The Switzerland-based pharmaceutical company struggled with managing international regulatory compliance issues. E Com Security Solutions’ “One Audit” approach enabled the organization to
perform a single audit and comply with multiple standards, including GDPR, SOC 1, SOC 2, ISO 37001 and ISO 27001.
The Challenge
The organization upholds its mission to create life-changing value and bring smiles to patients by providing medication for diseases lacking effective treatment. The organization is committed to research and development, striving to give medicines to patients with intractable diseases and rare conditions. The organization has expanded its value chain extensively across global markets, experiencing rapid international growth and thus increasing its need to manage global regulatory compliance. The organization aims to provide pharmaceutical products to patients to address unmet medical needs, and achieving this goal would not be possible without addressing this issue.
It has 18 consolidated subsidiaries worldwide, and its global business is structured as a matrix organization. Various divisions are involved in the value chain for supplying pharmaceuticals to the market, including R&D, manufacturing, quality assurance, regulatory affairs, and pharmacovigilance. The organization’s value chain extends worldwide, and disruption to these business processes would introduce significant risks.
The Solution
A team of E Com Security Solutions cyber security and data privacy specialists with experience in domestic and international started working with the organization as one team to help resolve issues, including its cross-border data transfer issues and, by extension, its overall business management issues about global regulatory standards. The project team began with identifying and organizing tasks related to cross-border transactions and other overall regulatory standards. E Com Security Solutions also deployed an internal Vulnerability Management service and annual compliance management exercises, and compliance and certification with industry standards, including GDPR, SOC 1, SOC 2, ISO 37001, and ISO 27001.
Results
“A system compliant with regulations can be elaborate to the point of limitlessness,” the Organization LT mentioned. E Com Security Solutions team focused on building a realistic regulatory compliance framework that rationally incorporated the essentials.
E Com Security Solutions’ – Compliance Management
For more than 15 years, E Com Security Solutions has been at the forefront of compliance. Our One Audit solution enables organizations to perform a single audit and comply with multiple standards and regulations.
We accelerate your path to third-party assurance and certification of AICPA SOC 1 and AICPA SOC 2, ISO, PCI DSS, HIPAA, GDPR, CCPA, FFIEC/GLBA, NYDFS, CJIS, and FISMA with our specialized advisory and assessment services. We allow you to build a strong governance structure and manage compliance. You get our experience, systems, and tools to simplify compliance, no matter your industry. You keep complete control of audits and can feel assured that you are ahead of any changes in regulations—before they occur.
