LogicGate for Pharma & Life Sciences

Helping transform enterprise processes for the Pharmaceutical industry with LogicGate

LogicGate assists pharmaceutical, biotech, medical device, and life science organizations to effectively identify, manage, and implement changes driven by an ever-evolving regulatory, risk, and compliance landscape. Our technologies help merge people and process to manage risk and reduce cost.

Pharma and biotech companies face rigorous regulatory requirements from federal agencies like the FDA and global regulatory bodies such as the European Medicines Agency (EMA). There are also numerous industry best practices that govern drug development and manufacturing, such as cGMP and ISO standards. We have solutions that can help ensure these best practices are followed, including the requirements detailed in 21 CFR Part 11 regarding electronic records.

Pharmaceutical and Life Sciences Industry

Regulatory, Compliance, & Legal Solutions

in Pharma, Biotech, & Life Sciences

Regulatory Change Management

LogicGate | Regulatory Compliance

  • Enables pharma and medical device companies to implement a top-class regulatory change management program.
  • Analyze, test, and execute regulatory changes to ensure full compliance and transparency. Track and manage impact of regulatory changes by the FDA or other government agencies.
  • Find and eliminate compliance gaps in your organization’s control documentation.
  • Enterprise Risk Management

    LogicGate | ERM Solution

  • Enables corporations to accurately identify, assess, monitor, and remediate business risks.
  • Automates assessment of inherent and residual risk based on impact and likelihood; supports multi-dimensional risk assessments.
  • Captures risk data, including risk details, documentation, questionnaire information, impact, rating, and emerging issues.
  • Build action and mitigation plans with time bound activities, each assigned to individuals within the company.
  • Incident Management

    LogicGate | Incident Management Software

  • Captures events and incidents in a centralized platform to help reduce operational risk.
  • Customized workflow and event handling rules ensures the right parties are involved to address FDA regulations. Assign tasks, investigate reported events, and take corrective actions.
  • Detailed reports and dashboards track status of incidents across the enterprise.
  • Policy and Procedure Solution

    LogicGate | Policy Management Software

  • Provides a central repository where policies and procedures can be created, approved, revised, published, and communicated.
  • Version controls ensure a fully auditable environment.
  • Create custom workflows to support effective controls for new, updated, or decommissioned policies and procedures.
  • FCPA Compliance Management

    LogicGate | FCPA Compliance

  • Centralized, global repository for legal, compliance, and accounting to track, analyze, and approve gift, hospitality, and contributions across the organization.
  • Advanced analytics helps reduce fraud, corruption, and abuse.
  • Getting Started is Easy

    Get in touch with us to see a demo and discuss your specific needs. Take the first step to empowering your process and simplifying your business.

    See LogicGate in Action