Updated on 13 September 2013
Outsourcing integrated IT-KPO document management services: An outsourcing vendor can provide end-to-end Document Management Services in addition to IT support. Many organizations are exploring in-house e-Document Control Centers, which function as a central archive for routing, processing and tracking of incoming records from multiple sites, along with validating and standardizing record templates.
Use of intelligence tools: In an eTMF, documents are acquired and stored electronically. Documents may be acquired from the web or email using digital signatures which have been authenticated. Digital signatures are accepted in place of wet signatures in most countries worldwide, including the USA and the EU, thereby averting the need to scan a document.
Wet-signed or non-digitally signed documents are converted from paper documents to document images by scanners or multifunction printers. Optical character recognition (OCR) software may sometimes be used to convert digital images into machine readable and searchable text. Such OCR solutions may either be integrated into the hardware or available as stand-alone software.
Designing Clinical DMS solution of future
At each stage of the Life Sciences clinical research value chain, workers need to document everything they do.
The solution should be flexible enough to adapt to future needs, trends and innovation without affecting day-to-day transactions. The most critical parameter to consider is that the solution must conform to the boundaries of regulatory compliance. The Clinical DMS should enable Life Sciences organizations to extend their core capabilities by applying project accelerators, best practices, industry expertise, migration, configuration and validation capabilities for clinical documents.
Some requirements that need to be addressed during the construction of a Clinical DMS solution are:
• Enable direct information entry by CROs - CROs should be able to upload documents directly to the web-based platform.
• Clinical Documents Management team should perform a QA role, as opposed to data entry.
• Accurate document indexing- The indexing rules should be automated in the tool as per standards onto staging and long term repository as two different entities. This enables a single window view of information for end users to perform an accurate search of the content repository. A co-existing collaborative document management platform and a more process-centric system will balance user needs and different content applications.