As new technologies continuously push the limits of medical devices and drugs, regulations and governing bodies must maintain applicability amidst an ever-evolving industry. As new treatments, devices, drugs, and more are researched and developed, the way they are regulated must constantly change and adapt to the current scope of the medical industry. In doing so, the FDA, ISO, and other governing standards organizations periodically update their regulatory standards. When a standard is updated, the governing body will not come knocking on an organization’s door, laying out the changes and mapping out a plan to update a company’s quality system and procedures, that is the sole responsibility of an organization.

Maintaining current compliant standards within an organization, including a quality management system, is a requirement of every regulatory body. When a new guidance or governing document is released, organizations will usually have a grace period to ensure they are allotted enough time to ensure full, updated compliance. Now, the first thing most organizations think of is “What’s new in the regulation?”, and attempt to update their standards and systems via the addition of verbiage, clauses, etc. The issue with this approach is that, although new clauses may be added or incorporated to comply with new regulations, the previous clauses and standards in the system may not be up to date anymore or might contradict some of the newer clauses. Therefore, a thorough and detailed review of the current competencies as well as deficiencies in compliance with newly released regulatory standards, a gap analysis, is highly suggested.

A gap analysis is a detailed review of a quality management system, including but not limited to, all levels of documents from manuals to templates to records. A gap analysis assesses the competency of a current management system and how it adheres with the requirements of a standard or regulation. For example, when the newly revised ISO 14971:2019 was released, and even to this day, EMMA has been performing gap analyses of many organizations previously established and certified QMS’s to the newly incorporated regulations. Gap analysis consists of thorough documentation of where a quality system is in terms of compliance and what changes it requires to maintain full compliance. A gap analysis is highly recommended for an existing QMS, as it doesn’t require the full rework of an entirely new system, but rather introduces the changes necessary to update the QMS. Therefore, personnel and employees who are already familiar with and trained on the QMS will not be introduced to an entirely new one, but rather notified of changes to the same underlying foundation in the QMS.

A gap analysis is a critical step in maintaining continuous compliance with governing bodies such as the FDA. It can not only expedite the process of compliance with a new standard but can also save an organization a lot of expenses involved in failing an audit or certification. If your organization’s QMS needs an update, a gap analysis is the best place to start!

Looking for a gap analysis to ensure compliance? Get in touch with EMMA International to speak with one of our experienced professional consultants! The EMMA team is here to provide you and your organization with all the regulatory affairs and quality management skills necessary to ensure your organization’s success. Call EMMA at (248)-987-4497 or email us at info@emmainternational.com to learn more!

Kareem Arafat

Kareem Arafat

Quality Engineer- Mr. Arafat has experience in combination products, pharmaceuticals, and FDA compliance for many life science industries. He has experience with many different elements of quality and regulatory compliance. Mr. Arafat holds a Bachelor of Science in Materials Science & Engineering from Michigan State University.

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