Validated Data Protection for Pharmaceutical Companies
Pharmaceutical companies are under increasing pressure, because of FDA and MHRA focus on data integrity, new legislation such as the EU GDPR and ePrivacy Regulations, and ever increasing risk of cyber-attacks.
ThinkingSafe uses their experience within regulated companies and government clients to help business leaders and technology implementers understand these risks and implement cost-effective solutions to mitigate them.
Our validated data protection services for pharmaceutical companies leverage our core software products and hybrid cloud service platform, which can be easily configured to satisfy the specific requirements of the regulated company and/or the suppliers in their supply chain.
We work with GxP compliance specialists, such as partner Clarity Compliance, to implement a risk-based approach to compliant GxP computerised systems in accordance with GAMP5.
The engagement process may start with specific requirements to implement validated data protection services, or more general requirements to assess the compliance of currently implemented systems against “Industry Best Practice” as interpreted by FDA and MHRA auditors.
For projects that require more exclusive technical knowledge, we work with specialist partners, such as Toro Risk Solutions for their personnel and physical security experience.
Our research, product development, service delivery and operations teams complete the project team, bringing their breadth and depth of expertise in delivering robust and cost-effective Data Protection Services.
We offer a range of data protection solutions for pharmaceutical companies, which include our standard products and cloud services, but also include more specialist solutions for implementing information security across the supply chain.
These specialist solutions include: medical big data processing, data subject opt-in to clinical trials and research, medical device management and secure collaboration, segregated networks for legacy and validated systems, insider risk mitigation and personnel risk management.
The relevant products are:
• Recovery Shield
• Information Shield
• Personnel Shield
The relevant services are:
• Recovery Shield as a Service
• Information Shield as a Service
• Personnel Shield as a Service