Gabriel Buta

Horaxis
Founder
Gabriel Buta is the founder of Horaxis, a software company building risk-management and supply-chain platforms for regulated industries. He writes on the technical implementation of GxP-relevant patterns in computerized systems. Based in Europe, reachable at info@horaxis.com or via LinkedIn.

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iSpeak Blog
From Component to Patient: Keeping Pharmaceutical Supply Continuous Through Regulatory Transitions

Regulatory transitions, product re-registration, marketing-authorization transfers, site changes, Medical Device Directive (93/42/EEC) (MDD)-to- Medical Device Regulation (EU 2017/745) (MDR) migration, open a foreseeable supply-continuity gap: a product can no longer ship under its old regulatory basis but not yet under its new one. The usual response, a flat "three months of bridging stock...

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iSpeak Blog
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For a clause that has been in force since 1997, 21 CFR Part 11 §11.10(e) is still remains one of the most under-implemented requirements in computerized GxP systems. Many quality and information technology (IT) teams reduce it to a single compliance checkbox: "we log who changed what, with a timestamp—done." But when an inspector looks beyond that surface-level interpretation, the gaps quickly...