Neeru Bakshi has more than with 20 years’ experience in the pharmaceutical and Life Sciences domain. She worked as Validation/QA Lead, Project Manager/Lead, and as Business Analyst for various cloud solutions and systems such as Oracle Life Sciences Applications for Clinical Trails, SAP, GLP systems, Electronic Submissions, Pharmacovigilance Systems.
Neeru is well versed in regulatory standards and guidelines; 21 CFR Part 11, Computer System Used in Clinical Trials, GAMP5 guidelines, EudraLex Volume 4 Annex11 along with knowledge of European data protection laws and practices and understanding of the GDPR. She has experience and interest executing
harmonization, development and implementation of Global Quality and IT/CSV Policies/ SOP’s/ Guidelines across the organization level. She also has experience in
the pharmaceutical industry audits of validated computer systems, and supporting clients in such pharmaceutical industry audits, whether they be internal audits,
sponsor-driven audits, or regulatory agency audits.
At present Neeru Bakshi is Founder of Tech Qualitas organization where team aims to provide the pharmaceutical, biotech, medical device, CRO and other regulated
companies by providing compliant outsourced services such as for Computerized System Validation, Customized Software Solution, SOP Development & Implementation, Information Technology Services, Audit, Compliance and Data Integrity Support, IT vendor audits on behalf of regulated company, SaaS product
validation to improve performance, data integrity, privacy controls, and compliance.