it governance, risk
and compliance
Translating the myriad of compliance and risk management requirements into tangible IT systems that comply with regulatory standards is a complex undertaking. Bridging the gap between high-level specifications and implementable solutions requires a great deal of understanding of both IT systems and regulatory compliance standards such as CFR 21 Part 11. We are familiar with IT standards defined by various regulatory bodies such as APRA, HEPPA, FDA, TGA, EHR, etc. Exigence is an expert in implementing GxP systems that are qualified, validated and production ready for any future audits. We will ensure that your mission critical systems are commissioned in accordance with the required standards and your change control and risk management practices.
essential eight
cybersecurity
Protecting your business from cyber threats is more important than ever. The Essential Eight is a set of baseline strategies designed to help organisations improve their cybersecurity posture. Developed by the Australian Cyber Security Centre (ACSC), these practical strategies are crucial for mitigating cyber risks and ensuring the integrity, availability, and confidentiality of your data. Cyber threats are constantly evolving, and even small vulnerabilities can be exploited by attackers. Biotech and pharma organisations are particularly vulnerable as they hold valuable intellectual property. Cybercriminals, including nation-state actors, target these assets for financial gain, industrial espionage, or to gain a competitive edge.
cloud solutions
The "Cloud" has disrupted the traditional concept of on-premise IT infrastructure. The notion of "cheap to start" and "cheap to trial" are some of the key benefits delivered by cloud solutions. Over the past five years, the delivery of cloud services has drastically matured. Exigence is an expert in hybrid cloud, where there is a balance of cloud and locally hosted solutions. An understanding of key cloud paradigms such as platform as a service, infrastructure as a service, and software as a service, ensures that we choose the right solution for your requirements. We ensure that your cloud services adhere to your risk management and regulatory compliance standards. Exigence has invested heavily in managed cloud services to ensure integration of disparate cloud services into a single, seamless, workable infrastructure. We abstract the technical aspects to deliver the services your business requires. The cloud has simply become another tool we use to solve your problems.