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 ...

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 ...

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 ...

Packaging and sterilization validations are a critical step in the development and manufacturing of medical devices, as they ensure patient safety, regulatory compliance, product quality, and the ...

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

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 ...

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 ...

One of the most important requirements for regulatory compliance within the life science industry is the creation and maintenance of an audit trail. An audit trail is required for regulated ...

Development of AI/ML (Artificial Intelligence/Machine Learning) technologies has raised concerns regarding regulatory compliance. CSA/CSV (Computer Software Assurance / Computer System Validation) ...

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 life sciences industry has primarily focussed on quality practices and procedures to focus on the customer needs and upon their internal efficiency to compete effectively in the market with goods ...

Regulatory Data Integrity findings are on the rise due to the exploding increase of data from electronic and manual data collection systems. A sample analysis of Data Integrity warning letters reveals ...