The eArchiving Initiative hosted an event back in May to celebrate the tenth anniversary of the first E-ARK project funded by the European Commission. During the…
The IRMS’ upcoming online event “MMU’s journey from shared drives to M365 – an update” will take place on Wednesday 10th July at 13.00 BST.…
A recent article published by Arkivum explains why the word “archived” is dangerous and poses risks to many modern businesses. The article looks at risk…
This short course aims to help learners with planning, building, and maintaining a Digital Asset Register, a key resource for managing the preservation of digital…
There’s still time to register for the 2024 AGXPE Conference, a pivotal event for quality and GxP training pros. Join the event from April 14-17, 2024…
HSRAA members might be interested in the forthcoming event on Microsoft 365 in Brighton on 15th May. Explore the potential of Microsoft 365 through an…
Sarah Hitching (Hedian Records Management and HSRAA Member) will be presenting at the 2024 CDISC + TMF Interchange in Berlin (24th – 25th April 2024)…
Arkivum have published a new eBook on “Achieving Long-Term Data Integrity Using Digital Preservation”. The eBook maps the ALCOA+ principles with self-assessment frameworks and maturity…
The EMA and the Heads of Medicines Agencies (HMAs) have published an artificial intelligence (AI) workplan to 2028, setting out a collaborative and coordinated strategy to maximise…
The Medicines and Healthcare products Regulatory Agency (MHRA) Inspectorate have posted a new blog post covering the extension of the validity date of GMP and…
Christina Mantzioros at Montrium has put together a blog piece that goes over how mock inspections can help your team, and the steps they would follow…
The Food and Drug Administration (FDA) have released a new guidance document. This draft guidance is not for implementation, it has been distributed for comment…
The Medicines and Healthcare products Regulatory Agency (MHRA) have released updated information and guidance on a range of medical devices for users and patients. Visit…
On 18-Jul-2023, Jamie Toth (HSRAA Chair) attended the MHRA GCP StEM in Canary Wharf, London. Karen Roy, CDISC TMF Reference Model Chair, also was in attendance…
The Medicines and Healthcare Regulatory Agency (MHRA) has released a statement on CE marking recognition for medical devices and in vitro diagnostics. Read in full HERE
The vision on Big Data is a strengthened regulatory system that can efficiently integrate data analysis into its assessment processes to improve decision making. Knowing…
ICH has published a new Reflection Paper: International Harmonisation of Real-World Evidence Terminology and Convergence of General Principles Regarding Planning and Reporting of Studies Using…
The OECD has published its Advisory Document on GLP & Cloud Computing – Supplement 1 to Document Number 17 on Application of GLP Principles to…
ICH recently released a new draft of the ICH E6 (R3) guidelines. While the finalised version is set for release at the end of 2023, we can…
As FDA considers the application of its risk-based regulatory framework to the use of AI technologies in drug manufacturing, it has identified in this discussion paper areas…
The MHRA has updated its published “Guidance on Borderline Products: How to Tell if your Product is a Medical Device and which Risk Class Applies”.…
Andrew Fisher, Lead Senior GCP Inspector, has written a blog about the changes to the International Council for Harmonisation (ICH) E6 Good Clinical Practice (GCP)…
This newly published European Medicines Agency ‘Questions and Answers Document’ provides answers to commonly asked questions about the proof-of-concept pilot on the submission and analysis…
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…
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…
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…
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 The documents…
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…
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…
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…
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…
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…
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…
The MHRA has published its GCP Inspections Metrics Report covering the period 1st April 2019 to 31st March 2020. Perhaps of interest to HSRAA members are…
This guideline (which replaces EMA/INS/GCP/454280/2010 Reflection Paper on Expectations for Electronic Source Data and Data Transcribed to Electronic Data Collection Tools in Clinical Trials) describes some…
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Each year the HSRAA is invited to represent the views of archivists at the MHRA GLP StEM (Stakeholder Engagement Meetings). The 2022 StEM will take…
Raw data in electronic structured format is currently not systematically included as part of marketing authorisation and variation applications submitted to EMA. However, the Regulations…
The latest edition of the EMA Clinical Trials Information System (CTIS) Newsletter provides insights on clinical trials topics. Of particular interest to HSRAA members is…
The EMA Big Data Steering Group set up by EMA and the Heads of Medicines Agencies (HMA) has published its third workplan that sets key actions to be delivered between 2022–25. For more…
The use of Adobe Sign for creating and managing GxP e-signatures is increasingly sought after by pharmaceutical and healthcare organisations. In this blog, Gianna de Rubertis…
Arkivum has revised and updated its interactive guide to eTMF and clinical data archiving and preservation. Not only is it packed full of expert insights, great tips and…