Products

 Nightly Validation for the same price you are paying for annual validation today  

• Original regulations were designed 25 years ago. 
• Companies primarily rely on manual testing for critical 3rd party systems, making validations an annual event.  
• The shift to SaaS means these critical systems can go through hundreds of changes between validations 
• Waiting a year to find out a critical system is broken is no longer acceptable. 
• A continuous test model is hard to implement inhouse 

•  Validation packages delivered directly to your inbox 
• Know within a day if a critical system is not meeting Quality   expectations 
• Tests are run on our cloud connecting to your test instance 
• A single template for all your validation packages means reduced complexity 
• Automated testing reduces potential for human errors 
• Tests under source control ensure all changes are tracked 
• Use a combination of our existing test library and custom tests to ensure your systems maintain the highest standards of quality 

Automated validation for: 

• Customer Relationship Management 
• Requirement tracking systems 
• Issue Tracking systems 
• Quality management system 
• Reporting tools · CI/CD tools 

 AutomataNow’s Generative AI uses your SOPs to answer audit questionnaires in minutes. In addition, it monitors the FDA to give recommendations on when new guidance might have an impact on your processes and procedures. 

•  With the move from Computer Systems Validation to Computer Systems Assurance, uncertainty is being introduced. 
• Both the complexity of information that needs to be understood and the rate which it is changing is increasing.  
• Internal processes are getting more complex 
• Quality is becoming more dependent on team members outside the quality organization 

•  Incoming audit questionnaires can be answered in minutes including citations of appropriate supporting material  
• When new FDA recommendations are released AutomataNow scans your SOPs to highlight any areas for review/update 
• When supporting material is being submitted to auditors, the document collection can be scanned for internal inconsistencies 
• Fine-tuned model is taught to think like an auditor 

 AutomataNow’s Advanced AI takes all the answers and documents submitted and looks for both internal inconsistencies and non-conformance with FDA guidelines. 

•  The basics are important, but every moment spent on them means less time to dig into the complex. 
• Every company has their own format/thought process for their Quality Management and much of the Auditor’s time is spent learning the target company's approach. 
• The FDA is starting to modify their recommendations more frequently. 

•  Natural Language Processing is used to analyze the SOPs and other supporting documentation to find places where they disagree with each other. The goal being to show Auditors where there might be   interesting discrepancies. 
• FDA updated recommendations are regularly incorporated into the Generative AI domain knowledge to help highlight where companies under audit might now be keeping up with latest recommendations. 
• Quickly scan though object evidence to help ensure Good   Documentation Practices are being applied.  
• Fine-tuned model is taught to think like an auditor