Andreas Eschbach, CEO and Founder
Cloud-based plant process management (PPM) software can help pharmaceutical and chemical companies improve system reliability and data security. Here's what manufacturers should look for in a secure cloud-based PPM solution.
Moving to cloud-based applications for plant process management, shift handover and other plant operations offers significant benefits for pharmaceutical manufacturers—such as anywhere/anytime access to critical data, streamlined operations, and a lower IT burden for server and software management. But what about data security?
While keeping data close at hand on an enterprise network may feel like a safer option, a well-designed cloud-based application can offer significant advantages in terms of data security. Moving to a cloud-based plant process management system that complies with modern security standards and regulations can be an important part of a data security plan for pharmaceutical manufacturers. When choosing a service provider, it is important to ensure that the application has been designed with best practices in cloud security, including infrastructure design, software development methods, disaster recovery planning, security monitoring, and incident response.
Plant process management systems and other networked applications contain a wealth of valuable data, making them a tempting target for hackers and data thieves. Manufacturers in 24/7 process industries such as pharmaceuticals also have unique vulnerabilities to operational disruption from cyberattacks such as ransomware attacks or software supply chain attacks. A data breach or data loss can put pharmaceutical plants at significant risk. Some of these risks include:
For all these reasons, data security is an essential consideration for PPM software. There are three important aspects of data security to consider. Is the data protected from unauthorized access? Is the data accurate and complete? And is the data available when and where you need it? These three pillars of data security—confidentiality, integrity and availability—are commonly referred to as the CIA triad.
To protect companies from business disruptions and losses, the PPM solution must be designed to address all three elements of the CIA triad.
Many organizations believe that keeping data on their own network is safer than trusting it to a cloud-based service provider. After all, you know exactly where your data is and how it is stored. However, storing data on your own network may not be as secure as you think. Locally hosted data and applications exist within a complex IT ecosystem that provides plenty of opportunities for data theft, loss or tampering. Here's why.
Cloud software can provide an added level of security through the browser by offloading much of the work and risk associated with running and updating software to the cloud service provider (CSP). When using cloud software through a browser, the user is accessing the software that is running on the CSP's infrastructure rather than on their own network. This can provide several security benefits.
A Software-as-a-Service (SaaS) model allows manufacturers to leverage the security capabilities of the CSP, reducing the burden on the pharmaceutical company to manage and secure their own software and providing a more centralized and secure approach to software management.
Cloud security encompasses a number of best practices designed to ensure data confidentiality, integrity and availability. These include system architecture, software development practices, backup and disaster recovery planning, security monitoring, testing and analysis, and incident management.
Secure cloud architecture includes a combination of best practices, policies and technologies that work together to protect data, applications and infrastructure in a cloud computing environment. Important elements of secure design for cloud applications include:
Software Development Practices
Secure software development integrates cybersecurity at every stage of development and operations—a practice known as "DevSecOps." Cloud services for sensitive and mission-critical software used by the pharmaceutical industry should be developed using a DevSecOps approach. This includes:
Backup and Disaster Recovery
Backup and disaster recovery planning is one of the keys to data availability and integrity. Where are servers physically located? How (and how often) is client data backed up? How is the application itself backed up? What is the recovery plan in the case that servers are physically destroyed or otherwise unavailable—for example, due to a natural disaster at the data center? Geo-redundant servers and database backups, in which data and applications are stored in more than one geographic location, significantly decrease the risk of catastrophic data loss. It is also important to have a backup schedule appropriate for the business and the type of data being stored. The CSP should have a fully documented backup and disaster recovery plan that outlines backup frequency, primary and backup server locations, automated recovery methods, security measures for backups, and recovery time objectives.
Security monitoring for cloud-based PPM solutions should be ongoing, comprehensive and multi-layered. A security monitoring program includes both external and internal monitoring.
Testing and Analysis
Regular testing and analysis of the infrastructure and hosted application are crucial. This typically includes external black-box and gray-box penetration testing and threat modeling for both the software and the infrastructure, as well as internal analysis to detect signs of current or past attacks. These tests are used to discover previously unidentified vulnerabilities and inform development of software patches or other mitigations to harden the system.
CSPs also must have an incident management and response plan in the event that a problem that impacts data confidentiality, integrity or availability is discovered. This includes procedures for detection, communication, mitigation and forensic analysis of security events.
When selecting a SaaS provider,
pharmaceutical manufacturers should ensure that the application has been
developed in accordance with industry best practices and standards for
cybersecurity. ISO 27001 is an international standard for information
security management that provides a framework for establishing, implementing,
maintaining and continually improving security management systems, procedures
and policies. When evaluating PPM software for security, an ISO 27001
certification is a good place to start. This certification indicates that the
provider has undergone a thorough audit and assessment by an independent
certification body and shown that they are compliant with the standard. You can
also look for an ISO 9001 certification, which indicates that their
quality management systems are compliant.
In the U.S., you may also want to ask for a SOC 2 report. SOC 2 is a type of audit and report that provides assurance on the effectiveness of a service organization's controls related to security, availability, processing integrity, confidentiality and privacy.
When shifting process management to the cloud, security is essential. By implementing the right security measures, a cloud-based PPM system can provide the level of security and reliability that pharmaceutical companies need to effectively manage their processes and protect sensitive data.