Leslie Cisneros

Validation & Qualification Specialist at QbD Group

Leslie is a Validation & Qualification Specialist at QbD Group, ensuring manufacturing equipment, systems, and processes meet GxP compliance standards.

6 articles

Jun 9, 2023 4 min

EudraLex Volume 4 Annex 11: compliance checklist and future prospects

This article addresses the latest revision of EudraLex Volume 4 Annex 11 and provides a checklist for compliance. Download it now.

Qualification & ValidationNov 15, 2022 6 min

Annual Product Quality Review (APQR / PQR) in Pharma: importance, benefits & challenges

Learn more about the importance, benefits, and key challenges related to Annual Product Quality Review in Pharma (APQR/PQR).

Software Solutions & ServicesOct 6, 2022 4 min

21 CFR Part 11 compliance checklist: does your system comply?

21 CFR Part 11 regulates the use of electronic records and signatures in pharma and MD. Download our 21 CFR Part 11 compliance checklist here.

Software Solutions & ServicesMay 3, 2022 2 min

Data migration in CSV: definition, purpose, and best practices

Sometimes it is necessary to perform data migration in computer systems, applications, or software. Learn more about the importance and risks.

Software Solutions & ServicesApr 5, 2022 4 min

What is decommissioning in CSV?

In CSV, decommissioning is the retirement or controlled shutdown of a computer system that is no longer needed. Learn more about this process.

Software Solutions & ServicesApr 26, 2021 5 min

10 things you should know before validating Computerized Systems

The steps you need to follow when you want to start validating a computerized system. Check these 10 steps!

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