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 ...

Evaluation 3. Review the CAPA request to formalize it in the system QRB (Quality Review Board) in an organization evaluates the documented issues to assess their appropriateness and determine the need ...

Organizations must develop a written method to approve papers for sufficiency prior to issuance. Documents should be reviewed, updated as needed, and re-approved. Determine the changes and the current ...

Quality Records and Documents – Non-Conformances (NC), Corrective Actions and Preventive Actions (CAPA), Change Requests (CR), Bill of material (BOM), Complaints, SOPs, Work Instructions, ...

Computer System Validation (CSV) is a critical process ensuring that computer systems used in regulated industries, such as pharmaceuticals, healthcare, and finance, meet required quality, regulatory, ...

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 ...

According to the FDA, change control systematically manages all changes made to a product or system. The goal of the FDA for enforcing the change control process in all life sciences industries is ...

The US Food and Drug Administration (FDA) is responsible for protecting public health by ensuring medical devices’ safety, efficacy, and quality. The agency has developed a rigorous 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 ...

An organised and sequential entry of data supporting change in a project is required for a change control document. It first goes through the change request process, then the change approval or ...