* “$10.2 billion was the cost related to regulatory infractions by pharmaceutical manufacturers between 2010 and 2012.” by S. Almashat, S. Wolfe, “Pharmaceutical Industry Criminal and Civil Penalties: An Update”, September 27, 2012
When an audit is expected, putting together all the regulatory documentation and checklists is extremely challenging and it can cost up to $280,000
When the audit is underway, it takes on average two weeks, and the resources it draws from your company can go up to $35,000
When the audit is over, if the FDA Form 483 requires corrective measures, and depending on their degree, the opportunity cost can rise to $84,000
Cut down the costs by 60% to 70%
Save up to 50% in time spent
Know who wrote what, when, where and with whom, down to the word level.
Create and manage your documents using doDOC's easy to use interface.
User access control: from batches of documents down to the inidividual paragraph level
Access predifined or customize workflows tied to your company's processes.
doDOC tags your documents automatically as you write them and always knows what is that you're writing.
Searching specific information is enhanced by having all your documents automatically structured. Search specific keywords within specific elements of a batch of documents, such as table captions, table cells or sections.
doDOC allows you to write free form and prepopulated documents. Automatically format data for FDA/EMA forms, such as FDA 1571, 1572, 3674, 3455, 3500.
Use MS Word/Google docs to create documents that are automatically structured by doDOC
doDOC fits "in" the documentation workflow of your company, integrating with existing documentation platforms and enhancing their capabilities and your return on investment done with them.
|doDOC||Specific Solutions||Generic Solutions|
|Information Centric (Robust & Flexible for new regulations)||•|
|Auditability (Track who wrote what, when, where and with whom)||•|
|Concurrent Doc. Editing||•||•|
|Granular Doc. Access Control (down to the word level)||•|
|Automatic Doc. Format (Custom, Medical & FDA)||•|
|Document Lifecycle & Workflow||•||•|
|Audit‐Ready Automatic PDF Reports||•|