Regulatory Compliance Management

Recent ISO data shows a growing number of certificates being issued across all standards. A  notable increase is especially seen in ISO 9001 (Quality Management), ISO 14001 (Environmental [...]

In September 2022, the (FDA) released draft computer systems assurance (CSA) guidance clarifying software validation requirements for medical device manufacturers. The guidance significantly [...]

In FDA and ISO environments, quality audits are a process of examination and substantiation that procedures, records, and activities are effectively aligned with desired objectives. The FDA and [...]