Professional focus
Digital Quality, Computerized Systems Assurance, and Responsible AI in Regulated Life Sciences.
Author and editorial lead
Sandip Thorat
Digital Quality and Computerized Systems Assurance Leader
Sandip develops practical guidance, research and software tools for computerized systems assurance, AI-enabled quality systems and regulated digital systems.
His work focuses on intended use, functional risk assessment, risk-based testing, supplier assessment, and maintaining the validated state.
His public professional profile describes more than 15 years of work across GxP and non-GxP software quality and compliance. This site presents independent practitioner work and does not represent an employer or client.
Areas of expertise
- Risk-based computerized systems assurance
- SaaS, supplier, interface, and migration assessment
- Electronic records, audit trails, and data integrity
- AI-enabled GxP systems and human review
- Risk-based testing and traceability
Research interests
- Maintaining the validated state for continuously changing systems
- Supplier assessment and use of supplier test results
- AI use controls for probabilistic systems
- AI-assisted document review
- Validation rationale and inspection readiness
Education and certification
- Master’s degree in Pharmacy
- CRISC — Certified in Risk and Information Systems Control, ISACA
Based on Sandip’s verified public LinkedIn profile. Institution, dates, and credential identifiers are omitted until source documents are approved for publication.
Selected public work
Validating the Future
A five-part practitioner series on continuous validation, generative AI, autonomous quality systems, and algorithmovigilance.
- Part 1From Simulation to Reality: Why AI Systems Need Continuous Validation ↗
- Part 2The Evolution of Validation for Intelligent Systems ↗
- Part 3How Generative AI Is Beginning to Transform Testing Itself ↗
- Part 4Continuous Validation & Autonomous Quality Systems ↗
- Part 5Algorithmovigilance: How to Monitor and Control AI Systems in the Real World ↗
Content governance
Editorial Method and Independence
Source hierarchy
Binding text and primary issuing-authority material come first. Guidance, standards, industry practice, and professional interpretation are labeled distinctly.
Technical review
Technical pages identify author, publication and review dates, version, scope, limits, references, correction route, and AI-use disclosure where applicable.
Independence
CSV to CSA is a practitioner-led educational platform. No employer, client, regulator, supplier, or professional body endorsement is implied.
Professional record governance
Only claims supported by an approved public source are displayed. Institution and graduation details, credential verification, memberships, awards, speaking records, completed peer reviews, ORCID, Google Scholar, biography, and CV remain unpublished until Sandip supplies and approves their source records.
Professional inquiry