Explore how digital transformation is revolutionizing the life sciences industry. Learn how Compliance Group Inc ensures ...

In this webinar, experts from Compliance Group Inc., Getinge, and Flex will explore how organizations in the Life sciences industry can meet evolving regulatory expectations while embracing Digital ...

Article Context: Change Management Change Management Process Change Request Review How to Manage the Change Management Process? What is Change Management? Change management is when an organization ...

CAPA PROCESS STEPS The CAPA process comprises seven steps as highlighted below. Step-by-step risk-based CAPA process Identification Evaluation Investigation & Analysis Action Plan Review and ...

Article Context: ISO 9001 QMS ISO 9001 Documentation Requirements ISO 9001 ISO 9001:2015 requires a list of obligatory documents. The QMS ‘s scope will include the following: Policy on quality. Goals ...

Article Context: Packaging Sterilization Testing Process Optimization Packaging and sterilization validations are a critical step in the development and manufacturing of medical devices, as they ...

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 ...

Article Context: Quality Records and Documents ISO 9001 Quality Management Principles What is record linking, document linking, and record-document linking? Importance of Record Document Linking ...

Article Context: AI/ML Operational Lifecycle AI/ML Implementation in CSA/CSV Development of AI/ML (Artificial Intelligence/Machine Learning) technologies has raised concerns regarding regulatory ...

Article Context: FDA 21 CFR Part 820 (vs) ISO 13485 (2016) Similarities between FDA 21 CFR Part 820 and ISO 13485 (2016) ISO 13485:2016 is an international standard for medical device manufacturers ...

Article Context: Preclinical Research FDA Medical Device FDA Post-market Surveillance Bringing medical devices to market is a highly complex, challenging, and regulated process. Medical device ...

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 ...