Handling paper-based trial master file (TMF) documentation is cumbersome and time-consuming. The process burdens the organization which has to free resources from other tasks. Also, paper documents can only be retrieved from the physical archive and are not readily available at any other locations. This can be alleviated by implementing a controlled scanning solution that helps to automate the transfer of scanned TMF documents to an electronic archive. The scanning solution is adapted to be in compliance with current regulatory requirements for scanning.
The controlled scanning solution streamlines scanning by offering a standardized integration between the scanner and the eTMF repository.
Key features that help to eliminate risks, involved in using a manual approach are as follows:
Apart from the benefits of making paper-based TMF documents readily available, the scanned documents also makes it far easier to work together across sites and countries, as the TMF documents are available to all employees and stakeholders with access to the eTMF.
The controlled scanning solution is based on a standard Kofax scanner and eTMF functionality, combined with controlled processes. All job configurations in the scanning solution can be applied using configuration files; hence, the solution can be implemented into most eTMF systems with minimal validation efforts.
Being highly configurable, NNIT will be able to implement the controlled scanning solution with minimal effort. Only basic mapping rules and security settings must be applied for the solution to work in a standard eTMF set-up. More advanced features can be added should this be needed, database lookups for property input verification, for example.