The pharmaceutical, biopharmaceutical, and medical device industries have grown increasingly global in nature, a trend that will only continue. How companies sell their products around the world and share information with both internal and external customers and suppliers has become quite complex, often depending on supply chains that traverse multiple international boundaries. As such, companies are increasingly reliant on computer systems that must support users in locations around the world. Global information systems can span the entire range of a companies’ business operations, including such GxP-relevant classes of applications such as:
- Manufacturing Execution Systems (MES)
- Enterprise Resource Planning (ERP) Systems
- Electronic Document Management Systems (EDMS)
- Laboratory Information Management Systems (LIMS)
- Chromatography Data Systems (CDS)
- Clinical Data Management Systems
- Pharmacovigilance Systems
- And many others
The challenges associated with such systems are myriad, including:
- Selecting the global application, to include choosing the best architecture for the system
- Implementing the system, including:
- Assigning system ownership
- Consideration of optimal project team structure
- Cultural issues
- Project phasing, including pilot strategies
- Validation of global applications using the GAMP® 5 methodology
- Managing a global system, including achieving consistently good service levels across all sites and maintaining the validated state
- Managing the complex relationship with suppliers in a global context
- Ensuring data integrity in the global system, including compliance with various national healthcare authorities’ regulations and meeting related local laws, e.g. those governing data privacy
The GAMP® Good Practice Guide Global Information Systems Control and Compliance offers useful discussion of all of the above issues, and following this guidance will significantly aid project managers, business process owners, validation team members, IT support staff, data stewards, and anyone else involved in developing, using, or supporting global information systems.
This second edition of the Guide looks at global computer systems through the lens of the latest approaches to Quality Risk Management, and discusses modern technologies and system architectures including the use of cloud computing, up to the ultimate cloud solution, Software as a Service (SaaS). It addresses one of the principle current regulatory concerns, data integrity, in the context of data managed and/or handled in multiple nations.
Anyone in an executive, management, project, or operational role involving a global GxP system will benefit from utilizing the GAMP® Good Practice Guide Global Information Systems Control and Compliance.
By: Randy Perez, PhD
Learn more about the GAMP® Good Practice Guide Global Information Systems Control and Compliance and how to purchase it today!
Contributors to the ISPE GAMP® Good Practice Guide: Global Information Systems Control and Compliance include:
- Winnie Cappucci, Bayer Healthcare (retired), USA
- Chris Clark, TenTenTen Consulting, United Kingdom
- Gail Evans, Technical Writer/Editor, United Kingdom
- Colin Jones, Conformity Limited, United Kingdom
- Randy Perez (Lead), Novartis (retired), USA
- David Stokes, Convalido Consulting Limited, United Kingdom
- Lorrie Vuolo-Schuessler, GlaxoSmithKline, USA
- Christopher White, Alexion Pharmaceuticals, USA
- Sion Wyn, Conformity Limited, United Kingdom
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