What are the 5 frequent GMP Audit Findings, and How To Avoid Them using eQMS system?

Modern technology has made GMP audits more efficient and reliable. With the advancement of software such as eQMS, companies are now able to systematically monitor and control their quality management systems to be compliant with regulations. eQMS can help spot potential non-compliant practices, eliminating audit findings that could otherwise lead to costly mishaps. In this article, we’ll discuss the 5 most frequent GMP audit findings and how companies can avoid them with the help of an eQMS system.

1. .Unapproved Manufacturing Processes: Ensure that any changes to the manufacturing process are appropriately reviewed and approved by the Quality Control unit and/or other relevant departments. Such approvals are part of the ECO module in Orcanos; changes in WI, Drawings, Parts, Validation, etc., are all controlled by the Engineering Change Order process. Learn more about the ECO/DCO in Orcanos here.
2. Poor Documentation Practices: Put in place an effective and robust document control system, which includes timely document revisions and approvals. Orcanos has a Document Control module that complies with ISO 13485 and 21 CFR 820. A document control system is a system that manages the creation, review, approval, distribution, and archiving of documents within an organization. It helps to ensure that all documents are accurate, up-to-date, and easily accessible to those who need them. Document control systems can be used to manage a wide range of documents, including documents related to regulatory compliance, product development, quality control, and business operations. Document control systems can be implemented using a variety of technologies, including Orcanos software systems that is specifically designed for this purpose, or they can be based on more general-purpose tools such as document management systems or content management systems. Some common features of document control systems include the ability to track changes to documents, assign tasks and review responsibilities, and store and retrieve documents electronically. Implementing a document control system can help organizations to improve efficiency, reduce errors, and maintain a clear record of all documents and their associated processes. It is particularly important for organizations that must adhere to strict regulatory or compliance requirements, as it can help to ensure that all documents are properly documented and kept up-to-date.
3. Insufficient Calibration/Maintenance of Equipment: Develop standardized and properly documented calibration/maintenance schedules for all equipment and ensure they are adhered to and documented. In Orcanos quality management system (QMS), the calibration module is a component that is used to manage the process of calibrating, measuring, and testing equipment. Calibration is the process of verifying or adjusting the accuracy and precision of measurement equipment, and it is an important part of any QMS that is used to ensure the quality of products or services. The calibration module in a QMS typically includes tools and processes for scheduling, documenting, and tracking the calibration of measuring and test equipment. It may also include tools for managing the maintenance and repair of equipment, as well as for tracking the history and status of each piece of equipment. The main purpose of the calibration module in Orcanos QMS is to ensure that all measuring and test equipment is properly calibrated and in good working order. This helps to ensure that measurements taken using the equipment are accurate and reliable, which is essential for maintaining the quality of products and services. It also helps to minimize the risk of errors and discrepancies in measurement results, which can have serious consequences in certain industries, such as manufacturing or healthcare.
4. Inadequate Training: Ensure all personnel is adequately trained and that they have received the necessary refresher training. In Orcanos quality management system (QMS), the training module is a component used to manage the process of training employees and other stakeholders on quality-related topics. Training is an important part of any QMS, as it helps to ensure that all employees and stakeholders are aware of the organization’s quality policies, procedures, and standards and can perform their roles effectively. The Orcanos training module in a QMS typically includes tools and processes for scheduling, delivering, and tracking the training of employees and other stakeholders. It may also include tools for managing the content of training programs, such as course materials, presentations, and exams. The main purpose of the training module in Orcanos QMS is to ensure that all employees and stakeholders are adequately trained and informed about quality-related matters. This helps to ensure that everyone is aware of their responsibilities and can contribute to the overall quality of the organization’s products and services. It also helps to ensure that the organization is compliant with any relevant regulations and standards that pertain to training and quality, such as ISO 13485 section 6.1.
5. Lack of Proper Validation and Verification: Establish and adhere to policies and procedures regarding the validation and verification of processes and equipment.

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