Learning Management - Tied Together with CAPAs and SOP management

I have been asked a lot lately about how learning management can be more closely tied to quality management and an organization’s electronic document management system (EDMS). From a process standpoint, these two are already very closely related; but from a technology standpoint, many organizations are still running these two systems separately. As a content management vendor, I can see how learning management systems need to be closely tied to the content and procedures that employees are trained on. Additionally, content about the training; histories, certificates, and the like need to be stored and tied to each employee’s training record.

By implementing a learning management system with quality and SOP management applications, organizations can ensure that training data and content is tied together. Training is often an identified area of concern during a regulatory audit, so every organization should have an electronic learning management system closely tied to an EDMS, as well as other business information.

Report on the DIA 45th Annual Meeting - An eye for safety and quality

So ends another DIA Annual Meeting. This years event was really great, with lots of energy, and many chances to learn and network.

The theme of this year's meeting was "Better Medicines: Improving Safety with Every Step". By the buzz on the show floor safety and quality is on everyone mind.

More and more organizations are looking to enable, or better enable their companies quality management program, in today's world that typically means applying technology to tasks that are currently performed manually. Quality management systems have their place, but when combined with your enterprise systems, such as document management and ERP systems, the power is amplified. This integration, or combination allows information workers to see a more complete picture of the content and data they need to identify, analyse and resolve quality issues.

Documents are an integral part of the quality management process, and items such as reports and remediation plans need to be linked to (or stored with) the data that corresponds to CAPAs, deviaitons and audit findings. A holistic view of the quality management programs enables organizations to offer better safety and quality to the end consumer.

Better Together

Traditionally, ECM only touched a relatively small user community, and applications in this world were highly specific to a critical business process. But Microsoft has changed the ECM world by offering core content management capability to all users in an organization through their desktop environment. This dramatically increases the amount of content under management and replaces file systems over time. It is clear that through the Microsoft infrastructure a much more systematic approach to managing all unstructured content in an organization becomes possible.

Microsoft SharePoint adoption is an increasing trend in most industries and Pharmaceuticals and Biotechnology is no exception. What was a very early-adopter trend two years ago with large pharmaceuticals like Pfizer and Eli Lilly is now becoming mainstream. Most organizations have, or plan to have some element of SharePoint within their overall ECM infrastructure. A common question for most companies is “How will SharePoint and my EDMS work together?”

Today’s mainstream ECM vendors provide customers with both infrastructure enhancements to the Microsoft stack as well as business solutions that run on top of the infrastructure. Organizations will continue to look to SharePoint as a user friendly end user interface that can help to rollout the ECM infrastructure and applications to other parts of the organization.

The Evolution of Publishing and Regulatory Submissions

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.

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.

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.

The Evolution of Electronic Document Management Systems in Life Sciences – Part 2

The evolution document management has lead to an enterprise-wide strategy which encompasses the entire content life cycle from creation and approval through to retention and disposition.

Employing an enterprise strategy is something that many organizations desire, but few have achieved. As the concept evolves over the next 3-5 years, organizations will need to consider the following:

· How can they unify and integrate the organization’s critical business content so that they can support multiple geographies and functions? Organizations will want to include information from both structured and unstructured information systems in a seamless way so that the content can be searched, retrieved, and shared.

· What can be done to eliminate information silos? Rapid evolution of technology and a response to increasing regulatory requirements has resulted in environments that contain point solutions and information silos. Some processes can be transitioned into an ECM environment, and supported through robust workflows and detailed reporting; other processes will need to be supported through integrated point solutions.

· Will the content management platform grow with the organization? There are a number of points to consider when it comes to the growth of an ECM system. Organizations need a system that can scale from a technical perspective to support more users and more applications over time, and should consider satellite offices and low-bandwidth connectivity in this analysis. Also, flexibility -- if applications can be readily configured and deployed, the organization can do more with the content management platform in a shorter time. Organizations should look for a system that can meet their needs through configuration, rather than customization.

· How much will it cost? Organizations need to do a full analysis up-front taking into account their enterprise strategy for content over the next several years and ensure they understand the scope of everything that needs to be accomplished with their enterprise content management system. It is not just about buying the software. Organizations who make investments in the implementation, training and the configuration of applications in the beginning, end-up spending less over the long run. The ideal system should provide the organization with the ability to create and modify applications without significant training and implementation costs.

Pharmaceutical companies are taking steps to ensure they’re on the right path to an enterprise architecture by leveraging existing technology solutions and content repositories, and coupling them with a next-generation enterprise content management framework. Powerful enterprise search functions, security controls to ensure appropriate access, metadata capture, secure information retrieval with process automation tools, and intuitive retrieval capabilities are all required to ensure content is available to appropriate users when they need it and in the context of how they are working with that content.

The emerging industry need for an enterprise content management strategy in life sciences will force Pharmaceutical organizations to more effectively leverage content and metadata investments across applications and the organization, and provide a unified view of structured and unstructured business content for significant productivity gains and better decision-making.