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 ...

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 ...

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 ...

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 ...

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, ...

FDA (Food and Drug Administration) issued a draft guidance to offer recommendations on Computer Software Assurance (CSA) for automated data processing systems that are used as a part of medical device ...

Article Context: Computer System Validation; Risk Assessment; CSA Risk Assessment; Audit Readiness; In the realm of Computer System Validation (CSV), risk assessment stands as a cornerstone in ...

Master the FDA's 5-stage goals for launching medical devices.Compliance Group Guide on strategies for success in regulatory compliance and market entry.

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 ...