On April 2, 2026, the FDA issued a warning letter that should be on the desk of every Quality leader in life sciences. It cites several familiar deviations — but embedded in the findings is something ...

In highly regulated industries such as pharmaceuticals and biotechnology, manufacturing is about much more than producing a product. Companies must prove through clear documentation and testing that ...

We’re excited to announce that Compliance Group will be attending the Realize LIVE Americas 2026 conference, happening in Detroit, Michigan from June 1–4, 2026. This premier industry event, hosted by ...

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 ...

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 ...

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, ...

Computer Software Assurance (CSA) is a new methodology that takes a risk-based approach to validation activities. It was driven by the FDA and life sciences industry to streamline verification and ...

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 ...

Bringing medical devices to market is a highly complex, challenging, and regulated process. Medical device manufacturers bear the responsibility of ensuring the safety and effectiveness of their ...

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 ...

Organizations in today’s fast-paced, complex business environment turn to strategic consulting to gain a competitive edge, navigate transformation, and drive sustainable growth. While consultants ...