Decades of Validation Experience. Built on Regulatory Precision.
Lee W Page Validation Associates LLC was founded on a single principle: validation documentation should be written to survive an FDA inspection, not just satisfy an internal checklist.
Lee W. Page
Principal Consultant & Founder
Areas of Expertise
- Computer System Validation (CSV) — GAMP 5 lifecycle methodology
- Equipment Qualification — IQ/OQ/PQ across pharmaceutical manufacturing environments
- FDA 21 CFR Part 11 — electronic records and electronic signatures compliance
- GxP Documentation — VMPs, SOPs, risk assessments, and audit-ready deliverables
- Regulatory frameworks: FDA, EMA, ICH Q10, GAMP 5, USP, cGMP
- Pre-inspection audit support and mock FDA inspection preparation
Lee W. Page brings decades of hands-on experience in computer system validation and equipment qualification to pharmaceutical manufacturers, biotech firms, and medical device companies across the industry.
His career spans the full validation lifecycle — from authoring Validation Master Plans and qualification protocols to leading pre-inspection documentation audits and supporting firms through FDA investigations. He has worked across a broad range of GxP-critical systems and manufacturing environments, developing a practical understanding of what regulators expect and what documentation actually holds up under scrutiny.
Lee founded Lee W Page Validation Associates LLC to provide pharmaceutical and biotech clients with senior-level validation expertise on an engagement basis — the kind of rigorous, experienced perspective that is difficult to maintain in-house but critical when compliance is on the line.
Validation That Holds Up
The purpose of validation is not to generate paperwork — it is to provide documented evidence that a system or process does what it is supposed to do, consistently and reliably. Every deliverable we produce is written with that standard in mind.
No Generic Templates
Every validation protocol and report is authored to the specific system, equipment, and regulatory context of your facility. Generic templates produce generic documentation — and generic documentation fails inspections.
Risk-Based Scoping
Validation effort should be proportional to GxP criticality. We apply formal risk assessment to every engagement to ensure resources are focused where they matter most — and documented in a way regulators recognize.
Inspection-Ready by Default
We write every document assuming an FDA investigator will read it. Clarity, traceability, and completeness are not optional — they are the baseline standard for every deliverable we produce.
Practical Compliance
Regulatory compliance must be operationally sustainable. We design validation approaches that meet current regulatory expectations while remaining practical for your team to maintain and defend over time.
Frameworks We Work In
FDA 21 CFR Part 11
Electronic records and electronic signatures
GAMP 5
Risk-based approach to compliant GxP computerized systems
ICH Q10
Pharmaceutical quality system lifecycle model
EU Annex 11
Computerized systems in GMP environments
USP <1058>
Analytical instrument qualification
FDA Process Validation Guidance
Stages 1–3 process validation lifecycle
Work With an Expert Who Knows What Regulators Expect
Whether you need a single qualification protocol or a complete validation program, we bring the experience and rigor your compliance program requires.