The author discusses the collection and evaluation of data part of FDA’s definition of process validation. Process validation is more than just running three consecutive batches under manufacturing ...

Statement on Quality Management Standards No. 1, A Firm’s System of Quality Management, becomes effective on Dec. 15, 2025, and the required documentation surrounding that system’s design, ...

In June 2022, the AICPA’s Auditing Standards Board (ASB) and Accounting and Review Services Committee (ARSC) issued interrelated final standards on quality management intended to clarify and improve ...

How often and how much does your firm think about quality? Every auditor is, by nature, committed to quality. Every firm has final quality control steps built into its production process. However, ...

In recent years the focus on and importance of quality management has intensified. Market demand for product quality, safety, serialization, and total traceability has increased as the risk of lost ...

Companies put internal controls in place to limit risks. Possible risks include losses, poor performance on contracts, poor quality and non-compliance with regulations. Documentation procedures detail ...

Strictly speaking, if you have a rigorous quality process in place, there should be no reason for a discussion of rework. In fact, it might be said that rework is the result of not having rigorous ...

A PQRI expert working group provides case study examples of risk-management applications. The harmonized Q9 Quality Risk Management guideline from the International Conference on Harmonization (ICH) ...

The ability to manage and process information has become paramount to business success, and document management software (DMS) has played a critical role in this information revolution. As the founder ...