Software validation confirms that certain specifications coincide with user needs, the software is meeting intended use and requires objective evidence that the requirements can be consistently fulfilled. This is required for any company covered by the Food, Drug and Cosmetic Act and 21 CFR Parts 210 and 211. Also, if a company is keeping current Good Manufacturing Practice (cGMP) data electronically and relying on that information to make cGMP decisions, they are required to
perform software validation. Manufacturers who continue to see increased enforcement of these regulations include pharmaceutical, nutritional supplement and cosmetic companies.
For small to mid-sized manufacturing companies, software validation can seem like an overwhelming task. However, the benefits of validating prove to be well worth the cost. Some of the reasons for software validation include:
• Saving money by discovering weaknesses or flaws in processes prior to production
• Providing management with a clear understanding of risks so that appropriate decisions can be made
• Increasing the likelihood projects will be completed on time and within budget
• Increasing product and system quality
• Meeting regulatory compliance
Creating a software validation plan before commencement will save you time and money and make the undertaking manageable. It’s important to find a validation team that has the time and decision making authority to follow through each phase.
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