Pharmaceutical and medical devices companies may take more time to adopt cloud-based software applications, such as ERP systems, than the average non-regulated company. The technology and related service models challenge what this type of companies grown accustomed to in terms of internal policies/procedures, and compliance with Good Manufacturing Practices (GMPs) requirements enforced by regulators.
The Life Sciences industry is quite risk averse for obvious reasons. Therefore they embrace technology that impacts their regulated processes only once proven in terms of its ability to be brought in compliance with Part 11 or Annex 11, and maintained as such.
Cloud and Data Integrity
Imagine the situation of using a cloud-based ERP system in a regulated manufacturing environment. A lot of data is generated, like production records, batch records, and other quality records. These become external to the manufacturing site. This potentially impacts the company’s ability to make copies of records in human and machine readable format, archive their data records if required, or restore those records in case of an error or incident. From a regulatory perspective, this introduces data integrity risks and would have major impact on compliance with for instance FDA’s 21 CFR Part 211 (cGMP for Finished Pharmaceuticals).
Next to regulatory challenges, there are specific features of cloud solutions that introduce serious challenges for the Life Science industry. Automated software version upgrades are a good example, as they can be pushed often without the option of opting-out. Applauded by the average user organization, but triggering alarm bells from a GMP point of view, as this will require the regulated company to set change processes in motion that include risk and impact assessments, functionalities that need to be (re)tested and approved by multiple departments, and so on.
These are just two of many aspects that need to be assessed when considering a cloud ERP solution that covers GMP-critical processes. In our Expert Paper we will elaborate on the following topics:
1. Explain different Cloud Models
2. Real-Life Examples of Software as a Service (SaaS) ERP
3. What the Regulators think about Cloud
4. The role of Cloud Service Providers (CSPs)
5. Determine the readiness of the CSP for serving the Life Sciences industry
6. Formal agreements with your CSP
7. Validation of SaaS ERP
8. Challenges after Go-Live