How to build and implement an eQMS: efficiency, compliance and data integrity – Replay

Applications / Use cases / Air Transport Regulatory Compliance Solution

Client Project 

Air transport regulations data management application.

  • Elimination of Excel®
  • Simplified Audits
  • Increased Productivity
  • Quality Improvement
  • Enhanced Collaboration
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international airline carrier streamlined regulatory compliance by replacing Excel® with a GxpManager application.

Context of the digitalization request

Our client is an international airline carrier. For regulatory compliance management and risk control, the client uses Excel® files. These files contain a list of all the standards and regulations that the company must comply with:

  • IATA (International Air Transport Association) standards
  • IOSA (IATA Operational Safety Audit) standards
  • EASA (European Union Aviation Safety Agency) standards
  • FAA (Federal Aviation Administration) standards
  • National regulations
  • Other internal regulations and policies

These regulations define the technical requirements and administrative procedures related to airline operations, as well as the applicable requirements for flight and cabin crew.

Issues related to the use of Excel®

The Excel® files have become very large and difficult to manage for our client:

  • Thousands of rows make navigating and searching for information in the Excel® files tedious and time-consuming.
  • The multitude of fields (in columns) increases the complexity of visualization.
  • Lastly, numerous duplicates unnecessarily inflate the files, adding to the complexity of their use and updates.

The client's need

Convert 4 Excel® documents, containing a total of 12,000 rows, into a single GxpManager application to centralize information and facilitate regulatory data search and management.

  • 1st step: Data processing
    Centralize, reorganize all data, and eliminate duplicates.
  • 2nd step: Build a custom GxpManager application
    with the injection of the data processed in step 1.

The application solution

A close collaboration between our client and the GxpManager techno-functional consultant enabled the data processing and the development of a custom application within 10 GxpManager service days for a total project duration of 4 months (from project initiation to delivery).

The 12,000 rows were reduced to approximately 3,600 by reorganizing the information and eliminating duplicates.

The application allows specifying for each regulation:

  • The internal departments and responsible individuals: monitoring manager, expertise manager, etc.
  • The effective date
  • The reference of associated documentation
  • Regulatory monitoring
  •  

Bespoke Applications

GxpManager

More information

Features

  • Advanced search tool
  • Audit trail: every data addition, modification, or deletion is tracked
  • Access management: 90% of users have limited read-only access, while 10% have administrator access and can make modifications.

Agility

Our client now has an agile application that can easily evolve according to their needs. The GxpManager application’s potential for growth is vast; here are a few examples:

  • More advanced Quality Management with Non-Compliance management and CAPA (Corrective and Preventive Action Plan) tracking through custom workflows.
  • Audit management: implementation of planning and tracking tools for audits and associated corrective actions.
  • Regulatory monitoring tracking.
  • HSE (Health, Safety, and Environment) management tools.
  • Risk analysis tools.

Results

For our client, the benefits of replacing Excel® files with a compliance management application are multifaceted:

  • Time and productivity savings
  • Simplified audits
  • Improved Quality Management
  • Centralized information in a single point: facilitating collaboration between different departments
  • Data capitalization: the valuable information in the Excel® files was underutilized. With the transition to GxpManager, the client can now effectively analyze and utilize their data with ease.
  • Traceability of every data modification through the audit trail
  • Improved overall visibility
  • Enhanced user experience
  • Easier maintenance of regulatory compliance.

Client feedback

Our client particularly appreciated the swift implementation and responsiveness of the techno-functional consultant who deployed the solution.

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