It is a critical consideration as processes and data transition into the digital realm, where the risk of cybercrime escalates. Consequently, it is imperative to integrate a cybersecurity strategy into the digital value chain. IT infrastructure qualification plays a pivotal role in documenting the measures and risk mitigations related to cybersecurity.
Regulatory Compliance
IT infrastructure qualification is essential to comply with regulatory guidelines, such as those set forth by the FDA (Food and Drug Administration) in the United States or the EMA (European Medicines Agency) in Europe. These regulations require companies to ensure that their IT systems do not compromise the safety, efficacy, or quality of products.
Risk Assessment
The qualification process involves assessing and mitigating risks associated with the IT infrastructure. This includes identifying potential vulnerabilities, data security risks, and system failures that could impact product quality or patient safety.
Change Control
It is expected that companies have robust change control processes in place to manage any modifications or upgrades to the IT infrastructure. Changes should be documented and assessed for impact on qualification status.
User Access Control
Ensuring that only authorized personnel have access to critical systems and data is crucial. IT infrastructure qualification includes measures to control user access, monitor activities, and maintain data integrity.
Data Integrity
Data generated and stored by IT systems must be accurate, complete, and secure. Qualification ensures data integrity by implementing controls and safeguards against data corruption or manipulation.
Periodic Review
IT infrastructure qualification is not a one-time process; it requires periodic review or requalification to ensure that the infrastructure remains in compliance with evolving regulations and industry standards.
Audits and Inspections
Regulatory agencies may conduct audits and inspections to verify IT infrastructure qualification and compliance with relevant regulations. Proper qualification documentation is essential to demonstrate compliance during such reviews.
Training and Documentation
Personnel involved in managing and operating IT systems should receive adequate training, and their activities should be well-documented to ensure accountability.

Overall, IT infrastructure qualification is a critical component of ensuring the integrity, security, and compliance of information technology systems in regulated industries.

It plays a vital role in maintaining product quality, patient safety, and regulatory adherence throughout the product lifecycle.

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Here are key aspects and considerations of OT infrastructure qualification:

Regulatory Compliance
In industries where safety, reliability, and compliance are critical, such as energy, utilities, and manufacturing, OT infrastructure qualification is essential to meet regulatory requirements and standards. Compliance with industry-specific regulations is necessary to ensure the safe and reliable operation of industrial processes.
Risk Assessment
Like IT infrastructure qualification, OT infrastructure qualification involves assessing and mitigating risks associated with the OT environment. Identifying potential vulnerabilities, security risks, and system failures is crucial to maintaining the safety and integrity of industrial processes.
Change Control
Effective change control processes are essential for managing modifications, upgrades, and patches to the OT infrastructure.
Security Measures
OT infrastructure qualification includes security measures to protect industrial control systems from cyber threats. These measures often align with industry-specific cybersecurity standards and guidelines.
Redundancy and Failover
Qualification may involve testing redundancy and failover mechanisms in the OT infrastructure to ensure that critical industrial processes continue to operate even in the event of hardware or software failures.
Compliance with Industry Standards
Different industries may have specific standards and guidelines for OT infrastructure qualification. These standards, such as those published by organizations like ISA™ (International Society of Automation), provide best practices for ensuring the reliability and safety of industrial processes.

Overall, OT infrastructure qualification is vital for industries that rely on industrial control systems to maintain the safe and efficient operation of critical processes.

It helps ensure compliance, safety, and reliability in the OT environment, reducing the risk of disruptions and incidents that could impact production and safety.

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Here are key aspects and considerations of OT infrastructure qualification:

Qualifying infrastructure
Serves as a preventive measure against potential fines, product recalls, and legal complications. Additionally, it plays a pivotal role in ensuring a company's compliance with standards such as ISO 27001 (Information Security Management) and SOX (Sarbanes-Oxley Act), further fortifying its operational and regulatory posture.
Cost Reduction
Qualifying infrastructure can yield operational efficiencies, minimize downtime, and decrease maintenance expenses, culminating in long-term cost savings. Moreover, when a standardized infrastructure is utilized across multiple systems, tasks remain efficient, eliminating the need for redundant installation qualification tests for each system requiring validation within the same IT or OT infrastructure.
Competitive Advantage
Companies with a reputation for high-quality products and compliance are more likely to gain a competitive edge and attract customers, partners, and investors.

Scope of Infrastructure Qualification

The figure below illustrates the extent of infrastructure considerations and highlights the necessity of including certain IT-related business processes within the purview of qualified infrastructure.

Infrastructure Qualification versus Application Validation

A regulated company adopts a structured approach when implementing an application to fulfill its business requirements. This involves defining requirements, configuring the application as needed, conducting risk-based verification, establishing operational controls, and maintaining it in a controlled state – collectively known as validation.

However, this process is generally more straightforward for most application elements compared to infrastructure elements. The company typically has no direct influence on the design and manufacturing of components like servers, network switches, etc., which are essentially off-the-shelf purchases. After confirming the acceptability of the initial component build, new components are usually configured to a standard, and the testing of each build may be minimal (e.g., confirming network connectivity between nodes) or even non-existent (e.g., relying on a review-by-exception approach). Certain components may undergo initial verification but might also require additional configuration and subsequent verification of that configuration. Infrastructure, which continuously evolves to meet evolving business needs, should be systematically managed to maintain a controlled state. Both confirming the fitness of components for their intended purpose and managing them to remain controlled often involve automated processes. The dynamic nature of infrastructure, coupled with the widespread use of standardized components following the "one qualification, many implementations" model, represents the primary distinction emphasized in EU Annex 11. It's important to note that infrastructure software typically falls under GAMP® category 1, meaning it is qualified rather than validated. This distinction recognizes the unique characteristics of infrastructure components and their management within regulated environments.

IT Processes in Scope for Infrastructure Qualification

Many IT-managed processes play a crucial role in maintaining the controlled state of applications. Various resources, such as ITIL, offer excellent frameworks for managing these IT business processes. Some of these processes necessitate input from business application users. For instance, business input is essential for defining expected service levels, including help desk hours, response times, and other related factors.


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