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The industry is looking at utilising available tools and technologies to be efficient and provide more accurate and reliable data in support of the regulatory requirements, eventually working towards data-backed information for the medical fraternity and the public. Blockchain offers a decentralised, uniformly distributed node-based database that protects data security and transparency. With the help […]

The process of performing audits has undergone a significant transition in our constantly changing digital age, where technology is changing how we work and interact. The concept of virtual audits was created because of this transformation’s increased reliance on digital tools and remote labour capabilities. These virtual audits have become a powerful and essential tool

The new UK Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024 introduce new requirements for manufacturers of medical devices in Great Britain. These requirements are designed to ensure that medical devices continue to be safe and effective throughout their lifetime. The 2024 amendment introduces a new Part 4A to the UK Medical Devices

Auditing of safety databases can be a complex proposition for many of us. Assessing safety requirements is one major part of it; the added complexity of understanding the database build, the technology involved and the controls around it are the other major part of the audit. It requires a balance between understanding safety requirements and

As the CEO of a small but dedicated quality assurance consultancy serving the life sciences industry, I’m often reminded that “quality” is more than a buzzword or compliance requirement — it is a philosophy, a culture, and, most importantly, a shared responsibility. Whether you’re producing groundbreaking therapies, essential medical devices, or innovative diagnostic tools, quality

Inspection readiness is the state of being always prepared for a regulatory inspection (and audits). Achieving a favourable outcome from an audit, and especially a regulatory inspection, demonstrates compliance with the applicable GxP regulations of that organisation. Therefore, being ready to successfully host inspections shows that not only does an organisation understand the regulatory applicable

Ensuring a state of perpetual inspection readiness is crucial for ensuring compliance with Good Practice (GxP) regulations. These guidelines, which include Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), and Good Clinical Practice (GCP), are designed to safeguard product quality and patient safety. Inspection readiness is not just a regulatory requirement; it is a cornerstone

In the pharmaceutical industry, meticulous audits are not just a regulatory necessity but a cornerstone of trust and safety. Ensuring the highest standards of quality, safety, and efficacy in drug manufacturing and development is paramount to public’s health and the business’s reputation. Audits play a critical role in maintaining these standards by systematically examining the