Document Management Traps: Five Common Pitfalls You Can Avoid

Held April 22, 2009

How many of these pitfalls and traps sound familiar?

  1. We employ multiple systems, creating “silos” that make it difficult to search and retrieve documents.
  2. We rely on a simple — yet restrictive — collaborative workplace program to manage our documents, and there’s reluctance to change.
  3. We hesitate to migrate documentation from newly acquired products or licensing deals because we’re worried about how it will affect the DMS.
  4. We let our eCTD vendor manage submission documentation, but last-minute changes never seem to get integrated back into the DMS.
  5. We keep plowing more money into a system that doesn’t deliver an effective ROI.

Regulatory software experts Jill Iacopi and Lee Knoch will illustrate how companies can avoid the most common pitfalls and increase efficiency and milestone achievements, as well as avoid regulatory sanctions, through the use of an appropriately designed document management system.

Using cases studies, attendees will be guided through examples of how firms tackled and overcame their biggest DMS challenges.

Order now for your entire team to listen in and discover:

  • The value of a document management system as it applies to regulatory compliance
  • The key steps to take when purchasing a new document management system or reviewing your current one
  • A real-life case study of how companies, using the right document management system, can improve their milestone achievements 
  • How the size of your company, capabilities of the in-house IT department and budgetary concerns affect the kind of system you need
  • The basic qualities a document management system should have — are its version controls, electronic signatures and review cycles up to your standards?
  • How a document management system can streamline due diligence and help you avoid Form 483s and warning letters.

Learn the benefits of document management systems and how the right one can help with FDA electronic requirements and ensure compliance with agency regulations.

This audio CD/Transcript is a must for drug and biologic firm employees responsible for ensuring their document management systems meet the FDA’s expectations for electronic submissions, including:
  • Compliance officers
  • Senior management
  • IT professionals
  • QA/QC staff
  • General/corporate counsel
  • Regulatory/legislative affairs professionals
Phone: toll free (888) 838-5578 (inside the U.S.) or +1 (703) 538-7600

Jill Iacopi is founder and CEO of Moonbay Technology, a software-as-a-service company providing applications for biotechnology and pharmaceutical companies.  She has over 14 years of experience in quality and regulatory affairs. In addition to founding Moonbay Technology, Jill has spent the last five years as a regulatory affairs consultant, contracting for small drug-development companies that need assistance with the tactical implementation of regulatory strategy for IND submissions. She is a member of the Drug Information Association (DIA) and Regulatory Affairs Professional Society (RAPS) and was RAC-certified for three years.  Working in quality and regulatory affairs has enabled Jill to understand the regulations and to develop software applications from a drug-development perspective.

Lee Knoch is vice president of sales and marketing at Moonbay Technology. With more than 30 years experience in the high-tech marketplace and almost five years of experience in life sciences, Lee brings extensive sales, marketing and technology experience, as well as substantial industry and eCTD knowledge, to Moonbay. Prior to Moonbay, Lee was president and CEO of a software company that provides eCTD solutions. Lee is a member of the Drug Information Association (DIA) and Regulatory Affairs Professional Society (RAPS).

Order now!