For those industries regulated by the U.S. Food and Drug Administration (FDA) such as food, drugs, biologics, medical devices, electronic products that give off radiation, cosmetics, veterinary products and tobacco products, software validation is a requirement. The FDA has created specific guidelines related to software validation for health and security related issues. The FDA’s General Principles of Software Validation state:

“Software validation can also reduce long term costs by making it easier and less costly to reliably modify software and revalidate software changes. Software maintenance can represent a very large percentage of the total cost of software over its entire life cycle. An established comprehensive software validation process helps to reduce the long-term cost of software by reducing the cost of validation for each subsequent release of the software.” (Source: FDA website)

Thankfully, Zontec has created an SPC Software Validation Service for customers that must abide by these regulatory standards.

Benefits of using Zontec’s Software Validation Package include:

• Utilizing e-records which are less expensive and more accessible than paper records
• Stronger security by incorporating e-signatures instead of handwritten signatures
• Saving personnel time from developing in-house validation materials
• Increasing productivity and confidence as a result of applying proven SPC software materials that meet regulatory standards and requirements
• Cost of compliance is low compared to recalls, penalties and fines

“One of the things we really like about Synergy and its enhanced reporting capabilities is that now we are able to create the required FDA reports to see how we are operating in real-time.”
—Tim Stutzman of Oregon Freeze Dry