News - Health Sciences Records and Archive Association

Digital Preservation Coalition: Digital Preservation Policy Toolkit 2.0

Posted on April 28, 2023April 28, 2023 by Administrator

An updated version of the DPC’s Preservation Toolkit has been shared, which improves the previous version by building on the work and feedback of their community. This toolkit offers information and resources to help you understand more about digital preservation...Read More

Technology Focus: UK National Cyber Security Centre Warns of Dangers of ChatGPT

Posted on April 28, 2023April 28, 2023 by Administrator

Artificial Intelligence writers and chatbots have seen huge success following a boom started by ChatGPT since its launch in November 2022. As ChatGPT grows so too does the scepticism. Such Large Language Models (LLMs), may improve efficiency and harness creativity...Read More

Montrium Blog “From Archivists to Strategists: The New Role of the TMF Manager”

Posted on April 28, 2023April 28, 2023 by Administrator

It’s unlikely that Bob Dylan was writing about the trial master file in his 1964 hit song, “The Times They Are a-Changin". And yet, 59 years later, one could argue that it’s become a fitting anthem for the state of...Read More

NEW PIC/S Good Distribution Practice Guidance Documents

Posted on April 28, 2023April 28, 2023 by Administrator

The Pharmaceutical Inspection Co-operation Scheme (PIC/S) has published two new Good Distribution Practice (GDP) guidance documents that came into force in Feb 2023 PI 044-1 ‘Aide-Memoire on the Inspection of Good Distribution Practice for Medicinal Products in the Supply Chain’...Read More

FDA Bioresearch Monitoring (BIMO) Inspection Metrics 2022

Posted on April 28, 2023April 28, 2023 by Administrator

The FDA has released its BIMO inspection metrics for year 2022. These metrics give you useful information on inspections performed throughout 2022 and observations raised (compared to previous years). With more inspections due to be conducted this year, get inspection...Read More

MHRA Blog “Manufacture of Investigational Medicinal Products – Frequently Asked Questions”

Posted on April 28, 2023April 28, 2023 by Administrator

GMP and GCP Inspectors work closely with MHRA Clinical Trials and regularly provide support to help answer a wide range of stakeholder queries which relate to the manufacture, import, labelling, licencing requirements and general handling of Investigational Medicinal Products (IMPs)....Read More

EU Extension of Medical Device Regulations Transitional Period

Posted on April 28, 2023April 28, 2023 by Administrator

The EU is introducing more time to certify certain medical devices under EU Medical Device Regulation (“EU MDR”). The proposal recognises the challenges in capacity across notified bodies. More information regarding the impact of this extension can be found HERE.

MHRA Blog “Large Language Models and Software as a Medical Device”

Posted on April 28, 2023April 28, 2023 by Administrator

Large Language Models (LLMs), including ChatGPT and Bard, offer great potential to mimic human conversation. LLMs only directed toward general purposes and whose developers make no claim that the software can be used for a medical purpose are unlikely to...Read More

ECA Publishes New Guide “A Road Map to GMP Compliant Equipment Design”

Posted on April 28, 2023April 28, 2023 by Administrator

The ECA has published a new guide to illustrate the generally applicable requirements for the design of GMP equipment and to explain how the connection between design and the statement “produced in compliance with GMP” can be made. It contains...Read More

NEW MHRA Guidance: Crafting an Intended Purpose in the Context of Software as a Medical Device

Posted on April 28, 2023April 28, 2023 by Administrator

Products classified as medical devices must demonstrate they meet the requirements of UK Medical Devices Regulations. The purpose of these regulations is to ensure the benefits of a product outweighs the risks, so that UK citizens have access to safe...Read More

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