Compliance Group

The development of new medical devices or any new project brings a new set of risks. A risk management plan (RMP) must be developed at the start of the risk management process for a new project or device development, according to ISO 14971. However, risks cannot be avoided entirely; they can only be mitigated and anticipated through an established risk management plan. It is recommended that the following components be included when documenting the RMP to ensure that the development and product teams are aligned with the risk management plan and are responsive and agile when dealing with risk impacts. Define the purpose of identifying the risk The scope of the medical device RMP is to identify risks by anticipating potential product development and manufacturing activities from design to market release. To market a device, the organization should review and update the RMP to ensure that the device was manufactured with appropriate measures and is compliant with industry standards for c...

  CAPA CAPA – Corrective Action and Preventive Action is a technique in the quality management system that investigates and tackles quality concerns by identifying and evaluating fundamental root causes and applying corrective and preventive actions. So the life science industry must understand when to launch a CAPA, how to address it, and what process to follow. This blog discusses the differences between Corrective Actions and Preventive Actions, their criteria for initiating a CAPA, how to handle CAPA, and the processes to be followed to be compliant. CAPA (Corrective and Preventive Action) is a methodological strategy for mitigating risk and improving the process. It is done by identifying the sources of potential issues, investigating the root cause, resolving them with corrective actions, defining preventive measures to prevent the issues from recurring, and documenting the entire process to ensure compliance. When to request CAPA? The goal of a CAPA is to avoid and resolve d...

ISO 14971 – Medical Device Company’s risk management standard. Although there are only a few medical device safety measures to consider, ISO 14971 is a widely accepted standard for risk management in medical devices. Risk Management: According to ISO 14971, medical device specifications and risk management processes should be documented. The risk management process is a systematic procedure for identifying, categorizing, assessing, and controlling risks associated with medical design, device manufacturing policies, procedures, and practices. The risk management process is not limited to medical devices; any product development project must include a risk management process and must document the procedures from start to finish. Furthermore, risk management and control are applicable in a variety of situations such as, When a new medical device is developed, or a derivative device is manufactured. Advancement of a specific part of an already released device Modifications to an existing d...

Companies in the life sciences industry face challenges in developing and maintaining data integrity due to complex validation documentation. Maintaining data consistency, accuracy, and integrity across many documents can be challenging. Recently, notable data integrity violations occurred in global pharmaceuticals, biotechnology, and life sciences organisations giving rise to complex data validation in the creation of medical treatments that cure or prevent disease. As Data integrity requires a daily commitment to safeguarding information, it is challenging for life sciences businesses. Data accuracy and reliability are key priorities for regulatory agencies like the FDA. Data integrity problems can be detected and prevented with the aid of flexible, risk-based strategies provided by CGMP guidelines. Companies should deploy meaningful and effective strategies for reducing data integrity risks based on their process knowledge and knowledge of technologies and business models. To mainta...