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.