Integrated Quality Systems Simplify CAPA Management, Mitigate Risk and Maintain a High Level of Compliance within Life Science Organizations
In today’s volatile climate of increased regulatory oversight, media scrutiny and widespread recalls, even the hint of a product’s failure or a procedural error is enough to damage a company’s reputation and negatively impact its bottom line. Life Science companies are especially vulnerable to these risks given the nature of their products and the intense regulatory burdens under which they operate. Failure to meet government and industry regulations can result in punitive events, namely audits, fines, warnings and lawsuits, that adversely affect a company’s productivity and ability to conduct business. Special attention has been given to Corrective and Preventive Action (CAPA) violations in recent years. This white paper by Pilgrim Software points out that quality systems must encompass the majority of their company’s processes in compliance with CAPA.
| Published: | 2008 |
| Format: | |
| Length: | 6 pages |
| Type: | White paper |
| Language: | English |
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