360° Data Integrity
Achieving comprehensive Data Integrity within Pharmaceutical and BioTech organisations requires addressing the entirety of your IT infrastructure, not just isolated components.
Compliance goes beyond your line of business applications; your IT in its entirety needs to adopt these six pillars of true best practice Data Integrity.
Protecting regulated data extends beyond specialized systems like LIMS; it necessitates comprehensive coverage across six key pillars of your whole IT infrastructure – wherever you store, collaborate, or communicate with data of all kinds.
Are all these pillars in place to safeguard the adoption of best practice in your organisation?
1. Access Control and User Authentication
Need to know basis
2. Audit Trails
Ensuring Reliable and Secure Data Processing
3. Data Confidentiality, Integrity, and Availability
Secure, Available, Accurate
4. Electronic Records Management
Keep Data Reliable From Start to Finish
5. System Validation & Documentation
Don't Give Risk A Chance
6. Security Measures
Shielding Your Compliance and Continuity
What practical steps do I need to employ to achieve comprehensive Data Integrity?
Access Control and User Authentication
- Multi-Factor Authentication (MFA)
- Role-based Access Control
- Unique User IDs
- Robust Access Control SOPs
- Complex Passwords
- Regular Enforced Password Changes
Audit Trails
- Capturing Regulatory Data
- Synchronisation of System Time
- Retaining Infrastructure Logs
- Monitoring EMS-Dependent Infrastructure
Confidentiality, Integrity, and Availability
- Backup Integrity Checking
- Backup Test Restores
- Encryption of Data at Rest and in Transit
- Disaster Recovery and Continuity Planning
Electronic Records Management
- Highly secure ERM systems
- Consistent Data Integrity measures
- 21 CFR Part 11 Compliant Digital Signatures
- Ensure that electronic records are verifiable
System Validation and Documentation
- System Validation and IQ
- Document Validation and IQ
Data Security Measures
- Security Patching
- 24/7 Advanced Monitoring
- Secure Configurations
- Cyber Security Training
"ITforPharma have helped ensure that Crescent Pharma operate to the highest data security standards and MHRA Data Integrity requirements are being maintained.”
How ITforPharma helps you achieve Data Integrity.
ITforPharma offers comprehensive IT services to ensure Data Integrity and regulatory compliance across your entire IT infrastructure. Our services include proactive IT support, robust cybersecurity, scalable cloud solutions, and effective data management practices based on industry best practices. Additionally, we provide digital transformation and VoIP telephony solutions to enhance operational efficiency.
These integrated services create a framework that maintains data confidentiality, integrity, and availability, ensuring seamless GxP adoption to support the critical needs of the pharmaceutical industry.
IT & Data Management &
Virtual Chief Information Officer (vCIO)
For pharmaceutical companies seeking leadership and alignment between IT and GxP requirements, our IT & Data Management and Virtual Chief Information Officer (vCIO) service offers strategic oversight and expert guidance. We ensure your IT infrastructure supports regulatory compliance, enhances Data Integrity, and meets operational goals. Our vCIO service provides tailored recommendations, optimises technology investments, and manages risk. By partnering with us, you receive dedicated IT leadership that understands the complexities of the pharmaceutical industry, ensuring seamless integration of technology and compliance requirements.
- Expert team with knowledge specialising in both IT and pharma.
- Gain a dedicated virtual CIO to align IT strategy with GxP requirements.
- Benefit from improved IT infrastructure management and risk mitigation.
IT Support
Pharmaceutical companies require reliable IT infrastructure to ensure compliance and business continuity. Our IT support ensures systems remain optimised and compliant, offering 24/7 monitoring, proactive maintenance, and a responsive helpdesk for your team. We’ll firstly understand your business and IT needs, assessing your environment for improvements. We ensure a smooth transition to better IT, we’ll take care of your technology, while you take care of your business. When issues arise, it won’t be long until you reach a friendly voice.
- A friendly and proactive team who know and speak IT and pharma.
- Improve uptime, performance, and reliability with proactive IT support.
- Get a fast and friendly response when IT issues arise.
Cloud Solutions
To manage data and facilitate collaboration, pharmaceutical companies need scalable, GxP-compliant cloud services. Our solutions provide secure, flexible operations and enhanced collaboration, ensuring Data Integrity with Microsoft 365 and Azure, supported by proactive compliance documentation. Cloud solutions enable smarter work, scalable IT systems, and use of the best-in-class cyber security solutions, ensuring robust security and compliance across your cloud environment.
- Deploy GxP-compliant cloud environments that ensure Data Integrity.
- Unlock flexibility, scalability, and enhanced productivity.
- Improve collaboration through secure real-time document editing, live file sharing, and by integrating tools and data closer together.
Cyber Security
Pharma organisations require robust protection against cyber threats to safeguard data and ensure compliance. Our cyber security solutions enhance your security posture by preventing data breaches, protecting reputational impact, and maintaining compliance. We achieve this through the implementation of robust, yet practical technical controls; combined with advanced threat detection and response systems, alongside active security auditing, to both instil and sustain an ongoing best practice level of security & privacy.
- Ensure data security and meet international standards.
- Shield your business from common and sophisticated threats.
- Enhance business resiliency and be ready for the unexpected.
Digital Transformation
Pharmaceutical businesses need to modernise their IT to stay competitive. Our digital transformation services enhance operational efficiency, streamline workflows, and ensure compliance with evolving regulations. We implement new technologies that improve workflows and decision-making, enabling your business to work both better and faster.
This includes integrating IT systems, enabling secure remote work, automating processes, and upgrading phone systems for example. We approach digital transformation thoughtfully and tailored to help you achieve your ambitious goals while ensuring a smooth, secure process.
- Harness profitable IT solutions to achieve your commerical goals.
- Realise your IT strategy milestones on-time, and in-budget.
- Ensure best-in-class security in your IT environment and IT projects.
A mapped-out path towards Data Integrity for your business.
Find out how our proven processes can help you to accurately meet Data Integrity standards across your IT environment.
- Tailored for Pharma: Gain insights from experts who understand both pharma and IT, ensuring your specific needs are addressed.
- Eliminate Risks: Receive a comprehensive gap analysis of your IT environment with actionable steps to mitigate risks.
- Meet GxP Standards: Learn how to meet GxP standards from FDA, MHRA, and EMA with a clear, practical roadmap.
- Audit For Just £695: Get a tailored consultation and audit for only £695, providing a detailed plan to secure your data and ensure compliance.
To achieve comprehensive Data Integrity, focus on your entire IT infrastructure, not just line-of-business applications and databases. This holistic approach includes secure authentication, robust cyber security, reliable backups, and stringent data management practices.
Ensuring these elements are in place supports the confidentiality, integrity, and availability of all regulated data. Such measures are essential for compliance with GxP standards, providing a secure and reliable foundation for your business operations.