Industries

The strategic challenges facing the life sciences industry, including manufacturing excellence, the emergence of online operations, clinical quality, speed-to-market and cost efficiencies, are common to many product-centric businesses.

However this sector faces uncommon and unique pressures that are otherwise alien to many other businesses. These include increased litigation, product scrutiny, liabilities, strict data privacy laws, and stringent regulatory and corporate governance requirements.

Gemini Security Solutions is expert in providing a range of security solutions to help life sciences organizations achieve their business mission. With a unique understanding of the business processes and regulatory requirements of the industry, our experience includes:

• Developing FDA-validated systems and performing validations
• Developing and assessing 21 CFR Part 11 compliant signature solutions
• Assessments of IT applications and entire business operations for compliance with regulations such as HIPAA
• Digital signature solutions that enable compliance with SAFE-BioPharma Association initiatives