GxP · Pharma · MedTech · Biotech

Validation for Compliance.
Built for Patients.

Senior, independent CSV and digital assurance for regulated organisations navigating SaaS adoption, AI governance and inspection pressure without the overhead of a large consultancy.

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Regulatory Frameworks
GAMP 5 · CSA · 21 CFR Part 11
EU Annex 11 · ALCOA+
Engagement Approach
Senior-only delivery.
Every engagement, senior-led.
Experience
25+ years across pharma,
biotech & medical devices.
Based In
London, UK,
operating globally.
25+
Years GxP Experience
40+
Systems Validated
2015
Founded
ISO 9001
Qualified Auditor
SaaS Platform Go-Live
FDA / MHRA Inspection Prep
AI in Regulated Workflows
Audit Finding Remediation
Data Integrity Programme
Part 11 / Annex 11 Assessment
The Problem

Most regulated teams are one inspection away
from an evidence problem.

Compliance functions are under pressure. Systems are being deployed faster than governance frameworks can keep pace. The gap between what regulators expect and what organisations can demonstrate is widening.



That's where Analytica Validation works in the space between operational reality and inspection defensibility.

01
SaaS platforms deployed without a defensible validation strategyVendor SOC 2 reports don't satisfy GxP expectations. Supplier oversight needs active governance.
02
AI tools entering regulated workflows with no governance frameworkRegulators are watching. Risk classification, change control and evidence trails are now expected.
03
Audit observations that expose evidence gaps at the worst timeRemediation under inspection pressure is expensive, disruptive and entirely avoidable.
04
Compliance work that stops at go-live instead of sustaining through BAUValidated systems drift. Controls need to be designed to last, not just to pass.
Who You're Working With
Ashok Bangher — Principal Consultant, Analytica Validation
Founder & Principal Consultant
Ashok Bangher
CSV · Data Integrity · Digital Assurance

Founder Ashok Bangher has spent over 25 years working across pharma, biotech and MedTech organisations including GSK, Lonza Biologics, Smith & Nephew and Dechra, and has seen what happens when regulated systems are deployed without proportionate governance, and what it takes to fix it before an inspector does.

Analytica Validation was built on a simple premise: senior expertise shouldn't come with large-consultancy overhead. Every engagement is directed and delivered by our Principal Consultant, bringing that same depth of hands-on GxP experience to your systems, your risk profile and your inspection readiness.

GAMP 5 21 CFR Part 11 EU Annex 11 ALCOA+ CSA Principles SaaS Governance ISO 9001 ICH Q7A
Core Services

Targeted expertise.
Defensible outcomes.

01
Computerised System Validation

Lifecycle strategy, validation planning, testing oversight and reporting, CSA-aligned, traceable and inspection-defensible.

↗ 02
Data Integrity

ALCOA+ assessments, remediation planning and sustainable BAU control design across the data lifecycle.

↗ 03
21 CFR Part 11 / EU Annex 11

Applicability decisions, gap assessments and evidence packs built for inspection scrutiny, not just internal sign-off.

↗ 04
SaaS Governance

Supplier oversight, change governance, periodic review and operational controls for regulated SaaS platforms.

↗ 05
Cybersecurity for Regulated Environments

Security controls aligned with assurance and auditability, supporting validation rather than competing with it.

↗ 06
Inspection Readiness

Readiness assessments, evidence narrative and targeted remediation support designed to reduce inspection friction.

↗ 07
Audit & Supplier Oversight

ISO 9001-qualified internal audit capability: supplier qualification, CSV package audits, FDA 483 response and CAPA ownership across regulated life sciences.

↗ 08
AI Governance

Validation strategy, change control and inspection-ready evidence for AI and algorithmic systems in regulated environments. Emerging requirements. Proven principles.

↗
Client Outcomes

What clients say
after working together.

These represent the kinds of outcomes Analytica Validation delivers: inspection confidence, evidence clarity and compliance programmes that hold up when it matters.

Ashok played a central role in establishing our Quality Management System from the ground up,creating the procedures, governance framework and quality oversight required for a regulated software organisation. He also led the computerised system validation of our genome-editing analysis software. The validation strategy and documentation he developed were thorough, well-structured, and proved to withstand customer audits and regulatory scrutiny.

Jelle ten Hoeve · Co-Founder, Data Curators BV

Ashok provides high-quality validation expertise and supports the team to get things done right first time, going the extra distance to ensure conflicts are resolved effectively and with common understanding.

Brian Long · Client, Dotmatics

During years of collaboration with Ashok I was impressed by his very extensive knowledge in CSV and automation. He was an active member of the team, always ready to help, and delivered every project on time and to a high standard.

Rosita Tsiagkana · Data Integrity & Compliance Manager
How We Work

Structured. Pragmatic.
Built around your environment.

01
Strategic Call

A no-obligation conversation to understand your environment, your systems and where the risk actually sits. No charge.

02
Scope & Readiness Assessment

If scope isn't yet clear, a fixed-fee assessment establishes GAMP category, boundary and risk position before you commit further.

03
Scoped Proposal

A clear, fixed-scope proposal: no vague retainers, no scope creep, no surprises. You know what you're getting before we start.

04
Senior-Led Delivery

Work is directed and delivered by our senior consultant throughout, so the expertise you engaged is the expertise applied from day one to sign-off.

05
Inspection-Ready Output

Deliverables designed to hold up under scrutiny with clear rationale, traceable evidence and sustainable BAU controls.

From the Insights

Practical thinking on
validation and compliance.

PERIODIC REVIEW
CSV Periodic Review: What It Covers and Why It Gets Skipped

The most consistently skipped step in CSV programmes, what annual review actually involves and where the quiet drift happens.

Read → INSPECTION READINESS
Mock Inspections: What Internal Review Cannot Find

A mock inspection run six weeks before an FDA PAI. What it revealed that internal review had missed entirely.

Read → CSV PLANNING
Five Questions to Ask Before Any Validation Begins

If any of these five questions go unanswered at the start, scope will drift. The answers should exist before testing begins.

Read →
View all insights →
Stay Informed

Regulatory updates and
practical validation guidance.

Occasional notes on inspection trends, regulatory changes and CSV practice. No sales content. Unsubscribe any time.

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An inspection isn't a surprise.
Being unprepared is.

Book a 30-minute strategic call. No commitment, no sales process, just a direct conversation about your environment.

"The validation strategy and documentation proved to withstand customer audits and regulatory scrutiny."

Jelle ten Hoeve · Co-Founder, Data Curators BV
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