This is an updated Blog from a previous post which can be found at http://www.opentext.com/blogs/ecm_briefs/2009/02/a_year_later_evaluating_electr.html.
As with most compliance solutions, companies will put whatever is needed in place to meet the requirements, and come back and re-evaluate their decisions later. On January 1, 2008 the FDA withdrew guidance for non-electronic common technical document (eCTD) submissions, and to prepare for that, along with various other regional requirements, pharmaceutical companies implemented multiple solutions to address their varying requirements.
In early 2008 organizations were talking to me about preparing electronic submissions, and seeking the assistance of the technology vendors to help them get organized for this upcoming event. Although some had already chosen a tool, some were still looking, and most were still trying to find out more about what was available, whether they had purchased a tool or not.
To find out more about my views of eCTD Submissions and technology tools listen to this Podcast - Electronic Submissions - Pharmaceutical and Life Sciences Industry featuring Therese Harris, Program Manager for Life Sciences at Open Text and Harv Martens from the ICH M2 Working Committee.
Fast-forward to 2009, and the mood is different. A large number of companies are now looking to standardize on an eCTD submissions tool. The problem, as explained by a number of pharmaceutical companies, is that they cannot get it all from a single tool. They know what they need to do, and now they want to do it.
But this market is maturing from a technology adoption perspective; it is no longer the early adopter market that it once was. It is mainstream -- the early majority, according to Geoffrey Moore's Crossing the Chasm. This is the time when the superior products rise to the top, and others will struggle and drop-out of the market.
Electronic submission technology is at the point when pharmaceutical companies can expect to get what they require, without have to use multiple technologies for varying requirements. And although vendors need to rapidly develop their solutions to meet new and changing requirements from the various regulatory bodies, companies should expect a stronger focus on usability over the next 12 to 24 months.
Friday, May 22, 2009
Friday, May 15, 2009
The Role of the EDMS in the Regulatory Submissions Process
As someone who works for a vendor who is heavily focused on enterprise content management and who has significantly increased its market share in Life Sciences over the past 5 years, I am keenly aware of the increasing importance of tight integration between eCTD tools and the document management repository. Pharmaceutical and Biotechnology organizations are no longer satisfied with passive integrations between the technologies, and are driving vendors to make significant enhancements to the ways the two systems work together.
In addition, the requirements for eCTD submissions are being driven back into document management systems; document preparation, assembly and quality control are functions that need to be supported within the EDMS. A high-level of granularity, document cross-referencing, and parent-child relationships, although important in the past, have increasing value in the preparation of electronic submissions. And issues like submission sequence archiving are now a standard expectation for any EDMS.
As electronic submissions requirements evolve so will technologies that support them. I expect to see a strong importance placed on the EDMS in the preparation of “submission-ready” documents and greater cooperation between eCTD and ECM vendors over the next 3-5 years.
In addition, the requirements for eCTD submissions are being driven back into document management systems; document preparation, assembly and quality control are functions that need to be supported within the EDMS. A high-level of granularity, document cross-referencing, and parent-child relationships, although important in the past, have increasing value in the preparation of electronic submissions. And issues like submission sequence archiving are now a standard expectation for any EDMS.
As electronic submissions requirements evolve so will technologies that support them. I expect to see a strong importance placed on the EDMS in the preparation of “submission-ready” documents and greater cooperation between eCTD and ECM vendors over the next 3-5 years.
Tuesday, May 5, 2009
Creating A Content Journey for Your Pharmaceutical Company
Each organizations strategic content management journey will be different; however as it is possible to plot a number of typical journeys for companies in the pharmaceutical industry. Let me illustrate a journey which begins with regulatory submissions and controlled content. This journey begins with the adoption of an electronic document management system to address 21 CFR Part 11 requirements for the electronic signature and electronic management of records. As the adoption of the document management system increases from strictly controlled document processes to non-controlled content, organizations begin to use their ECM platform for improved business processes through workflow, increasing content collaboration and information sharing through-out the organization.
With the increased use of electronic documents versus paper documents, there becomes an increased risk associated with the management of corporate records. What may have been a departmental strategy for records management of controlled content must now become an enterprise program for the appropriate retention, storage and disposition of records. As the records management strategy of any organization evolves additional forms of media are encompassed within that strategy, these include; content from other document management systems, documents and data from structured data sources such as ERP and CRM systems, email and other electronic communication content, web and social networking content, and digital assets and marketing media.
An enterprise approach to content reflects the evolution of content management from simply tracking and controlling information to leveraging it for business advantage – setting it in action to drive business processes, create content-centric business applications, bridge structured and unstructured content repositories, and unleash information workers to make better, faster decisions based on a holistic, centralized view of business content.
The enterprise content management suite assists organizations in establishing an enterprise strategy for content centric applications. Industry specific applications for life sciences must be part of the suite and should include regulatory content and submissions, quality management, and clinical trials. Other business related applications supported by the suite could include; contract management, litigation support, email management, records management, Web content management, and ERP / CRM archiving. Organizations in the life sciences industry deal with millions of documents, and hundreds of millions of pages of information; ECM gives these organizations the ability to gather, process, and manage these documents more effectively.
With the increased use of electronic documents versus paper documents, there becomes an increased risk associated with the management of corporate records. What may have been a departmental strategy for records management of controlled content must now become an enterprise program for the appropriate retention, storage and disposition of records. As the records management strategy of any organization evolves additional forms of media are encompassed within that strategy, these include; content from other document management systems, documents and data from structured data sources such as ERP and CRM systems, email and other electronic communication content, web and social networking content, and digital assets and marketing media.
An enterprise approach to content reflects the evolution of content management from simply tracking and controlling information to leveraging it for business advantage – setting it in action to drive business processes, create content-centric business applications, bridge structured and unstructured content repositories, and unleash information workers to make better, faster decisions based on a holistic, centralized view of business content.
The enterprise content management suite assists organizations in establishing an enterprise strategy for content centric applications. Industry specific applications for life sciences must be part of the suite and should include regulatory content and submissions, quality management, and clinical trials. Other business related applications supported by the suite could include; contract management, litigation support, email management, records management, Web content management, and ERP / CRM archiving. Organizations in the life sciences industry deal with millions of documents, and hundreds of millions of pages of information; ECM gives these organizations the ability to gather, process, and manage these documents more effectively.
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