Version control is required for documents involving processes, procedures, and best practices that undergo revisions and redrafting to maintain regulatory guidelines and compliance. Throughout the ...

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 ...

As the English saying goes, “Potato, Potato” doesn’t translate well in the written form. Still, it’s saying the same vegetable but with a different pronunciation, meaning it doesn’t matter how you say ...

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 ...

Build all of the ERES requirements into your Requirements Specification template. Include appropriate subsections: Open Systems, Closed Systems Audit Trails; Nonbiometric Signatures, Biometric ...

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 ...

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 ...

In the realm of Computer System Validation (CSV), risk assessment stands as a cornerstone in ensuring the safety, efficacy, and compliance of software systems, particularly in regulated industries ...

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 ...

CG has skilled professionals with over 100 years of combined QMS experience. CG can optimize your QMS to align with today’s requirements, ensuring compliance to your regulatory needs globally. “CG has ...

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 ...

As the pace of digital transformation and automation accelerates, the need for a robust and lean risk assessment methodology for software is becoming more and more critical in the life sciences ...