FDA has published final guidance documents regarding validation and development of analytical procedures. On March 7, 2024, FDA published two final guidance documents regarding analytical procedures ...

Most companies, big and small, are subject to an audit at some point. Auditors can focus on one or more areas, such as your financial statements, compliance, tax information or business operations.

The PCAOB has moved two standard-setting projects to the front burner. A project on firm and engagement performance metrics and one on substantive analytical procedures have been moved to the board’s ...

Financial statements comprise three important written records: the cash flow statement, the income statement and the balance sheet. Companies furnish financial statements to provide information on ...

IMGCAP(1)]Documenting audit and review procedures often feels more like administrative than value-adding work. Processing Content And some procedures—like analytics, for example—require more extensive ...

Are you ready for ICH Q14: Analytical Procedure Development and the revision of ICHQ2(R1) Analytical Validation? These guidance’s, intended to be published by 2021, complement Q8 to Q12 and aim to ...

Regulatory expectations and requirements continue to evolve to ensure the quality and safety of drug products. Over the last five years, we have seen increased focus during regulatory inspections ...