Document based vs content based

Getting your regulatory data in an orderly fashion can be a lot of work - finding, sorting and entering information into meddevo is a necessary step that can, depending on your starting point, be time consuming in the beginning.

But luckily you can even benefit from meddevos features before you found time for all that - via the document based approach.

Document based digitalization means, that you upload your current TD as it is, as finalized PDF documents or Word files into the system. While this will not help remove data redundancies and inconsistencies, it will lift the burden of navigating endless (and possibly also redundant!) folder structures on your server. You can upload new versions when they become relevant, thereby use the version control and all advantages of the submissions feature are available to you. While this does not unleash the full potential of meddevo, it is easily implemented within a day, giving you the fastest return on invest thinkeable!

Content based digitalization means that relevant information from the TD no longer hide in documents but have been picked out and added to the meddevo collections. This approach makes it possible to fully utilize all meddevo functions, but also requires a initial time investment. While not obvious on the first glance, during the process it quickly becomes evident that digitalization also means standardization. meddevo helps you with this by providing you with pre-defined frameworks. But standardization can also mean, that certain areas need to be adapted or changed and some redundancies will in the end always need your own regulatory experience - for example: When transferring information from documents to meddevo, it is necessary to check whether the indications listed in the CER and in the PSUR are identical (or in other documents) and if not, which of the versions shall be used in the future. Of course, you don't want to transfer the data inconsistency and the resulting errors from the old documentation to the new digital structure. 

Of course those two approaches are not a either-or but while starting with a document based digitalization you can then move on to the content based digitalization! But we know how overwhelming the data clean-up step can be - get in touch if you want our help picking the super low hanging fruit of the document based digitalization first!