Yesterday, along with FDA News, I hosted a webcast entitled, "Traditional Approaches for Collaborating With Outsourced Manufacturers and Suppliers Are Failing." As the event drew to a close, we received an influx of questions from attendees, some of which we couldn't answer due to time constraints. In this post we'll answer the top questions we were asked.
For those who were unable to attend the webcast, here's a high-level summary. With support from our research of industry best practices and data from our Quality Management survey, the overall focus of the webcast was on strategies for improving collaboration with suppliers and contract manufacturers in life sciences industries through streamlined business processes and supporting software technology. I drilled down into topics such as:
- Improving quality and compliance through collaboration with suppliers in the R&D process
- The importance of closed-loop quality management processes in increasing manufacturing efficiency
- Top trends in document management and its role in facilitating effective quality management processes and supplier collaboration
- Improving manufacturing performance by making quality an executive priority
Questions & Answers
As I mentioned, there were a number of great questions asked, and we'll get into those now. For any additional questions, feel free to leave them in the comments section below.
Q: Does Document Management really address quality processes? Or is it just paper on glass?
A: Document management is far more than paper on glass. Yes it supports quality processes, and, specifically, the type of document management software we talked about in the webinar is focused on building compliance and quality into workflows for regulated industries. This is separate from more general enterprise content management software, where it may be used for simply creating and storing documents.
Of course, in our view of Enterprise Quality Management Software, it is important that document management capabilities are tightly integrated with automated processes like CAPA, audit management, training and more.
Q: At what point does something like DropBox or Microsoft SharePoint become insufficient for document management?
A: As I said in the webinar, DropBox has a long way to go before LNS would recommend using it for handling collaboration for quality- and compliance-related content in life sciences, and, at this point, it's unclear if this is even a direction the company would like to pursue in the future. The solution is really not made for that.
SharePoint is a strong solution for enterprise content management, but, again, by itself it's not purpose-built for quality and compliance content in regulated industries. The document management solutions providers with technology built for life sciences should be thought of in a different light. Some of these use SharePoint as a platform, others use different platforms or have built their own.
With advancements to cloud-based technology and SaaS pricing models, the investment is far less risky, the implementation time shorter, and it can be more cost-effective, to use these third party type providers.
Q: What has been your experience with leveraging PLM applications to also integrate EQMS activities within the platform to improve quality efforts?
A: More and more companies are taking note of quality's impact not just in the manufacturing environment, but really across the value chain. The earlier you can catch a quality non-conformance, the less of an impact it will have (or potentially have) in the long run.
Things like design for quality and design for manufacturability are gaining ground, and in that respect we're seeing increased focus on the integration of EQMS and PLM or in some cases using PLM to deliver EQMS functionality, including document management. We expect this trend to pick up steam in the coming years but there are still vast differences between the various PLM vendors when it comes to quality capabilities and the majority of companies are still looking toward more purpose-built and focused vendors on quality and compliance for life sciences.
The important thing is for your company to have a future vision and realistic understanding of current capabilities, and then map vendors to these gaps.
Q: What's the connection between document management and Enterprise Quality Management Software?
A: In the LNS Research definition of Enterprise Quality Management Software, document management is a critical component of the overall solution. It is also important that document management is integrated with EQMS processes like NC/CAPA, audit management, training, and more.
For some life sciences companies, EQMS functionality is delivered by multiple vendors that may specialize in different areas. For example, one vendor may be a specialist in NC/CAPA and another a specialist in document management. In other cases, life sciences companies may use a single vendor to manage both documents and processes.
Q: When working to harmonize processes between pharma and partners/suppliers, is there a starting point you would recommend? Where can companies get their first win?
A: I always recommend starting in a place that sets your organization up for success. In many cases this means focusing on collaboration around documents with your most strategic suppliers. Over time, this can be extended to more suppliers and can also be extended to more complex processes, like engineering change orders, real-time process visibility, supplier corrective actions, and audit management.
Q: Are you seeing different approaches between small and large companies?
A: Yes there are differences. Smaller companies typically are replacing purely homegrown paper-based systems where larger companies are often trying to harmonize multiple commercial legacy systems. There are also differences in IT resources, smaller companies generally have limited IT resources with little experience in quality systems. Larger life sciences companies likely have many IT resources, often with quality systems experience, but new projects like this can often get pushed down the list of priorities.
Interestingly, even though the companies come from different spots, in many cases next-generation EQMS can help.
Q: Can a system like this help in terms of knowledge retention and the impending exit of Baby Boomers from the workforce?
A: We see many companies leveraging document management software for training purposes, as well as for capturing things like best practices and SOPs. We'll be covering the topic of the aging workforce in manufacturing more in depth in the near future, but, yes, this type of solution can help with that transition.
Knowledge flight is a very real threat and it needs to be dealt with systematically. Document management solutions can provide a central, secure platform for such information capture.
There is also a flip side to this coin. The systems that are used to capture data also have to be easy to use for the upcoming generation. This means being consumer grade when it comes to search, social, and analytics. Younger employees won't tolerate enterprise systems that don't meet the same standards that Google, Amazon, or LinkedIn achieve.
Q: Are you seeing any pushback from regulatory agencies on the solutions companies are using?
A: Not generally. Most document management solutions providers--especially the ones focused on delivering purpose-built solutions for life sciences--spend considerable resources on making sure things like streamlined FDA submissions are executed in alignment with current and emerging regulations. The cloud-based solutions also go through numerous levels of validation to ensure security.
Q: From the FDA's perspective, are there privacy concerns in terms of using these types of solutions?
A: Privacy and security concerns come out as some of the top concerns for cloud-based solutions in our surveys. Although the comfort level is not yet there for many companies when it comes to security and privacy in the cloud, for most companies this is a fear of the unknown rather than grounded in facts.
It is important moving forward that companies don't over estimate the security of what currently exists in homegrown or on-premise solutions nor underestimate the gains cloud-based companies have made over the years with their own security.
For those of you that missed the webcast, you can access a full recording of the event by clicking below.