible, Contemporaneous, Original, Accurate + Complete, Consistent, Enduring, Available).
In 10 weeks, Orion will undergo an FDA inspection for one of the trials running on MedAxis. While MedAxis is not the regulated entity, Orion will present MedAxis as a critical vendor; any findings tied to MedAxis could lead to a 483 observation, delays in submission, and reputational damage. Internally, the CEO has committed to Orion that MedAxis will provide an “audit-ready package” and implement high-priority remediation before the inspection.
Your cross-functional team is distributed and partially shared:
| Function | Headcount Available | Notes |
|---|
| Backend Engineering | 5 | 2 are shared with a revenue-critical billing rewrite (50% capacity) |
| Data Platform | 3 | Owns event pipeline + warehouse; on-call load is high |
| Frontend Engineering | 2 | Owns investigator UI and e-signature flows |
| QA / Validation | 2 | Experienced in CSV (computer system validation) but stretched |
| Security / IAM | 1 | Also supporting SOC2 renewal |
| Compliance / Quality | 2 | Owns SOPs, audit response, and vendor questionnaires |
| Product | 1 PM (you) | Accountable for scope, timeline, and stakeholder alignment |
Stakeholder Landscape (Competing Priorities)
- Orion Therapeutics (Customer Quality + Clinical Ops): Wants strong ALCOA+ evidence quickly—especially around audit trails, e-signatures, and data corrections. They care more about defensibility than new features.
- MedAxis Sales & Account Management: Pushing for a parallel roadmap item: a new “site performance dashboard” promised to Orion as part of renewal. They believe it’s needed to secure a $6.5M expansion.
- Engineering Director (Platform): Concerned about reliability and on-call burden; wants to avoid risky changes close to the audit window.
- Head of Quality/Compliance: Will not sign off on anything that isn’t traceable, validated, and procedurally controlled (SOPs, training, change control).
- CISO / Security: Prioritizes access controls and tamper resistance; insists on least privilege and immutable logging, but has limited bandwidth.
Current State (Where ALCOA+ Is Weak)
A pre-audit gap assessment found several issues:
- Attributable: Some data corrections are stored with a service account as the actor (background job), not the human user initiating the change.
- Contemporaneous: Mobile offline mode can submit forms hours later; timestamps are overwritten with server receipt time, not capture time.
- Original: “Source” PDFs for certain ePRO questionnaires are regenerated on demand; the exact original rendering at time of signature isn’t retained.
- Accurate/Complete: A retry bug in the ingestion pipeline can drop optional fields without failing the job; no reconciliation report exists.
- Consistent/Enduring/Available: Audit logs are split across two systems (Postgres table + vendor logging tool) with different retention (30 days vs 1 year). Export for auditors is manual and error-prone.
Constraints
- Timeline: 10 weeks until Orion’s FDA inspection; Orion wants remediation evidence in 8 weeks to include in their inspection binder.
- Budget: $180K available for external validation support and tooling; no new headcount approved.
- Change window: Engineering wants a code freeze 2 weeks before the inspection to reduce production risk.
- Uptime/SLA: Platform must maintain 99.9% uptime; no downtime migrations allowed.
- Regulatory expectations: Must support 21 CFR Part 11-aligned practices (e-signatures, audit trails) and demonstrate ALCOA+ principles in both system design and operational controls.
Your Task (Deliverables)
Produce a complete execution plan that addresses ALCOA+ data integrity principles under tight timelines and competing priorities. Specifically:
- ALCOA+ Remediation Roadmap: A prioritized backlog mapped to ALCOA+ categories (what you will fix now vs later), including explicit trade-offs and rationale.
- Launch & Validation Plan: A phased plan (design → build → test/validation → rollout) that fits the 10-week window and includes a code-freeze strategy.
- Audit-Ready Evidence Package: What artifacts you will deliver to Orion (e.g., audit trail samples, SOPs, validation summary, data lineage diagrams, access reviews) and who owns each.
- Risk Register + Mitigations: Top risks (technical, compliance, operational) with triggers and contingency plans, including a rollback plan for high-risk changes.
- Stakeholder Alignment Plan: How you will align Sales (dashboard commitment) with Quality/Engineering priorities—what you will say “no” to, what you will defer, and how you’ll communicate.
Complications (Realistic Curveballs)
- Key dependency slips: The vendor logging tool announces a breaking API change in 4 weeks; your team must either upgrade or decouple to keep audit exports working.
- Resource shock: One QA/Validation lead is pulled into an urgent customer escalation for 2 weeks, reducing validation capacity during your planned test window.
- Scope pressure: Sales escalates that Orion’s renewal decision is in 6 weeks and ties it to delivery of the site performance dashboard—asking you to “just squeeze it in.”
Your answer should demonstrate practical experience applying ALCOA+ principles to real systems: how you translate principles into concrete engineering work, validation artifacts, and an executable plan with measurable outcomes.
