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What to expect when being expected

What to expect when being inspected?

Ever wonder what happens during a regulatory inspection? Let’s dive into what to expect, from the inspector’s arrival to the post-inspection. Learn how to prepare for a smooth inspection and avoid unnecessary anxiety.

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Post-Market Success under IVDR: Prioritizing PMS & PMPF

As the IVD industry undergoes significant regulatory changes with the implementation of Regulation (EU) 2017/746 (IVDR), manufacturers are facing new challenges and requirements regarding post-market surveillance (PMS) and post-market performance follow-up (PMPF). In this article, we explore the importance of prioritizing PMS and PMPF under the framework of the IVDR.

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How to avoid non-compliance

How to avoid non-compliance in the pharmaceutical industry

This blog underscores the critical nature of regulatory compliance in the pharmaceutical industry. It stresses the importance of senior management’s commitment despite significant costs. Key elements like Corrective Action Preventive Action (CAPA) plans are highlighted, especially with the trend towards computerized solutions. Non-compliance risks severe financial consequences, necessitating proactive measures. Effective compliance programs encompass written procedures, designated personnel, training, communication, and monitoring. Compliance is increasingly seen as a strategic advantage rather than just a cost-saving measure.

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Computer Software Assurance (CSA) in Pharma Industry First Steps to move from CSV to CSA) 

Computer Software Assurance (CSA) in Pharma Industry: First Steps to move from CSV to CSA 

In this blog post, we explore Computer Software Assurance (CSA), a modern alternative to traditional Computer System Validation (CSV), focusing on its crucial role in the pharmaceutical industry. Discover the key differences between CSA and CSV, the initial steps for transitioning from CSV to CSA, and why the CSA approach is increasingly important for ensuring system reliability, security, and compliance in drug development and manufacturing.

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Automated software testing for the GxP world - QbD Group

Automated software testing for the GxP world

Struggling with CSV validation and testing automation? Tired of re-validating at every sprint? Discover expert tips to reduce time, and budget, and increase validation coverage in our latest blog post on automated software testing for the GxP world.

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UK’s Medicines Regulator Announces IT Roadmap

UK’s medicines regulator announces IT roadmap

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) is developing a new IT system to streamline submissions related to product licensing and process licensing. The first release of the system is expected by the end of 2023, with subsequent releases incorporating wider elements such as medical devices and import notifications. An agile delivery model will enable continuous improvement based on user feedback.

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7 key areas to focus on during internal or supplier audits 

Regulatory agencies impose internal audits and supplier audits in the pharmaceutical and medical device industries to ensure compliance with Good Manufacturing Practices and ISO standard requirements. These audits help identify potential problems that may affect product quality, efficacy or safety, and provide a mechanism for implementing corrective actions to minimize public health risks. In this blog post, we’ll discuss 7 key areas to focus on during internal or supplier audits.

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European Parliament adopts proposed amendment to MDR to extend transitional deadlines for certain Medical Devices 

The European Parliament adopts proposed amendment to Medical Devices Regulation 2017/745 (MDR) to extend transitional deadlines for legacy Medical Devices 

The European Parliament has approved a proposal to extend the transitional deadlines for certain medical devices under the MDR to ensure availability of devices whose certificates have expired or will expire before 26 May 2024. Manufacturers must adhere to specific conditions to comply with the new transition periods. Learn more here.

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