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Embracing Infrastructure as Code (IaC) for Better Efficiency, Security, and Compliance

The pharmaceutical industry has often faced criticism for its slow adoption of cutting-edge technologies. However, a positive shift is underway as the sector begins to recognise the importance of staying on top of technological advancements. As mentioned by the ISPE (International Society for Pharmaceutical Engineering) in the article titled, ‘The Use of IaC in Regulated Companies’, the most significant leap forward is the increasing adoption of Infrastructure as Code (IaC).

Anders Vidstrup, the author, states that IaC is a means of provisioning and deploying infrastructure using development/operations processes, enhancing quality as it relates to compliance and operational stability.

The most significant leap forward is the increasing adoption of Infrastructure as Code

The successful adoption of IaC can be attributed to the myriad opportunities it brings to the realm of software development and IT operations. Pivotal aspects such as version control and audit trails enable teams to efficiently manage and track changes to their infrastructure’s codebase.

1. Version Control

IaC allows for the systematic and versioned management of infrastructure changes, akin to version control systems. This ensures traceability, reversibility and collaborative development as each modification can be easily traced back to the individual responsible, the timestamp of the change and the rationale behind it. Developers can also work concurrently on different aspects of the infrastructure, fostering a systematic and organised approach to configuration management.

2. Automated Checks

Automation in IaC streamlines deployment and configuration processes, introducing consistency and reducing the risk of human error. Automated checks validate configurations against predefined criteria, enhancing the reliability and security of the infrastructure. This is particularly critical in an industry where precision and accuracy are paramount.

3. Audit Trails

Integration of audit trails provides transparent records of changes, including details such as who made the changes, when they were made and the reasons behind them. This fosters accountability and facilitates continuous improvement within development and operations teams. It aligns with the pharmaceutical industry’s need for meticulous documentation and compliance.

4. Alignment with GAMP

The adoption of IaC seamlessly aligns with Good Automated Manufacturing Practice (GAMP) standards, particularly applicable within GAMP category one.

  • It incorporates principles from GAMP 5, the latest version of the GAMP standards.
  • It emphasises crucial aspects such as risk management, software categorisation and a lifecycle approach to validation.
  • Focuses importance on robust documentation, ensuring transparency in the technology integration process.
  • Highlights the significance of user involvement and collaboration throughout the development and validation phases.
  • It reinforces the industry’s commitment to maintaining high standards in technology integration.

Infrastructure as Code at OneSC

Onesc’s cloud platform utilises Infrastructure as Code (IaC) to provide scalable infrastructure resources. This enables the dynamic adjustment of resources to meet changing demands in the pharmaceutical industry. Here is how IAC has helped us:

1. Efficiency and Streamlined Operations

The implementation of IaC ensures streamlined and efficient pharmaceutical processes. Automation and systematic management contribute to a more reliable and responsive technological infrastructure, eliminating unnecessary complexities.

OneSC has integrated workflow automation, the system takes into account the user’s business priorities and schedules, generating a meticulously organised task list automatically. This empowers users to concentrate on the most pertinent tasks, ultimately enhancing productivity and ensuring timely review and release of batches to the market.

The system also brings efficiency to the forefront, enabling rapid and resilient creation of environments and infrastructure replicas. This efficiency allows engineering teams to focus on product development with confidence in quick infrastructure establishment.

2. Enhanced Security Measures

By integrating IaC, the platform strengthens security protocols, reducing vulnerabilities and ensuring the integrity of pharmaceutical operations. Automated checks and version control contribute to a robust security framework, minimizing risks.

OneSC further enhances security through the implementation of Single Sign-On (SSO), simplifying user authentication processes and promoting seamless access to the platform. This approach not only fortifies user access control but also streamlines the user experience. There is also user-specific permissions. which tailors platform access based on individual roles and responsibilities, ensuring that each user has precisely the permissions required for their designated tasks.

3. Improved Accountability

As IaC is in line with GAMP standards, it enhances accountability in technology integration. Principles from GAMP 5, including risk management and lifecycle validation, strictly reinforce accountability as it not only streamlines the deployment of IT infrastructure but also provides a clear and auditable trail of changes made throughout the system’s lifecycle.

OneSC takes this one step further by providing unparalleled traceability for each batch, enabling users instant visibility into its current production stage. Users can also effortlessly view, assign and upload documents, as each document revision is systematically recorded and tracked it allows users to easily compare different versions and identify changes.

The platform effectively combines IaC and GAMP principles to establish a foundation for a more resilient, traceable and compliant technological framework within the pharmaceutical sector. Please get in touch if you want to discuss how IAC can help you!

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