Digital Compliance and Protection for the Life Sciences Industry
New requirements and new technology create new challenges in Life Science
The Life Science industry is constantly changing, with new technologies and new requirements arising on a daily basis. To meet these challenges, GxP-CC offers life science digital compliance services with validation practices that ensure your systems are in line with GxP regulatory requirements and can handle any data protection or security challenges they may face. We help you create a robust system validation program for this new digital compliance scenario by providing tools and services that enable you to:
- Manage risk and assure compliance with regulations
- Reduce development costs by providing agile validated approaches
- Increase quality through innovative and lean process validation
Our team of experts will work with you to identify your needs and implement solutions that allow you to achieve your goals. With our services, we’ll not only make sure your systems are compliant, but also that they’re secure so that you can focus on your business rather than worrying about compliance.
Data protection of digital compliance that strengthens your investment in novel systems and platforms
One of the biggest nightmares for a Life Science company is making the headlines because of a data breach, an event that can damage a pharmaceutical or biotechnology company’s reputation with investors, customers, and the general public.
Avoiding such breaches demands a thorough understanding of systems and how they protect data, conform with regulatory requirements, and meet relevant GCP, GLP, or GMP. Yet layers of regulatory requirements add to the complexity of implementing digital projects. Without a proper framework in place to account for GxP requirements, these projects are prone to misunderstandings and future reinvestments to solve avoidable compliance issues.
GxP-CC’s digital compliance services and data protection can help organizations successfully navigate the layered complexity of life sciences data protection. With a digital GxP compliance framework that aligns with your organization’s business and IT/OT implementation roadmap, Life Science companies can reduce the frustration and expense of digital compliance.
- How GxP-CC can help
At GxP-CC we help companies of all sizes in the pharmaceutical and life sciences industries transform complex GxP validation into a lean and easy process. We create validation approaches for cloud computing and agile development scenarios, which can be used to increase productivity and efficiency.
We also help companies with their data protection by providing regulatory expertise, consulting, audits and training services. By conducting in-depth interviews with targeted stakeholders in GCP, GLP, and GMP to learn about your most valuable assets, we can categorize activities within the most appropriate data protection approach. After our assessment, we create a heatmap of your crucial and impactful assets and provide a solid roadmap for improvement. We support our knowledge in data integrity with leverage of the ALCOA+ principles as part of our digital compliance services and life sciences data protection solution.
- Our digital compliance services
We are experienced in the following:
- Creation of GxP validation frameworks for cutting-edge systems
- End-to-end security maturity assessments
- Data protection assessment based on ALCOA+ framework
- Go further with GxP-CC
We bring to our life sciences subject matter experts in different scopes, including data integrity, security, quality assurance, and system validation. This broad range of expertise is strengthened by experience gained from other regulated industries, offering you powerful support for your digital compliance and data protection demands. We help you overcome your challenges by scaling up your security and uncovering what you need to secure your investments in non-clinical, clinical, and manufacturing settings.