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Featured Content
- 20 minutes
The EU’s new Product Liability Directive (2024/2853) changes who can be held liable and what damages can be claimed. From software and data loss to wider supply chain liability, your insurance may not be enough. Discover the key changes and why reviewing your policy now is essential.
- 5 Minutes
A mid-sized pharmaceutical company embarked on a three-year digital transformation to validate TrackWise Digital across three sequential phases. See how full operational support within ValGenesis VLMS delivered end-to-end compliance, data integrity, and a scalable validation framework with minimal internal resource burden.
- 10 Minutes
As regulatory demands grow, even strong QA teams reach their limits. Here is how flexible QA support helps pharmaceutical companies manage change, reduce risk and keep GxP compliance on track, working alongside your team rather than replacing it.
- 10 Minutes
Rephine Barcelona S.L. is now accredited to ISO/IEC 17020 as an inspection body for specific GMP and GDP audit activities. We explain what the accreditation covers and why it matters when you rely on a third-party audit report.
- 20 minutes
Relying on historical cleaning limits or visual cleanliness checks to justify shared manufacturing carries more regulatory risk than many sites realise. Find out what a defensible Cross Contamination GAP Assessment actually covers, and how to start closing your own gaps.
- 10 Minutes
Every change to a validated system carries risk. Discover the core components, roles and best practices that keep Change Management in CSV projects controlled, compliant and audit-ready.
- 5 minutes
A global cosmetics manufacturer wanted to enter the OTC pharmaceutical market but had zero GMP experience. In 12 months, their Spanish production site achieved full 21CFR 210-211 compliance, passed FDA inspection readiness, and built lasting internal GMP capability.
- 20 minutes
Turn data integrity findings into a sustainable, risk based remediation plan. A practical 7 phase framework for pharma labs.
- 15 Minutes
Transport validation is a regulatory requirement under EU GMP Annex 15, yet many pharmaceutical companies still struggle with route selection and risk assessment. This guide walks you through a structured, compliant approach.