As part of the pharma industry, you’re well aware that data integrity and regulatory compliance are far more than tedious checklists. Ensuring your business meets the high ethical and security standards expected of you is absolutely critical for maintaining not just your reputation, but your very ability to operate. However, stringent requirements can pose considerable challenges that can be hard to overcome alone.
In this blog, we’ll provide a practical overview of how the IT infrastructure your business relies on can be tailored to support accurate, efficient data handling, and compliance with sector-specific GxP regulations.
Regulatory Trends and Their Impact on IT Infrastructure
Evolving GxP standards reflect a growing concern for safeguarding sensitive data and ensuring the reliability of systems that manage it. These trends demand that pharmaceutical companies continually assess and update their IT infrastructure to maintain compliance—it’s not enough to ‘set it and forget it’.
As regulations are updated, your businesses must ensure its IT systems are not only secure but also flexible enough to adapt to new requirements. This includes implementing advanced data management practices, maintaining comprehensive audit trails, and ensuring that all aspects of the infrastructure are aligned with current GxP standards.
In this landscape, staying ahead of regulatory trends is essential. Proactively aligning your IT infrastructure with GxP standards is key in mitigating risks, protecting data, and ultimately maintaining your competitive edge in a highly regulated industry.
Why Securing Your Data Starts from the Bottom Up
Most pharmaceutical businesses are adept at choosing and implementing software that adheres to compliance requirements. However, a blind spot often emerges when it comes to the very foundations of IT. Ensuring the protection of your regulated data is something that can (and should) be supported by every aspect of your IT environment, because just as a small crack can eventually cause a building to crumble, an overlooked weakness in one area could end up damaging your entire operation.
We’re not just speaking hypothetically—in 2017, Merck & Co. were hit by the NotPetya ransomware attack, which exploited vulnerabilities in their IT infrastructure. The attack severely impacted Merck’s operations, causing widespread disruption across their global network.
Despite having robust software controls, the attack shone a sobering light on the gaps in their network security and backup processes. The incident led to financial losses reaching $1.4 billion, which Merck’s insurers initially declined to cover, as well as operational disruptions, and challenges in ensuring data integrity and compliance.
The risks of a non-comprehensive approach to data integrity are real, and the price of non-compliance is simply too high to ignore.
How the Key Components of Your Infrastructure Can Support Data Integrity
Your IT infrastructure is the bedrock upon which all other layers of data security are built. It includes the technology that supports the processing, storage, and transmission of data. Each aspect of your infrastructure can be optimised to support a secure and GxP-compliant business.
Hardware
In terms of your servers, storage devices, and networking equipment, it’s important to implement:
- Robust access controls: Multi-Factor Authentication, complex passwords, role-based controls and more all ensure only authorised personnel can access the systems and data necessary for their role.
- Hardware encryption: Keeps data secure during transmission and storage, protecting it from loss, corruption, or unauthorised access.
- Performance monitoring: Frequent audits also help detect vulnerabilities and prevent them causing failures.
- Data backup solutions: Regularly verified and validated processes ensure data integrity and availability.
Software
When it comes to operating systems, databases, and applications, you should always use:
- Validated versions: Documented, industry-compliant software ensures that your systems are in alignment with compliance regulations.
- Regular patches: The latest updates address known vulnerabilities in software, keeping your data protected and your systems efficient.
- Comprehensive logs: Audit trails and electronic signature solutions help ensure traceability and maintain compliance.
Networks
Focus on the following measures for your local and wide area networks (LAN/WAN) and internet connectivity:
- Network segmentation: Minimises the potential attack surface for cyber-criminals, reducing the risk of data breaches.
- Intrusion detection systems: Alert your IT support team to any attempted cyber-attacks so they can be addressed before they impact operations.
- Secure configuration: Setting up your network with compliance in mind means you don’t leave any gaps in your data protection and compliance strategy.
Without a solid base, achieving compliance with regulations and ensuring the security of data assets is nearly impossible.
Why Outsource IT Infrastructure Management?
Trying to ensure that each aspect of your IT infrastructure adheres to the appropriate regulations whilst supporting your essential processes and keeping your data secure is no mean feat—let alone when you’re trying to run an entire department, or even the whole business, on top of it. An external IT support team could provide invaluable assistance here.
The core benefits of outsourcing your IT infrastructure management include:
- Expertise in Regulatory Compliance: An IT infrastructure support team that specialise in the pharmaceutical industry will be well-versed in GxP standards and other industry-specific regulatory requirements like 21 CFR Part 11. They can ensure that all your IT systems adhere to the appropriate standards, reducing the risk of non-compliance and the associated penalties.
- Ensured Data Integrity: Outsourcing allows your company to leverage advanced data management tools and protocols designed to protect data integrity, which ensures no part of your storage, processing, or handling are overlooked.
- Increased Peace of Mind: Constant monitoring from an experienced team means that in addition to seamless integration of new technologies or systems, you gain confidence that your IT infrastructure will continue to run efficiently and be maintained in a way that supports compliance.
- Focus on Core Competencies: By outsourcing IT management, you can focus more on your primary mission—research, development, and distribution of drugs—while leaving your IT infrastructure in the hands of experts. You’ll lose less time to compliance concerns, and gain the support of a partner that truly understands what your business needs.
By providing secure, compliant, and innovative IT solutions, tailored to pharma’s unique demands, outsourced IT support helps ensure operational efficiency and data integrity across your business.
Don’t Leave Data Integrity to Chance
Quite literally, pharmaceutical businesses cannot afford to compromise on the integrity of their regulated data. By knowing what you need to ensure data integrity and regulatory compliance across your entire IT infrastructure, you enable yourself and your team to concentrate on the opportunities ahead of you, rather than looking over your shoulder in anticipation of IT issues.
ITforPharma: Securing IT Regulatory Compliance and Regulated Data as Your Proven Technology Partner
As a specialised IT services partner to the pharmaceuticals sector, we’re an experienced and dedicated team serving businesses across the world. We understand the web of regulations facing pharmaceutical companies, and provide IT infrastructure support designed with compliance in mind. From fast, secure, and reliable technology to digital transformation solutions, we’re here to help you with all things IT.
Ready to ensure data integrity across your organisation? Book a meeting with our director James to enhance your IT infrastructure today.
