Progress-EXS Quick Scan for License-to-Operate

Progress Executive Services (Progress-EXS) has added License-to-Operate (cGMP) to its range of Quick Scan tools.

The License to Operate Quick Scan is a risk management tool that allows clients to identify and quantify current and potential gaps in the organization’s compliance with Good Manufacturing practice (GMP) guidelines and other standards as part of an overall gaps, risks and opportunities ‘health check’.

Need for License-to-Operate Scan

As life sciences and healthcare markets become increasingly regulated and competitive, pharma executives spend more of their time asking themselves the same set of basic questions:

• Are we fully compliant with relevant regulations?
• How far are we from slipping into non-compliance?
• Are we overcontrolling, with internal guidelines that are too restrictive?
• Are we overspending or underspending on quality control?
• How can we best monitor return on investment?
• Do we have the right expertise in-house?
• Is our overall license to operate and sell at risk?

Such questions become especially relevant and urgent when companies are bringing new products to market or face threat of product recall. At times like these, they need new eyes on their compliance and quality frameworks and strategies.

How Quick Scan License to Operate works

The Progress-EXS License-to-Operate Quick Scan tool is designed as a ‘temperature check’ on the organization’s overall quality systems, providing an easy-to-visualize assessment on cGMP gaps and risks that might affect compliance and reputation. Use of the tool can also identity opportunities for the future.

After using the Quick Scan, clients can expect to gain the following:

• Full comprehension of the current and expected regulatory guidelines and standards affecting their products, markets and operations
• Visualization of current and potential gaps linked to quality assurance and compliance systems
• Full understanding of the risks that are consequent on these gaps

The end product of the Quick Scan is a full report that rates all findings according to criticality and shapes a risk mitigation plan. Deliverables include an executive-level presentation that summarizes conclusions and recommendations.

License-to-Operate Quick Scan process

The Quick Scan process begins with an initial meeting to determine specific situation and objectives between Progress-EXS consultants and senior project owners, who will act as sponsor of the Quick Scan exercise.

Thereafter, the exercise will move through four steps:

1. Kick off meeting (1day)
2. Technical visit (1-2days)
3. Data analysis and reporting (1-2weeks)
4. Executive presentation of findings (1 day)

Optionally, clients can also ask Progress-EXS to execute the mitigation plan defined by the Quick Scan.