Compliance Group Inc. is excited to announce its upcoming webinar premiere “Where Are You with Your CSA: An FDA, Industry, and Compliance Group Perspective” on October 2nd 2024 at 11:15 AM EST. This ...

So, Quality Management System has produced a step-by-step process to help companies handle the CAPA process to get satisfactory results in adherence to ISO (International Standards Organization) FDA ...

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 ...

In the life sciences industries, documentation plays a crucial role in proving the product’s effectiveness and safety. Furthermore, it discusses the processes and practice’s dependability, ...

Change management is when an organization creates a step-by-step protocol to manage and implement modifications to products and processes. A change management plan is a protocol that implements and ...

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

In the intricate landscape of regulated industries, the synergy between Computer System Validation (CSV)/Computer Software Assurance (CSA) and Cybersecurity principles emerges as a critical ...

For health and life sciences organizations, compliance with regulatory requirements is non-negotiable. Historically, Computer Systems Validation (CSV) has been the focus of QA and compliance ...

The different processes involving multiple roles like supplier, production, manufacturer, and pieces of equipment for designing or marketing a product will inevitably invite some non-conformance ...

ISO 13485:2016 is an international standard for medical device manufacturers and providers of quality management systems. ISO 13485:2016 is not a law or regulation and is voluntary, while FDA 21 CFR ...

FDA (Food and Drug Administration) issued a draft guidance to offer recommendations on Computer Software Assurance (CSA) for automated data processing systems that are used as a part of medical device ...

From hearing aids to ultra-tech pacemakers, the medical device industry is a ground-breaking and innovative field full of opportunities. Though the manufacturers are passionate about delivering ...