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Optimising cloud provisioning for pharmaceutical compliance and operational excellence

Suresh Perikala, Senior Engineering Lead – DevOps and Cloud Engineering Practice, Altimetrik explains how the industry can obtain solutions that help ensure compliance and enable operational excellence

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In the last few years, we have witnessed the pharmaceutical industry in its most intense form. With the onset of the COVID-19 pandemic, they have spared no effort in providing crucial vaccinations to protect the world. Today, they are utilising advanced technologies to speed up the creation of therapies and treatments to eliminate life-threatening diseases.

However, executing this is easier said than done. The pharmaceutical industry operates within an elaborate regulatory environment that often demands a delicate balance between innovation and compliance. Adhering to stringent compliance with regulatory standards – such as GxP (Good Practice), Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), and Good Clinical Practice (GCP) – helps to ensure the safety, quality and efficacy of the products. The industry demands solutions that help both ensure compliance and enable operational excellence.

Challenges in Pharmaceutical cloud infrastructure

Playing within a stringent regulatory landscape, pharmaceutical companies often come across significant hurdles in managing their cloud infrastructure. With extremely sensitive patient data in their hands, ensuring data security and privacy is non-negotiable. This demands strong encryption with strict access controls. Moreover, since pharmaceutical operations often involve crosstalk between diverse systems across global operations, integrating these systems adds to the complexity while demanding seamless interoperability and performance. With cloud provisioning, pharmaceutical operations can enable flexibility, scalability, and cost efficiency while ensuring compliance with industry standards.

Importance of Data Security, Privacy and Governance 

Data security, privacy, and governance are crucial pillars in the pharmaceutical domain due to the sensitive nature of patient data and proprietary research. These call for robust security measures such as encryption and access controls, to safeguard against breaches and unauthorised access. Additionally, effective governance frameworks align data management practices with regulatory requirements, limiting risks and fortifying stakeholder trust.

Infrastructure as Code (IaC) and Automation

Infrastructure such as Code (IaC) and automation have been ground-breaking for cloud provisioning in the pharmaceutical industry. With IaC, companies can manage and allocate cloud resources via code. This allows for consistency, repeatability, and reduced manual errors. On the other hand, automation streamlines processes, considerably limiting the time and effort required for infrastructure management.

Ultimately, IaC and automation are a tag team that helps improve operational efficiency and scalability and ensures a compliant and secure cloud ecosystem that supports faster innovation and effective resource management.

Ensuring compliance through automated processes

Compliance checks are as common as they get in the pharmaceutical sector’s workflow. Automating these processes can be critical in helping pharmaceutical companies manage their cloud infrastructure. They can help limit the risk of human errors while also ensuring consistent adherence to regulatory requirements like GxP standards.

Automation can help in various ways—it can help monitor and enforce security policies, conduct timely audits, andeven generate comprehensive reports for regulatory bodies. With the automation of compliance processes, pharmaceutical companies can experience an enhancement in their efficiency and reduced operational costs, all while maintaining a robust and secure cloud environment that is in line with all regulatory mandates.

Business outcomes of optimised cloud provisioning 

With cloud provisioning in the pharmaceutical sector optimised, companies can experience a considerable uptick in business outcomes. Here are some illustrative examples on how it can pan out. 

Establishment of self-service capabilities: A leading pharmaceutical company implemented a self-service portal for its research and development teams. This allowed scientists to provision virtual machines and storage on-demand, reducing the average provisioning time from several days to just a few hours. As a result, researchers could quickly access the computing resources needed for data analysis, leading to faster drug discovery timelines. 

Increased efficiency through automation: A global pharmaceutical firm automated its cloud infrastructure provisioning using Infrastructure as Code (IaC) tools. The company reduced manual provisioning efforts by 70 per cent by scripting the deployment process, allowing IT staff to focus on strategic projects rather than routine tasks. This automation also led to a 30 per cent decrease in infrastructure-related errors, enhancing overall operational reliability.

Creation of launch constraint roles and policies: A biotech startup established a set of launch constraint roles and policies within its cloud environment to manage access to sensitive data and applications. The company ensured only authorised personnel could deploy new applications by implementing role-based access control (RBAC) and automated compliance checks. This approach secured sensitive patient data and streamlined the approval process for new application launches, reducing the time-to-market for new therapies.

Implementation of code management practices: A pharmaceutical organisation adopted GitOps practices for managing its cloud infrastructure configurations. By using version control for infrastructure code, the company achieved greater scalability and reusability of configurations. This allowed teams to replicate successful setups across multiple projects, reducing deployment times by 50 per cent and enabling quicker responses to changing regulatory requirements.

The future of cloud provisioning in the pharmaceutical industry 

The optimisation of cloud provisioning will continue to be a critical strategy for pharmaceutical companies that are striving for compliance and operational excellence. As regulations become more stringent and complex, adopting newer technologies such as IaC and automation will become the norm. 

The potential benefits that it brings – in the form of compliance, efficiency, and cost savings – make it a worthwhile investment, despite the challenges along the way, all while driving business growth. Together, pharmaceutical companies can ensure they are well-positioned to meet the demands of the future.

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