Validation, CSV and data integrity consultants
Computer system, equipment and process validation that stands up to an inspector rather than a checklist.
The problem we solve
Validation that was done to pass an audit fails the next one.
Templates copied from the last project, test scripts that never exercised the risky functions, Part 11 assessments that nobody could defend line by line. The paperwork looks complete until an inspector asks why.
Vakula validation consultants work risk-based, from GAMP 5 categorisation and requirements through to traceable test evidence, and they document the reasoning so your own team can defend it later.
Tell us what you need
A consultant replies, not an auto-responder. Typical response inside one business day.
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What we do
Validation & CSV capabilities
Computer system validation
Validation planning, URS/FRS, risk assessment, IQ/OQ/PQ and traceability for LIMS, eQMS, ERP, MES, CTMS, EDC and cloud SaaS.
21 CFR Part 11 and Annex 11
Gap assessments, remediation plans and periodic reviews for electronic records and signatures.
Data integrity
ALCOA+ assessments, audit trail review procedures and remediation.
Equipment and process validation
Commissioning, qualification and process validation for manufacturing and laboratory equipment.
Cleaning and method validation
Protocols, execution support and reports.
Validation programme management
Managed validation teams under SOW for system roll-outs and site start-ups.
How an engagement runs
What happens after you contact us
Intake call
A consultant who works in this function takes the brief: scope, systems, regulatory context, timeline and budget band. Same day where possible.
Proposal and people
Within a few business days you get a written scope or a shortlist of named consultants with availability and rates. No generic CVs.
Kick-off under a clear SOW
Deliverables, acceptance criteria, reporting cadence and escalation path are agreed in writing before work starts.
Delivery with oversight
A Vakula engagement lead stays accountable for quality and continuity, including cover if a consultant rolls off.
Questions
Before the first call
Do you validate cloud and SaaS systems?
Yes. Supplier assessment, shared-responsibility mapping and a risk-based test scope are the core of our approach to SaaS validation.
Can you help us move to computer software assurance (CSA)?
Yes. We help clients adopt FDA's CSA thinking to focus testing on risk while keeping the evidence regulators expect.
Do your consultants write and execute?
Both. We also supply execution-only testers for large test campaigns.
Which industries?
Pharmaceutical, biotechnology, medical device and diagnostics manufacturers, CDMOs and CROs.
Related
Adjacent services
Start with one requirement.
Send us a role, a scope or a problem. We come back with a plan and a named consultant, not a sales deck.