Optimizing the pharmaceutical supply chain with Alert Enterprise Guardian

The protection of pharmaceuticals is vital. But managing security in silos leaves pharmaceutical enterprises increasingly vulnerable to attacks. Whether it’s vindictive action from a disgruntled employee or negligence of a contract worker, a threat at any point in the production process could result in contaminated batches of end product. This yields devastating results like injuries, increased financial costs, adverse impacts on business reputation and in extreme cases, loss of life.

Here’s what the industry faces:

Bioterrorism

Fraud

Cross-contamination

Acts of sabotage

Cyberthreats

What if you could deliver end-to-end protection that covers the entire pharmaceutical production process from sourcing to retail distribution? Alert Enterprise’s Physical Identity and Access Management (PIAM) system extends across IT, OT and physical systems to help pharmaceutical organizations meet the Good Manufacturing Practice (GMP) regulations by …

Monitoring unauthorized configuration changes to Batch and MES for production and processing.

Integrating physical badge access with HR, Directory Services and Laboratory Information Management Systems (LIMS) to protect against research contamination.

Tracing the chain of custody for high-value pharmaceuticals.

Managing contractor and employee access to storage systems to safeguard against drug diversions.

Implementing a unified threat management strategy that helps identify and monitor multiple blended threats, from physical attacks to inside jobs.

Automating compliance across multiple regulations, including HIPAA, HITECH, FDA 21 CFR, PCI DSS and SOX.

Why is a PIAM crucial for pharmaceuticals?

Contamination prevention
Inhibits access for unauthorized personnel to ensure product quality and safety

Data integrity and reliability
Controls access to laboratories to safeguard the integrity and reliability of test results

Product quality and safety
Eliminates unauthorized access to storage facilities, cleanrooms and critical process areas to uphold safety standards of regulated products

Documentation security
Prevents documentation tampering to avoid compromising the manufacturing and quality control processes

Regulatory compliance
Guarantees adherence to quality standards by ensuring access controls are in place and auditable

Sabotage or malicious acts
Mitigates the risk of intentional harm by controlling access to sensitive GMP areas

Get a dose of cyber-physical medicine

Discover how an automated, converged approach can help mitigate threats to pharmaceuticals while giving your security team a comprehensive view of risk.