Data integrity and privacy risks are not limited to one team. They appear wherever regulated data is created, reviewed, moved or relied on, from quality and IT to labs, clinical, manufacturing and suppliers. 21 CFR Part 11 expects electronic records and e-signatures to stay trustworthy and controlled throughout.
This 90-minute webinar connects Part 11, EU GMP Annex 11 and EU GDPR with how SaaS, cloud hosting, remote access, integrations and vendor logins really work. It looks at the weak points FDA warning letters keep citing: excess admin rights, audit trails not enabled or not reviewed, gaps in lab data backup, and invalidated failed results without a sound root cause.
The aim is clear governance, clear controls and evidence you can defend in an inspection, without overbuilding your validation program.
Most data integrity and privacy failures come from everyday gaps in permissions, admin access, audit-trail review, reanalysis, exports and vendor access that build up until an inspection forces a costly cleanup. This session helps you spot them early and describe them in the terms regulators use.
It is especially useful for hybrid environments that mix local systems, SaaS, spreadsheets and vendor portals, helping QA, IT, validation, lab, regulatory, privacy and audit teams agree on practical controls and SOPs.
This webinar is designed for life sciences teams responsible for governing, validating, operating, or auditing computerized systems and regulated data—especially where electronic records/e-signatures, SaaS/cloud hosting, and privacy obligations intersect. Those include:
Most data integrity and privacy failures come from everyday gaps in permissions, admin access, audit-trail review, reanalysis, exports and vendor access that build up until an inspection forces a costly cleanup. This session helps you spot them early and describe them in the terms regulators use.
It is especially useful for hybrid environments that mix local systems, SaaS, spreadsheets and vendor portals, helping QA, IT, validation, lab, regulatory, privacy and audit teams agree on practical controls and SOPs.
This webinar is designed for life sciences teams responsible for governing, validating, operating, or auditing computerized systems and regulated data—especially where electronic records/e-signatures, SaaS/cloud hosting, and privacy obligations intersect. Those include:
Carolyn Troiano
Carolyn Troiano has more than 35 years of experience in computer system validation in the tobacco, pharmaceutical, medical device and other FDA-regulated industries. She has worked directly, or on a consulting basis, for many of the larger pharmaceutical and tobacco companies in the US and Europe. She is currently building an FDA computer system validation compliance strategy at a vapor company. Carolyn has participated in industry conferences, and is currently active in the Association of Information Technology Professionals (AITP), and Project Management Institute (PMI) chapters in the Richmond, VA area. Carolyn also volunteers for the PMI’s Educational Fund as a …
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