Achieving Regulatory Compliance with Automated Reporting

16.03.21

AQP

Complying with regulatory agencies is a challenge that affects training operations in many industries, such as financial, pharmaceuticals, life sciences, aviation, oil and gas – among others. Each industry has its own standards and requirements for training procedures, much of which are related to safety – of the staff, customers, patients, and anyone or anything affected by these activities.

Within healthcare and pharma, the FDA in the U.S, and the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK are examples of regulatory enforcement organizations that have become household names during the approval and roll-out of the COVID-19 vaccines. Each of these administrations has stringent regulations, with complex processes and reporting requirements.

Getting the Timing Right

Most organizations that enforce regulatory compliance require specific reports at precise intervals. All of us are familiar with ‘tax time’ when annual income tax forms must be submitted. Banks, insurance companies and related organizations have to submit to audits on a regular basis, and other reports to comply with financial regulations. Some flexibility exists as to the presentation of the data in various reports, as demonstrated by the variety in quarterly and annual reports by various businesses.

Airlines must demonstrate that they meet the required regulatory standards to be able to operate. The majority of the world’s airlines voluntarily belong to the International Air Transport Association (IATA) which represents close to 300 passenger and cargo airlines in 120 countries. In addition, most countries have specific regulations and requirements. An airline operating in Europe requires EASA compliance, in Brazil ANAC enforces compliance, while in the U.S. the FAA set the standards.

Adoption by airline training programs of the Advanced Qualification Program (AQP) or Evidence Based Training (EBT) offers more flexible training processes, but still requires frequent reports (usually monthly) with clearly defined format and content, posing a significant challenge to civil aviation training organizations. Lessening the burden of generating these reports requires a powerful engine that is able to collect and consolidate data from all relevant systems and create reports in the required format. An advanced training management system that automates this process is critical.

Organizations that operate in more than one jurisdiction may be required to submit variations of their reports for different establishments. Under these circumstances a robust system is critical to be able to map the data correctly, crunch the numbers and automate the production of the formatted reports for each official requirement.

The pace of report submission has also picked up. In pharma and life sciences, annual reports were considered sufficient, until automation and real-time monitoring have enabled product quality reviews to occur much more frequently. Technology enables continuous, real-time monitoring of pharma manufacturing processes to identify issues before they occur on the line. Investigations into companies such as GPT Pharmaceuticals and violations of the company’s quality control unit and failure to comply to the current good manufacturing practice, have highlighted both the need for rigorous reporting, and for robust enterprise-wide compliance training programs.

Leveraging Data

But while regulatory compliance is essential, organizations can also take advantage of the data collected to improve their processes and training operations. For example, an essential component of AQP is the front-end analysis of both training and operational data to establish proficiency objective requirements for all aspects of training. These analytics have benefitted the airlines who collect and analyze the date, and have assisted the industry in general with data-informed, and data-driven improvement.

Similar benefits can be achieved in other regulated industries, with automation of the reports required for compliance, and in parallel leveraging analytics to highlight the information the organization needs to identify trouble spots, and to continually improve its processes.

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