Editor’s Note: This entry was written by Kathie Clark, former Director of Professional Services at GlobalSubmit. Kathie is now Vice President, Product Management at Wingspan Technology.
Most Tier I and Tier II sponsors maintain their submission documents in an electronic document management system (EDMS). It’s obvious that software that creates electronic (or paper) submissions must work with the documents managed in the EDMS. But what is not so obvious is the optimal integration between an EDMS and a publishing tool.
Approach 1: A Single Product – EDMS/Publishing System
At one end of the spectrum are a few systems where the EDMS and publishing system is actually the same product. There are certainly advantages to this approach – one vendor, claims of no incompatibilities between systems, and a common approach to the user interface and business rules. However, there are many drawbacks as well. Tight coupling of the systems means a significant impact on validation of the EDMS component whenever the validation component needs to change to install upgrades or reflect new agency guidance – and vice versa. There are also the complaints that these systems are really optimized for EDMS, and that submission assembly, let alone review and QC, are an afterthought at best. Finally, you are very tied into a specific technology. For example, a migration from a Documentum EDMS to SharePoint would probably require the wholesale replacement of your publishing tool as well as EDMS.
Approach 2: Simple Interface – Export Documents from EDMS into Publishing Tool
At the other end would be a very simple interface – not even an integration – where you export documents from your EDMS and import them into the publishing tool. This is straightforward, but you lose the ability to use EDMS metadata (such as title) and to keep track of document updates and versioning.
Approach 3: Publishing Systems with Specific Interface Points
Somewhere in the middle are those publishing systems that can provide specific interface points, generally by using the APIs or web services provided by EDMS platforms. The value of developing and validating software to automate a process that’s usually only performed a few times a year (creating a new application) is questionable, especially when it may require an update whenever a regional authority issues a new Module 1 specification.
So what are the essential elements of EDMS integration? Here is a draft high-level list to start, but please feel free to share other thoughts and ideas:
- Ability to navigate the folder structure of the EDMS to locate documents (if it has one – SharePoint MOSS does not)
• Ability to search the EDMS using document content and properties
• Ability to “bind” to a specific version of a document (for example V2.0 of a specification) – or potentially a status/version label such as “Approved”
• Alert that a newer version of a document is available so the publisher can determine if it should be used, and update to the newer version with one click if desired
• Transfer of a (configurable) EDMS property into the eCTD title
• Ability to handle XML documents (such as SPL and define.xml) properly
• Control over which rendition is to be used (almost always PDF, but there are rare exceptions)
Some “nice to have” features:
- Ability to source lists in the publishing tool (such as dosage form or manufacturer) from corresponding lists in the EDMS
• Auto-suggestion of what documents might be included in each eCTD section (e.g., locate potential QOS documents for a specific product when populating 2.3, based on their EDMS properties)
• Archiving of a completed eCTD back into the EDMS for records management purposes
• “Where used” function – based on an EDMS ID, report on the list of applications and sequences in which a document (or document version) has been used.
One more point – when should the file transfer occur between the EDMS and the final publishing area? My thoughts are that files should be transferred when they are added to a submission TOC, to minimize the time needed after the “publish button” is pushed, and to allow the creation of inter-document hyperlinks, which can rarely be created in the EDMS. However, a check needs to be made for documents that have been updated since transfer at the time of final QC and publish. Does the way a file transfer is handled need to be configurable?