As companies move from traditional physical infrastructure operated in house to cloud computing, there are several important factors they must take into consideration. With this in mind, Scientific Computing has published a special series that examines the impact of good manufacturing practice regulations on cloud computing. It specifically looks at platform as a service (PaaS) and software as a service (SaaS) running on private clouds and at the importance of realizing that, although the operations are outsourced, the responsibility and accountability for GMP compliance remains with the regulated organization.
Part 1: The Applicable Regulations
Although the focus of this series is on GMP, the principles discussed are also applicable to Good Laboratory Practice (GLP) especially following the issue of the new draft guidance issued from the OECD in September 2014 and Good Clinical Practice (GCP) under which computerized systems are inspected in Europe by using a PIC/S Guidance on Computerised Systems in GXP Environments written by GMP inspectors. Many GMP-regulated companies are considering using the cloud to reduce cost and outsource applications. The financial benefit is to move from a capital to a revenue cost model. However, have the people involved in the process considered the impact of GMP regulations on their choice of cloud supplier?
Read Part 1: www.ScientificComputing.com/Cloud_Meets_GMP_Regulations_1
Part 2: SaaS and Qualified IT Infrastructure
In this part, we look at the SaaS hosting options available to consider for regulated users and the requirement for qualified IT infrastructure. The great advantage of SaaS from the perspective of the company is that the potential financial cost model moves from a capital cost one (purchase of the software and associated licenses) to a revenue cost one (hire of user accounts and the software). However, we need to go into more detail about how SaaS can be delivered, and we have two main options to consider.
Read Part 2: www.ScientificComputing.com/Cloud_Meets_GMP_Regulations_2
Part 3: Options for Auditing a Cloud Service Provider
In this part, we will look at the ways you can audit a cloud service provider. Annex 11 provides some guidance…
Read Part 3: www.ScientificComputing.com/Cloud_Meets_GMP_Regulations_3
Part 4: Selecting a Cloud Service Provider
In this part, we look at a process to select a suitable hosting provider that can demonstrate compliance with GMP and possess qualified IT infrastructure. The process consists of three stages.
Read Part 4: www.ScientificComputing.com/Cloud_Meets_GMP_Regulations_4
We welcome your comments and input on these topics. Please send your feedback to [email protected] or post your comments directly at the end of each segment.
