By analyzing the impact of regulatory changes and updating thousands of documents within minutes, Infinote provides effortless regulatory compliance and FDA package preparation.
Ensure compliance by reducing error-prone processes through intelligent automation
The highly regulated nature of the life sciences industry requires companies to ensure compliance with external regulatory requirements to remain in operation. With regulatory authorities often making changes to these requirements, the process of assessing, analyzing and updating any impacted documents requires considerable manual effort and carries significant risks if not completed correctly. Infinote enables you to locate, analyze and update thousands of documents with 100% accuracy. A process that would previously have taken weeks or even months is now reduced to mere minutes.
Streamline regulatory package preparation by ensuring consistent content across all documents
Infinote enables life science organizations to assess, act upon and audit documents scattered throughout various content repositories, ensuring that the scope and impact of proposed changes is understood and implemented with complete accuracy. With Infinote you can make bulk updates to complete sets of documents quickly and securely. A comprehensive audit trail provides details of all changes ready for any internal or external auditor.
Infinote is used by organisations to radically improve dozens of document-centric processes, including product documentation, installation materials, streamline FDA package preparation, regulatory submissions, policies and procedures, testing methodologies, legal, contracts, and more.
Optimize clauses across all contracts and documentation
With Infinote, companies are able to quickly establish the impact of any proposed policy or regulatory change and understand the impact it will have on their documents, contracts and procedures. Infinote also enables organizations to quickly assess how any changes might affect their regulatory status.
When preparing submissions or other regulatory content, companies also need to ensure that information is kept consistent. By turning your existing content repository into a smart content library, Infinote enables you to create new documents in a consistent fashion. Content is automatically discovered within documents, ensuring that approved phrases and vocabulary are consistently used, improving productivity and reducing error rates.
Hundreds of documents can be updated with a single click, eliminating the need for repetitive and error-prone search-and-replace sessions.
Infinote for Life Sciences
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Infinote offers a host of critical documentation features not found anywhere else.