Software Validation

DataNinja is a COTS ( Commercial off the shelf) manufacturing system, primarily used by regulated manufacturers as a tool to maintain industry best practices for these areas of their business.

Inventory Management

• Product Lifecycle Management (PLM) and version control of components and subassemblies.
• Supply chain traceability from specific purchase orders, supplier shipments, and lot numbers.
• Inventory inspection.
• Raw materials, subassembly, and finished good release processes and documentation. Ensuring only conforming raw materials are used and conforming finished goods are shipped to customers.
• Traditional inventory management functions to prevent part out scenarios and to maintain automate the financial transactions and implications of inventory-based business activities.

Electronic Manufacturing Records

• CFR 21 Part 11 compliant signatures (required for all industries using electronic systems managed by the FDA and other regulatory bodies).
• Manufacturing execution and automated escalations based on in process permeameters.
• Real time verification to prevent costly manufacturing mistakes such as using expired, non-conforming, or incorrect materials per the master manufacturing record and BOM through real time scan-based verification.

Our customers also leverage our API’s to build custom quality and operations solutions to truly optimize processes and reduce risks and run their businesses.

All of us at DataNinja take the trust and responsibility you have placed in us very seriously and work hard to develop, test, and provide secure and robust business tools. We do this through following industry best practices for software development, automated and manual US based software testing, information security, cloud architecture, dev-ops and client configuration Management.

DataNinja is unique in that it is a native cloud-based web application with all of the benefits that provides (i.e. data security, resiliency, distributed workforce access) AND is able to provide the traditional legacy enterprise benefits of on-premises solutions including the ability to choose when to accept and validate new software releases for the customer's internal use cases. DataNinja, with its tens of thousands of automated tests and dedicated team of test engineers, is responsible for validating the DataNinja solution as a whole. You only need to validate the aspects of DataNinja that you use and most importantly need to validate HOW YOU USE IT. Validating the aspects of DataNinja that you use ensures that your internal standard operating procedures and work instruction documents are maintained to reflect the current business process as well as continued compatibility with DataNinja.

Customer driven validations for the intended use of DataNinja (and keeping records of it) is a recommended best practice for ALL the regulated industries DataNinja serves. It can take time for businesses to develop this software validation for intended use and documentation expertise. Fortunately the Food and Drug Administration (FDA) has updated their guidance on this issue with “The Least Burdensome Provisions: Concept and Principles: Guidance for Industry and Food and Drug Administration Staff” as recently as 2019. Which focuses on using risk analysis and leveraging existing information to use the most efficient means to reduce risk.

The FDA in this document also focuses on the principle of “The Right Time” and “Just in Time Testing” in section C of their non-binding recommendations. This is a recognition to the level of effort that should be placed into the implementation and (more rigorous) initial validation, from the reduced risk and effort invested in validating an incremental software revision. Because software changes are cumulative staying updated and performing incremental validations at “the right time” will ensure that the validation effort will be substantially reduced as compared to validating a long list of changes from several major or minor revisions all at once. Incremental validations will also ensure a more detailed outlook about what matters most for your business.

One of the ways DataNinja encourages this principle is through separating actual software changes (increased risk) from the security and Cloud architecture updates (which decrease rather than increase risk) aspects of the DataNinja platform. You can see this as part of our configuration management numbers in the lower right side of any screen in DataNinja.

First Number is the MAJOR Software Revision --Software Validation Strongly Recommended.
Second Number is the MINOR Software Revision --Software Validation Recommended.

Third and fourth numbers are for internal use and support at DataNinja and contains information about Security patches and cloud architecture updates and are managed exclusively by DataNinja without requiring customer validation.

At your request DataNinja will provide a testing environment with the latest software changes for your review and communication about the changes between your current production software version and the latest software update in an effort to guide your validation activities towards to software changes and business workflow validations instead of server centric security updates.