Not all risks will be solely mitigated by the software, some risks are mitigated procedurally.Typically a design specification is not required for a purchased configurable business quality system.This article provides answers the top five most common software validation and documentation questions asked by others in FDA regulated industries and demonstrates best practices for meeting the guidelines. The FDA mandates that software used for the design, manufacture, packaging, labeling, storage, installation, and servicing of all finished devices intended for human use shall be validated.While ISO (International Organization for Standardization) and SOX (Sarbanes-Oxley) regulations are not as clear about the validation process, they do require that software development lifecycle processes be followed in areas where they apply because software validation demonstrates evidence which provides a high degree of assurance that a specific process will consistently produce the expected result.Together we fill out standard templates taken from my book.Projects are typically completed in one-third the time of any other approach.Information such as what work instructions are used to train users to use the system, what system support is available, how the system will be backed up, and how change control will be managed are extremely important elements captured in this document.In essence it puts a bow on the validation package.
a more traditional FMEA risk assessment for software programs which are part of a device and pose direct patient risk.The Requirements Specification also needs to include information around physical hardware requirements, physical software requirements, client user requirements, training requirements and detail about any customizations or integration with other systems.This required document provides a visual layout of how the system is configured on the network.This means the system is up and running with trained users in a third of the time too.The result is increased employee efficiency and your company is now more productive.The validation report should provide a summary of all documentation associated with the validation of the software and test case results.This report should include both a summary of all the validation activities and define how the system will be managed in production.Many times software vendors will try to sell prepackaged validation documentation.Because a vendor selling a prepackaged validation does not know your requirements they try and list every functionality that the system has and let you whittle down the list of requirements based on your use of the system."As your consultant I will provide personalized service for each member of your team so they learn how to work together and with computer systems to maximize productivity.I will promote your education and experience so that your company is compliant with regulatory requirements and is self-sufficient." – David Nettleton …consider that David Nettleton has completed more than 240 software validation projects working step by step with the people that actually use the software.