Blog, page 5
Notes from our consultants on regulatory, clinical, quality, validation, IT and staffing topics.
Vakula Connect, Q4 2022: FDORA and planning for 2023
Our Q4 2022 update for consultants and clients: market signals, the roles in demand, and what was new at Vakula Technologies Inc.
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FDA publishes draft Computer Software Assurance guidance
The September 2022 draft guidance signalled a move from volume-driven CSV to risk-based assurance for production and quality system software.
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Vakula Connect, Q3 2022: CSA draft guidance and the shift to risk-based validation
Our Q3 2022 update for consultants and clients: market signals, the roles in demand, and what was new at Vakula Technologies Inc.
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Vakula Connect, Q2 2022: IVDR goes live; GxP cloud adoption accelerates
Our Q2 2022 update for consultants and clients: market signals, the roles in demand, and what was new at Vakula Technologies Inc.
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EU IVDR applies from 26 May 2022: what changed for diagnostics manufacturers
The In Vitro Diagnostic Regulation replaced the IVD Directive, moving most tests into notified-body review for the first time.
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Vakula Connect, Q1 2022: Trials restart and the validation crunch
Our Q1 2022 update for consultants and clients: market signals, the roles in demand, and what was new at Vakula Technologies Inc.
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ICH E8(R1): designing quality into clinical studies from the start
The revised General Considerations for Clinical Studies put quality by design and critical-to-quality factors at the centre of study planning.
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Vakula Technologies Inc is incorporated
In November 2021 Vakula Technologies Inc was formed in New Jersey to bring pharma and IT specialists to US life sciences and technology companies under one roof.
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