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Discover strategies to optimize and maintain a Pharmacovigilance QMS in 2025, ensuring global compliance, efficiency, and patient safety across diverse […]

In June 2025, the FDA announced the availability of a final guidance document containing questions and answers on conducting remote

Quality Assurance (QA) teams play a critical role in ensuring compliance, maintaining regulatory integrity, and continuously improving organizational performance. However,

The pharmaceutical industry is subject to stringent regulations that demand strict adherence to quality standards to ensure the safety and

The industry is looking at utilising available tools and technologies to be efficient and provide more accurate and reliable data

The process of performing audits has undergone a significant transition in our constantly changing digital age, where technology is changing

The new UK Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024 introduce new requirements for manufacturers of medical

Auditing of safety databases can be a complex proposition for many of us. Assessing safety requirements is one major part

As the CEO of a small but dedicated quality assurance consultancy serving the life sciences industry, I’m often reminded that

Inspection readiness is the state of being always prepared for a regulatory inspection (and audits). Achieving a favourable outcome from