GxP & 21 CFR Part 11 IT Readiness

What you'll walk away with

• GxP-scoped IT posture assessment
• 21 CFR Part 11 compliance gap analysis (access, audit trails, e-signatures, data integrity)
• Prioritized remediation roadmap with regulatory severity rating
• Evidence package usable during FDA inspection or client audits

The problem this solves

GxP environments carry IT requirements that generic MSPs have never been asked to think about. Under 21 CFR Part 11, electronic records need protected audit trails, electronic signatures must meet specific technical criteria, and access to GxP data must be documented, reviewed, and revocable. Data integrity isn't a policy aspiration — it's something an FDA investigator will test.

MSPs patch servers and manage endpoints. They don't assess whether a user's access to the clinical data platform is documented and reviewed, whether your eTMF produces a compliant audit trail, or whether your LIMS validation status holds up. FDA inspectors and sponsor auditors ask those questions. This engagement closes the gap between "IT is operational" and "IT is auditable."

What the engagement looks like

Four phases over six to ten weeks. Everything delivered virtually.

Weeks 1–2: Scope. I map GxP data flows and identify in-scope systems — eTMF, LIMS, QMS, manufacturing execution, clinical data platforms — confirm data owners, and establish which regulatory frameworks apply.

Weeks 3–5: Assessment. I assess each in-scope system against 21 CFR Part 11: access provisioning, audit trail configuration, electronic signature implementation, data integrity controls, change control, and validation posture from the IT angle. I'm not reviewing SOPs — I'm checking whether the infrastructure supporting them holds up.

Weeks 6–8: Roadmap and evidence. I draft a remediation roadmap ranked by regulatory severity — framed around whether each gap would survive an inspection — and assemble an initial evidence package: access reviews, audit-trail samples, and validation artifacts ready to hand over if an inspection is called.

Weeks 9–10: Handoff. Walkthrough with quality and regulatory leadership, then handoff to whoever owns ongoing compliance — in-house quality, a compliance partner, or a retainer.

Who it's most useful for

• Clinical-stage biotech with GxP data in M365, SharePoint, or SaaS but no IT-side compliance posture
• Commercial pharma preparing for an FDA or MHRA inspection
• Companies that received a 483 observation or audit finding with an IT-side component
• CROs whose sponsor clients are increasingly auditing IT as part of qualification

What you'll walk away with

A gap analysis covering each in-scope system with per-system status, a remediation roadmap sequenced by regulatory severity, and an evidence package built to hand to an inspector — not assembled under pressure the week one shows up.

This is an IT-side read. It partners with your QA function rather than replacing it. QA owns the SOPs and validation strategy; I cover the IT controls that determine whether those systems are auditable.

Common questions

Are you a QA consultant? No. I'm the IT-side counterpart. QA owns the SOPs, validation protocols, and quality system. I cover the IT controls — access management, audit trail configuration, electronic signatures — that determine whether those systems hold up under scrutiny.

Do you handle the remediation or just the assessment? Both — either within this engagement or carried into a retainer. You won't walk away with a gap list and no path forward.

Can this satisfy a sponsor audit? It prepares you to pass one. The evidence package and remediation work put your IT posture in a defensible position. Audit responses happen at the audit — this makes sure you're ready.

Most effective alongside ongoing leadership

GxP compliance isn't a one-time project. Access reviews happen quarterly, new systems need to be scoped before going live with regulated data, and audit trails don't monitor themselves. That steady operational rigor fits a Fractional IT Leadership retainer. Both the Advisory retainer and the Embedded retainer are structured to carry this work forward.

Deliverables

• GxP IT assessment report
• 21 CFR Part 11 control checklist with per-system status
• Remediation roadmap
• Evidence package (access reviews, audit-trail samples, validation artifacts)