Are your digital systems truly audit-ready?
A short CSV & Data Integrity audit to secure your clinical and GxP systems before audits and inspections.
Why this matters
Pharma, Biotech, and HealthTech companies increasingly rely on digital tools in clinical and GxP environments.
However, many systems are:
• insufficiently validated (CSV)
• poorly documented
• not aligned with ALCOA+ and data integrity principles
• exposed to audit and inspection risks
Audit findings can lead to project delays, compliance issues, and loss of regulatory credibility.
The solution: CSV & Data Integrity Readiness Assessment
A short, structured, and pragmatic audit designed to assess the compliance of your digital systems and identify priority actions.
Duration: 2 weeks
Objective: clarity, compliance, and audit risk reduction
What you get
Review of 1 to 3 digital systems (CTMS, eTMF, eCRF, ePRO, eConsent, internal tools)
CSV, GxP, and ALCOA+ assessment
Identification of critical compliance gaps and audit risks
Actionable recommendations (quick wins and priorities)
1-hour debrief meeting
Concise PDF summary report
Who this is for
Companies scaling digital tools without dedicated internal CSV expertise
Clinical or GxP environments
Pharma, Biotech, and HealthTech companies
Organizations preparing for audits or inspections
Why work with me
Founder of Tech Conform, I bring:
• 6+ years of experience in digital project management for clinical research
• Certified expertise in Computer System Validation (ISPE)
• Strong experience in regulated environments (GxP, Data Integrity)
• Ability to translate complex regulations into practical, actionable solutions
• A pragmatic, risk-based approach focused on efficiency and compliance
Launch offer
Launch price: €590 (excl. VAT)
Standard price: €1,500 – €2,000
Limited availability to ensure quality delivery.
Ready to assess your audit readiness?
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