Compliance

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To err is human: How to improve risk management through ‘blue-sky’ human performance

To err is human: How to improve risk management through ‘blue-sky’ human performance

In any industry, quality is the building block of everything. People are relied on to deliver the services and products customers expect and need. This is especially so in biopharmaceuticals. But what happens when things go wrong? And what makes them go wrong in the first place? The reasons are myriad but ‘human error’ is often cited as the cause of problems such as accidents, product recalls and patient safety issues. Unfortunately, a human...

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New BPIT guidance to align cloud services to regulatory requirements

New BPIT guidance to align cloud services to regulatory requirements

Cloud services are being increasingly used to provide a cost effective and flexible platform for software. As GxP systems increasingly move onto the cloud agreement is vital for both provider and customer responsibilities to maintain compliance. For example, how does the provider ensure the security of the underlying infrastructure? Does the provider utilize commercially available software products that are developed and tested to IT industry...

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Data Integrity and Agile Webinars to support industry response to regulators

Data Integrity and Agile Webinars to support industry response to regulators

The BPIT Compliance workstream has published an industry response to the IT Data Integrity guidelines provided by regulators. An area that has been a major focus for inspectors in recent times. The guidance and supporting template provides clarity and agreement of the regulatory requirements, a shared view of which controls to implement within a company, and offers best practices. This results in a common response to regulators and achieves...

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BPIT provides clarity on data integrity

BPIT provides clarity on data integrity

The BPIT Compliance workstream has published an industry response to the IT Data Integrity guidelines provided by regulators. An area that has been a major focus for inspectors in recent times. The guidance and supporting template provides clarity and agreement of the regulatory requirements, a shared view of which controls to implement within a company, and offers best practices. This results in a common response to regulators and achieves...

read more