| Record Type | Documents |
|---|---|
| Policy | CAPA Policy |
| Procedure | CAPA Procedure |
| Work Instructions | Vault CAPA Management WI Vault CAPA User WI Compliance Impact Assessment WI Root Cause Analysis WI |
The Veeva Corrective Action / Preventative Action (CAPA) system is aligned to requirements from the EU’s ICH Q10, the US FDA and ISO 9001.
CAPA systems assure Quality oversight of measurable processes to ensure that issues that potentially impact Veeva’s quality models and product quality are analyzed for root causes and effective corrections and preventative measures are instituted to prevent future recurrences.
Veeva includes items that are not gaps in regulated activities such as improvement opportunities, general quality objectives, and business alignments.
CAPA records are analyzed to determine if sources of product and quality information show unfavorable trends or potential product and quality problems that may require prevention or other corrective action.