Do you have strict requirements for quality and safety, with equally strict procedures required for meeting them? Is your industry regulated by the U.S. Food and Drug Administration (FDA)? FDA software validation is one way to ensure the tools you use when creating or distributing products are up to the task. But software validation isn’t only for companies who need to maintain compliance. It’s also a good business decision for any organization that wants to improve quality standards and prove critical software is operating the way it should. However, FDA software validation can be a complex process. The FDA requires that it be done, but it doesn’t tell organizations specifically how to do it. Their published recommendations are long and complex, and not all of the guidelines apply to every business — so how do you know where to start? Auditees are required to submit statements of accounts reflecting all financial management for a designated period, with documentary evidence, to the Board according to the Regulations on the Submission of Accounts enacted by the Board to verify the accuracy, legality and reasonableness of such financial management. Manufacturers are constantly provided with the guidelines to be considered to be applicable to the validation of medical device software or the validation of software used to design, develop, or manufacture medical devices SOME FIRMS HAVE DISCOVERED that by working smarter they can maintain—and even improve—quality while enhancing profits by cutting back on the hours they invest in audit engagements. A new survey spotlights some of these best practices at firms known for their excellent controls. THE FIRST STEP TO ACHIEVING AUDIT efficiency is to manage and train clients. CPAs work best when clients provide them with the data they need. Many firms have different strategies for educating their clients about their needs, but most such strategies pay off. RETAINING CLIENTS AND STAFF ALSO can increase audit efficiency. Firms found that greater familiarity with a practice area and a client enabled them to streamline their audit approaches and make the most of the time spent on each engagement. PLANNING PROPERLY IS CRITICAL to audit efficiency. Many firms review the prior year’s workpapers to familiarize themselves with client issues and to seek out past inefficiencies and possible improvements. Using AuditMagic Software, you are provided with various checkpoints and standardized suggestions that automatically verify you current practices against the potential infractions conducted in practice & procedures.
Do you have strict requirements for quality and safety, with equally strict procedures required for meeting them? Is your industry regulated by the U.S. Food and Drug Administration (FDA)? FDA software validation is one way to ensure the tools you use when creating or distributing products are up to the task.
But software validation isn’t only for companies who need to maintain compliance. It’s also a good business decision for any organization that wants to improve quality standards and prove critical software is operating the way it should.
However, FDA software validation can be a complex process. The FDA requires that it be done, but it doesn’t tell organizations specifically how to do it. Their published recommendations are long and complex, and not all of the guidelines apply to every business — so how do you know where to start?
Auditees are required to submit statements of accounts reflecting all financial management for a designated period, with documentary evidence, to the Board according to the Regulations on the Submission of Accounts enacted by the Board to verify the accuracy, legality and reasonableness of such financial management. Manufacturers are constantly provided with the guidelines to be considered to be applicable to the validation of medical device software or the validation of software used to design, develop, or manufacture medical devices
Using AuditMagic Software, you are provided with various checkpoints and standardized suggestions that automatically verify you current practices against the potential infractions conducted in practice & procedures.
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