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Solutions » Industry Solutions » Pharmaceuticals

Industry Solutions

Pharmaceuticals

Overview

Many companies in the Life Sciences and Pharmaceuticals Industry are feeling the crushing burden of operating in a highly regulated environment. In addition to SOX compliance required for public companies, they have to deal with FDA compliance, DEA rules, not to mention process-related controls and access controls related to ERP applications, legacy applications and IT security tools. Change control processes as well as designated role assignments mandated by FDA 21 CFR Part 11 and various sub parts require establishing controls and compliance procedures to avoid heavy fines and criminal penalties.


A more comprehensive view of risk involves a combination of IT risk, risk of access to facilities and assets and risk of change to lab and production processes. AlertEnterprise delivers a single unifying solution that extends across IT applications like ERP, GRC and IAM as well as physical security applications and production processes, delivering true security and business alignment by hiding the complexities of integration.


Pharmaceuticals Industry AlertEnterprise

Challenges

  • Lab Research and Drug Discovery – protect information, monitor access, detect insider threat, eliminate cross-contamination
  • Manufacturing Processes – compliance with FDA 21 CFR Part 11 and all sub parts. Change management controls for pharmaceuticals processes.
  • Supply Chain Management – material movement for controlled substances, theft and drug diversion
  • Critical Security Risks for Life Sciences – critical facility access, insider threat, bio-terrorism

Solutions

  • Prevent cross contamination by correlating physical and logical access
  • Protect intellectual property with access re-certification and roles-based access control
  • Automate Multi-Reg. Compliance to include FDA 21 CFR Part 11, CFATS, NIST, SOX, HIPAA etc.
  • Correlating Process Changes to Physical and IT access
  • Monitoring Access to High Risk Areas, validate training, certification and safety awareness
  • Monitor process change management

Solutions Benefits

  • Single unifying security application the extends across IT security, physical security and production
  • Reduce compliance and audit costs while actively enforcing policies
  • Detect, notify and prevent incidents including theft, sabotage and acts of terrorism
  • Geo-spatial monitoring for effective control, response and risk remediation
  • Most comprehensive view of risk combining logical and physical security with location based context