Foundation Assessment & Q1 Outlook

What you'll walk away with

• Board- or leadership-ready Q1 Technology & Risk Outlook report
• Prioritized 12-month IT and cybersecurity roadmap
• Risk register keyed to pharma/biotech regulatory realities (GxP, 21 CFR Part 11, HIPAA)
• Baseline assessment of the existing MSP relationship

The problem this solves

Most small pharma and biotech companies reach a point where they have an MSP handling tickets and a stack of SaaS tools — but no one at the leadership level who owns technology strategy. MSPs answer support requests. They don't flag that your electronic signature process doesn't meet 21 CFR Part 11 requirements, or that a vendor contract renewal is quietly taking your backup coverage from daily to weekly. They don't show up at board meetings.

The problem isn't the MSP. The problem is the gap between "IT is running" and "IT is ready." Before committing to ongoing change, leadership deserves an honest baseline. What's actually in place? What's quietly broken? What would a board member or FDA auditor ask about your technology posture that you can't currently answer? This engagement answers those questions.

What the engagement looks like

The Foundation Assessment runs in three phases over 60 to 90 days. Everything is conducted virtually. On-site is available if the client covers travel.

Phase 1 — Discovery (weeks 1–4)

I start by talking to the people who know where the bodies are buried. That means structured interviews with leadership (CEO, CFO, COO), the internal POC for IT, and functional leads in R&D, clinical operations, regulatory affairs, and finance. I also run a formal data request to the MSP — account history, ticket volume, open items, licensing, and coverage scope — and review the vendor relationship independently.

Alongside the stakeholder work, I conduct an independent technology and security scan where appropriate: M365 tenant configuration, identity and access controls, endpoint posture, backup and recovery, and GxP-relevant data stores. The goal in this phase is raw data, not conclusions.

Phase 2 — Analysis (weeks 5–8)

I synthesize findings against two benchmarks: practical small-company IT best practices, and pharma-specific regulatory expectations — GxP data integrity, 21 CFR Part 11 audit trail requirements, HIPAA, and the control surface a company at your stage should have before an audit or commercial launch.

Every finding gets a risk rating: Critical, High, or Medium. I'm not looking to produce a 200-item list that nobody acts on. The deliverable is a prioritized picture of what matters most and why, with draft recommendations tied to each risk.

Phase 3 — Report and Presentation (weeks 9–12)

I draft the Q1 Technology and Risk Outlook report. After an internal review cycle with the client POC, I present it to the board or leadership team directly. You get the deck in PDF and editable source so you can use it in future board packages without starting over.

Who it's most useful for

• Pre-IPO or recently-public biotech that is facing its first real board-level technology conversation and doesn't yet have a credible answer
• Clinical-stage company preparing for commercial launch — when the IT infrastructure built for a 20-person team needs to survive a 90-person scale-up and its first FDA interactions
• Companies that have experienced an audit finding or near-miss and need to understand the full scope of exposure before fixing anything
• Leadership teams that have a nagging sense they've outgrown their MSP but can't articulate what's missing or where the risk actually lives

What you'll walk away with

The centerpiece is the Q1 Technology and Risk Outlook report. This is built to be presented — not filed away. It's structured so a CEO can walk a board or audit committee through it without needing me in the room, and so an auditor or investor could pick it up and understand your technology posture without a translation layer.

Alongside that, you get a 12-month IT and cybersecurity roadmap with sequenced priorities, a risk register grounded in GxP and 21 CFR Part 11 realities rather than generic IT frameworks, and an honest baseline assessment of your MSP relationship — what it's delivering, what it isn't, and whether the current arrangement still fits where the company is going.

Common questions

Do you replace our MSP? No. I evaluate the MSP relationship and give you an independent read on where it's working and where it isn't. Whether to replace, restructure, or stay the course is a separate conversation that follows from the findings. MSP replacement, if it comes to that, is a distinct engagement.

Do you need admin access to Microsoft 365? Read-only access is the ideal starting point — it lets me pull configuration data without touching anything. The specifics get worked out at kickoff. I'm not asking for global admin. Nothing invasive.

Will this satisfy a specific FDA or SOX audit requirement? Not directly. This is a diagnostic engagement, not a remediation one. It tells you what needs to be fixed and in what order. Meeting a specific regulatory requirement takes remediation work that follows this assessment — which is exactly why the report includes a prioritized roadmap.

What if we only want the report and no further engagement? That's a completely legitimate outcome. The Foundation Assessment is a fixed-scope engagement with a defined end. There's no expectation of continuing work, and no pressure to. You get the report, you own it, and you decide what to do with it.

Most effective alongside ongoing leadership

The Foundation Assessment frequently becomes the first quarter of a Fractional IT Leadership retainer. The report surfaces a roadmap — and someone needs to actually drive it. If the findings point to ongoing gaps in technology strategy, vendor oversight, or regulatory alignment, both the Advisory retainer and the Embedded retainer are structured to pick up exactly where this engagement ends.

Deliverables

• Q1 Technology & Risk Outlook deck (PDF + editable source)
• 12-month roadmap document
• Consolidated stakeholder interview summary
• Recommended next-quarter action plan