Compliance


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Data integrity (DI) for IT in the biopharmaceutical industry

Data integrity (DI) is an essential element in ensuring the reliability of data and information obtained and managed in biomanufacturing.  The number of observations made regarding the integrity of data during inspections of good manufacturing practice (GMP) has been increasing, clearly signalling a need for companies to better understand the requirements and ensure confidence in their compliance. In 2016, the BPIT compliance SMEs collaborated to co-author an industry response to the IT data integrity guidelines provided by regulators to support companies in understanding the requirements and in ensuring clarity in their approach to compliance. Furthermore, the guidance in the response paper and the companion template, “Universal Data Integrity System Assessment Template in the Biopharmaceutical Industry”, supports companies by providing a shared view of which controls to implement within a company and offers best practices to manage risks. This results in a common response to regulators and achieves increased confidence in a company’s approach to compliance. The guidance outlines the controls required generally and those required specifically for three categories of IT systems in biomanufacturing – enterprise applications, local systems and equipment.

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Data integrity (DI): Universal data integrity system assessment template in the biopharmaceutical industry

The subject matter experts of the BioPhorum IT Compliance Team developed this template in response to the need to ensure compliance with the regulatory guidance for data integrity demanded in the industry. The template was developed to assess the health of computerized systems and their electronic records from a data integrity perspective. Furthermore, it can be used to evaluate potential risks to a computerized system and its electronic records throughout the system’s lifecycle. An assessment may be conducted during requirements gathering as a part of the initial validation, during assessment of system changes, during periodic reviews and/or at the time of decommissioning. The assessment template should be fully developed in conjunction with a standard operating procedure (SOP) to manage consistent implementation and use. Since this is an example template it is not an exhaustive list of questions and should be augmented to meet each company’s specific needs. The template accompanies the “Data Integrity for IT in the Biopharmaceutical Industry” paper, which was developed in parallel to provide an industry response to regulatory guidelines highlighting risks, controls and best practices.

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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

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

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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