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Risk Assessment Audits

Supply Chain Monitoring

Remediation Services

Due-diligence Audits

Regulatory Responses

Supply Chain Monitoring

Our multidisciplinary team of regulatory and industry experts supported by our proprietary analytics and risk management platform perform continuous monitoring, identification, validation and report risks and issues to the appropriate decision making level. This allows the management of the pharmaceutical company to make decisions for effective detection of risks based on timely identification.The key elements of the solution are:

Ongoing data collection

The technology platform gathers and analyzes critical-to-quality parameters in a non-instrusive manner. This allows near real-time visibility of activities (whether internal or outsourced, local or global) to all supply chain members in a transparent manner.

Risk parameter analysis

Data analytics is used to identify anomalies. The data collected is analyzed through a set of algorithms to identify 'signals' - trends, patterns, and abnormalities.  The solution uses a variety of proprietary analytics techniques that are customized by the parameter characteristics enabling actionable observations from a variety of risk management perspectives.

Anomaly identification

The solution identifies key quality and process parameters and monitors or analyzes them to detect unusual variances – both higher than normal (to ensure that the quality process is in action) and lower than normal (to detect deliberate data manipulations). A team of experts comprising ex-FDA inspectors, technology experts, and GMP specialists will investigate and confirm or refute each anomaly identified.

Risk communication

The first step of risk mitigation is to communicate the risk. The communication could be planned (based on periodic reports) or ad-hoc (based on event occurrences). For example, the Board of Directors/Executive Committee periodically review risks during C-level meetings and take remedial actions. The solution provides a "dashboard" style update, appropriate to this forum at the desired frequency.