In our last blog, we discussed data integrity; essentially, the processes businesses undertake to ensure accuracy, consistency, and reliability of data. Give it a read if you missed out; we shared some valuable IT infrastructure advice to improve your data integrity practices overall.
Today, we’re exploring the integral policies and systems involved in ensuring not just the reliability of your data, but also adherence to the stringent compliance requirements pharmaceutical businesses are subject to.
The Importance of Clean Data
Human error, data entry mistakes, software or hardware issues, problems during data migration—any one of these factors could contribute to so-called ‘dirty’ data. Inaccuracies and inconsistencies can muddy the quality of information you’re using to make key decisions.
Especially when your business deals with large amounts of data, a lack of data integrity can affect product safety, efficacy, and quality. In turn, these go on to impact patient safety and public health, and ultimately, your reputation—especially if you’re in violation of compliance requirements.
The best way to avoid this? Ensuring data integrity remains a focus throughout your entire IT environment. Accurate, up-to-date records, which note any deviations or corrective actions, are paramount to being able to track your data and ensure it remains reliable the entire time it’s in your care. It’s just one part of the wider GxP requirements that IT services for pharmaceutical companies can help you meet.
Let’s examine some of the systems and processes you can integrate into your IT infrastructure to achieve this.
Audit Trails
A key aspect of accountability and auditing is having a detailed record of who’s accessed key data, when, and any changes they’ve made. An experienced support team will implement comprehensive audit trail systems to achieve this. They’ll capture and synchronise regulatory data logs, ensuring your data is fully traceable and reliable. This can look like:
- Capturing required regulatory data in infrastructure logs.
- Ensuring correct system time is synchronised across all devices (including Firewalls, switches, BMS, EMS, desktop, mobiles, temperate loggers) and accurately recorded.
- Retaining infrastructure logs.
- Ensure that EMS dependent infrastructure (like wireless networks) are monitored and available.
Confidentiality, Integrity and Availability
Aside from audit trails, there are several additional measures pharmaceutical companies can take to protect data from loss, corruption, or unauthorised access:
- Encryption of data at rest and in transit ensures it’s secure while being used or in storage.
- Backup integrity checking and backup test restores ensure data remains accurate and readily available.
- Disaster recovery and business continuity planning ensures that in the event of an emergency, your critical data can be quickly restored.
Electronic Records Management
In compliance with GxP requirements (like 21 CFR Part 11), electronic signatures must be unique to each individual and properly linked to their respective records. Whether you need to sign off on clinical trial information, NDAs, or change control documents, secure electronic records management systems ensure that these signatures are auditable and verifiable.
By implementing compliant digital signatures, a specialist IT team can help you maintain not just regulatory compliance, but the trustworthiness of your electronic documents.
System Validation and Documentation
To guarantee that your systems function as intended to stay aligned with compliance regulations, proper validation and documentation are essential.
An external service provider can conduct thorough validation processes including Installation Qualification (IQ), ensuring your systems are reliable and compliant with all necessary requirements. Proper documentation of this process also means that during regulatory audits, your business has clear evidence of compliance.
Security Measures
In addition to the above data integrity measures, it’s crucial not to overlook cyber security’s role in protecting your IT infrastructure, and all that it houses, from threats. Elevating your organisation’s security posture includes:
- Proactive patching of endpoints and network devices.
- 24/7 infrastructure monitoring with responsive helpdesk support.
- Secure configuration of network infrastructure and all network devices.
- Ensuring your staff are properly trained on cyber security best practices, and that you keep records of this training.
Each of these measures can be overseen by an experienced IT support team, helping you mitigate vulnerabilities and risks whilst ensuring you remain compliant with industry standards.
Tailor Your IT Infrastructure for Data Integrity, Compliance Auditing, and Beyond
By implementing robust data integrity practices and adhering to regulatory requirements, pharmaceutical companies like yours can safeguard patient welfare, maintain compliance, and sustain reputations—not just their own, but the wider pharmaceutical industry’s.
Ultimately, these measures support smoother compliance auditing, help maintain a sterling image, and protect against security issues like unauthorised access and data corruption. As the pharmaceutical industry continues to evolve, staying ahead with compliant, secure, and efficient IT infrastructure is essential for long-term success and trustworthiness in the eyes of regulators, patients, and the public.
ITforPharma: Providing Tailored IT Solutions for Pharmaceutical Companies and Startups
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? Speak to us about enhancing your IT infrastructure today.
