Digital validation tools deliver life sciences manufacturers tools, services, expertise and applications to assure that documents, software, operations infrastructure and processes remain optimized and comply with the requirements set out for specified purposes of their intended use. Tools and services may support specific regulations or requirements, such as the U.S. FDA’s Title 21 Code of Federal Regulations (21 CFR) Part 11 and observed industry best practices (e.g., GxP, cGMP or GAMP). They help in identification, assessment and mitigation of risks associated with the validation process while also facilitating the creation, approval and storage of validation documents. These tools can easily scale with the growth of the organization, accommodating increased validation demands without a corresponding increase in manual effort.