Pharmaceutical Technologist - November 2007 - (Page 22)

Perry // regulatory bodies) developed the first guidelines for e-submissions, regulatory affairs professionals had to contend with the challenges of gathering and managing documents from disparate functional groups including clinical, nonclinical, manufacturing and drug safety. This information then had to be organized to facilitate the bidirectional exchange of information between the applicants and the regulatory agency. For both the industry and regulators, the implementation of standards in electronic submission formatting was a welcome relief from the previous ad hoc, nonstandardized submission process. long gone. An electronic document management system (EDMS) — also referred to as a content management system (CMS) — has replaced the labour-intensive spreadsheets in controlling the submission and compliance process. A compliant EDMS, properly configured, can track when documents need to be submitted. It can also tell when different versions of a document are submitted and what amendments have been made to existing files. competition among pharmaceutical companies, an EDMS could make the difference between being bought, and accelerate and increase the deal size by a significant amount. PT Warren Perry is a senior compliance adviser at QUMAS. The value of EDMS Today, an EDMS is not just for archiving and storing documents; it must bring value to the content stored, as well as automate the many functions that were traditionally managed manually. Table 1 contains some examples of the features found in the better EDMSs offered on the market today and how they can play a vital role in automating, organizing and reducing the complications inherent in the daily tasks of a life sciences company. A comprehensive EDMS provides easy access to information created by the function groups, and facilitates the bidirectional submission and compliance process. The demise of spreadsheets From the time an investigational application is submitted, until the time the marketing application is complete, there are often hundreds of documents filed. This makes it difficult for the reviewer, who must be certain he has the most recent and effective information on the product, and the sponsor, who must manage the previous information that was submitted and the reasons for each update. A lack of communication about critical updates, such as site enrollment information, changes in protocols or submission of adverse events, often leads to failure to comply with the agency guidelines, particularly those related to the reporting periods. This can lead to an extended reporting period, increased scrutiny from regulatory officials and additional costs to bring the product to market. Fortunately, the days of using spreadsheets to track submitted documents and amendments are Foundation for success Finding the right documents in a timely and efficient manner can significantly accelerate the time to approve, publish and submit critical ‘controlled’ documents. A start-up biotech can choose whaich EDMS best fulfils its needs and processes. Once the system is in place, the start-up biotech will be better placed to present the most up-to-date documentation quickly and easily. With intense 22 November 2007 l pharmaceutical technologist

Table of Contents Feed for the Digital Edition of Pharmaceutical Technologist - November 2007

Pharmaceutical Technologist Contents Editor's Comment News Morpheus Feeling the Pressure Legal Crusaders The Holy-Grail of Start-Up Biotech Special Feature Q&A

Pharmaceutical Technologist - November 2007

For optimal viewing of this digital publication, please enable JavaScript and then refresh the page. If you would like to try to load the digital publication without using Flash Player detection, please click here.