The ISPE GAMP® Blockchain Special Interest Group is excited to be in its 4th year! For those of you following this space I’m sure you can appreciate the roller coaster of events across crypto, blockchain, and pharma over that time. Yet despite many of the external challenges the core technology behind blockchains has remained secure, available, and immutable – just as they were...
This article aims to refresh information on open-source software (OSS) within regulated computerized systems that was first discussed in an article in May-June 2010 Pharmaceutical Engineering®. The adoption of OSS advanced since then, and the article explores the importance of recognizing when an organization is relying on OSS and the benefits and risks this brings from a GAMP® 5...
This article introduces the concept of robotic process automation (RPA) and discusses how the technology may be used within a GAMP® framework to support both non-GxP and GxP processes.
To facilitate the assessment and mitigation of compliance risks associated with a third-party service organization, its services, and the systems used to provide the services, this article proposes adopting an approach from the financial sector that, with a little modification, could be used to assess suppliers of GxP-regulated IT services.
This article discusses how blockchain technology may disrupt the way we collect and manage data within regulated processes. The first section is a nontechnical summary of blockchain’s features, including a description of what it is (and what it is not). This sets the context for the next section, in which we discuss several blockchain use cases currently being piloted by life sciences...
Fifteen years ago, corporations embarked on a journey toward SOX compliance; along the way they have learned a tremendous amount about data integrity as it relates to financial systems. Those lessons learned are directly applicable to many of the data-integrity challenges facing the pharmaceutical industry today.
