USDM CLOUD ASSURANCE

Owners

Goods & Services

Providing educational programs in the life science fields using on-line activities, non-downloadable webinars and blogs, workshops, and printable materials distributed therewith featuring end-to-end GxP (Good Practice) cloud compliance from implementation through ongoing validation maintenance of new releases

Business advisory, development, and strategic planning services provided to companies for business purposes in the life sciences industries; Business consultation services in the field of GxP (Good Practice) compliance; Business consultation services in the life sciences fields pertaining to end-to-end GxP (Good Practice) cloud compliance from implementation through ongoing validation maintenance of new releases; Business consultation services in the life sciences fields for the following activities: product data integration into a modern Quality Management System (QMS) to create more efficient workflows; clinical collaboration in a GxP compliant environment; Computer Systems Validation (CSV); document management systems; enterprise content management systems; workflow and eSignature approval streamlining; digital transformation strategy and roadmapping and application consolidation, including email, document management, file transfer protocol (FTP) servers and file share drives; merger and acquisition standardization and harmonization; GxP compliance for government regulatory audits; reducing implementation and validation time; harmonizing and centralizing GxP cloud compliance; cost reduction for managing cloud compliance; new release management for continuous cloud compliance; scalable vendor solutions for establishing compliant IT foundations; vendor audits targeted to current processes, technology, and manufacturing; implementation and validation of GxP compliant changes, including regulatory assessment, creation of validation plans and reports, drafting of user requirements and functional specifications, risk and impact assessment, developing IQ/OQ/PQ protocols and test scripts, developing user and administration SOPs; continuous GxP compliance, including managing new vendor releases, conducting impact assessments, updating validation documents, running automated regression tests, and providing continuous analysis and reporting