It's been said that electronic document management (EDM)
systems for the management of submission documents are "a dime a
dozen." However not all EDM systems are created equal, at least not when
it comes to the management of final submission documents. Many of us are
familiar with the standard functionality that most EDM systems provides
particularly in the life sciences space such as: document types, taxonomy,
version control, lifecycle management, securities, PDF rendering, watermarks,
and electronic signatures just to name a few.
Although the challenges of migrating from paper-based
submissions to electronic are numerous, they are also subjective based on a
company's current infrastructure and culture. The top challenges faced by a
pharmaceutical or biotech company looking to transition to electronic common
technical document (eCTD) format for regulatory submissions often include:
select a vendor / solution, configure system to support specific needs, train
users on system, and roll-out/implement the tools.
To find more information please use the below mentioned link
No comments:
Post a Comment