About

Senior expertise.
Delivered directly.

Analytica Validation Limited is a UK-registered specialist consultancy. Every engagement is scoped and directed by our Principal Consultant, underpinned by a senior-led delivery model that keeps experienced GxP judgement applied consistently from first conversation to final sign-off.

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Principal Consultant

Ashok Bangher

Founder · CSV · Data Integrity · Digital Assurance

With over 25 years working across pharmaceutical, biotech and medical device environments; including extended engagements at GSK, Lonza Biologics, Smith & Nephew and Dechra, Ashok brings a depth of regulatory context most consultancies cannot match at Principal-Consultant level.

Analytica Validation was built on one principle: organisations in regulated industries deserve senior expertise applied directly to their problem, not filtered through layers of account management or delegated to less experienced staff. It is a deliberate operating model, not a limitation.

GAMP 5 21 CFR Part 11 EU Annex 11 ALCOA+ CSA Principles SaaS Governance ISO 9001 Auditor ICH Q7A ISO 13485 FDA 483 Resolution Supplier Auditing CAPA Management

Audit & Inspection

Both sides
of the audit table.

As a qualified auditor with over 25 years operating in FDA and MHRA regulated environments, the audit perspective is embedded in every engagement, not added as an afterthought. From supplier qualification to FDA 483 resolution, the approach is always the same: evidence-led, risk-proportionate and defensible.

Supplier & Vendor AuditingRisk-based supplier assessment and qualification. Audit procedures, evaluation frameworks and ongoing oversight designed to satisfy both internal QA teams and external inspectors.

Internal CSV & QMS AuditsSystematic review of CSV packages, IT procedures and documentation against GAMP 5, 21 CFR Part 11 and EU Annex 11. Non-conformities identified and driven to corrective action closure.

FDA 483 Response & CAPA ManagementStructured response to observations, CAPA ownership and efficiency improvement. Every response is documented, traceable and aligned to what the agency needs to see.

Data Integrity AuditDI risk assessment across computerised systems and associated business processes. Identifies gaps, formulates mitigation strategies and embeds sustainable controls, proven at scale across multi-site manufacturing environments.

Pre-Inspection ReadinessGap analysis, mock audit facilitation, evidence narrative preparation and back-room inspection support, so the evidence is in order before the inspector arrives.

Our Approach

Pragmatic assurance.
Not bureaucracy.

Every engagement is structured around intended use, system criticality and data integrity risk. The result is one coherent assurance narrative documenting decisions that are explainable and evidence that is inspection-ready.

DefensibilityTraceability and recorded rationale that withstand audit and inspection scrutiny, not just internal sign-off.

ProportionalityAssurance scaled to system criticality and intended use. Not every system needs the same approach; treating them identically wastes resource and obscures risk.

SustainabilityControls designed for BAU so compliance is maintained after go-live. Validated systems drift, and governance is designed to prevent it.

ClaritySimple governance, predictable delivery and evidence you can retrieve quickly when an inspector asks for it.

Sectors

The environments
we work in.

Pharmaceutical manufacturing and quality, including large global organisations operating under FDA, MHRA and EMA scrutiny.

Pharma · GMP · Inspection-regulated

Biotech and CDMO environments deploying cloud, SaaS and bespoke platforms in GxP-regulated manufacturing and quality workflows.

Biotech · CDMO · SaaS-heavy

Medical device organisations managing CSV, data integrity and electronic records obligations across ISO 13485 and 21 CFR Part 820 environments.

MedTech · ISO 13485 · Part 820

What colleagues say

Working with Ashok.
In their own words.

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

Ashok consistently demonstrated both flexibility and deep expertise, while always taking a pragmatic, risk-based approach to decision-making. We worked together on several systems including the Tecan ELISA robotic automated system and a number of IT quality remediation activities. I would happily work with him again and would highly recommend him.

Laur Oltean · QA/CSV Consultant · LRQA Lead Auditor ISO 9001:2015

Senior expertise.Delivered directly.

Both sidesof the audit table.

Pragmatic assurance.Not bureaucracy.

The environmentswe work in.

Working with Ashok.In their own words.

Direct access.Senior expertise, applied.

Senior expertise.
Delivered directly.

Both sides
of the audit table.

Pragmatic assurance.
Not bureaucracy.

The environments
we work in.

Working with Ashok.
In their own words.

Direct access.
Senior expertise, applied.