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Top Considerations for Implementing a GxP Content Management System


With the ever-increasing amount of clinical, compliance, and regulatory data, life science companies must find a content management solution that meets their business demands.

When implementing a content management system, your organization needs a platform that aligns system capabilities and streamlines functional business needs. Here are the top seven things to consider when implementing a content management system for pre-commercial companies:

1) Enterprise-wide content management system goals and objectives

When selecting a content management system, you need to consider your enterprise-wide content management system goals and objectives. Many companies pick systems they are familiar with rather than looking at the bigger picture. I often hear, “this is what we used at our old company, and it will work for us here too,” only to strip out the system a week after implementation. Look at the bigger picture and determine what your needs are. Will you have one comprehensive enterprise-wide content management system, or are you looking at various point solutions (business fit for purpose)? Point solutions can house specific types of content with metadata, taxonomy, and structure built around a particular workflow. In contrast, an enterprise-wide content management system supports key organizational processes through its entire lifecycle. Be sure the type of system you choose meets your goals and objectives.

2) Cloud or On-Prem

Depending on your business strategy, you will decide between a cloud or on-premises content management solution. We have seen a significant shift from on-premises systems that were enterprise-wide to cloud-based systems. There has been a considerable change in the functionality of these technologies, the various types of content inputs, and how they are structured. On-premises content management solutions require internal management and implementation versus a cloud solution that is typically implemented and managed by the SaaS company. On-premises solutions often take more time to implement due to the extensive planning required, whereas a cloud solution is almost always immediately available through the cloud provider. While there is no right or wrong answer, at USDM, we see that most of our emerging customers go with a cloud-first approach.

3) IT Roadmap

An IT Roadmap is a roadmap of prioritized recommendations based on the current state of business needs and expectations of what will be in place at upcoming milestones on the journey to regulatory readiness and commercialization, and beyond. Defining what your overall IT roadmap is, and how future technology solutions will integrate with your content management system is critical to the planning and development of an emerging life science company.  It is essential to look at your overall goals and have a comprehensive IT strategy and roadmap of where you are going, what you need to accomplish, and the timeframes for specific milestones across the organization.

4) User Requirements

It is imperative to define a comprehensive set of user requirements for the types of content across the various business units that you are going to be implementing a content management system for. You will need to understand what type of content that is. For example, are you going to be storing eTMF, eCTD, contracts, SOPs, and many other types of content? Do you need workflows? If so, what are the types of workflows (i.e., GxP and non-GxP)? Do you need audit trails? Do you need eSignatures? On the flip side, if you will not be routing the data for eSignature, you won’t need that capability. It also helps to compare needs across all the users by creating a user matrix. If you have three different business stakeholders in various business units (regulatory, clinical, and lab), for example, you will need to have them assess the technology as they go through vendor demos. Once the user requirements are defined, you will want to engage with the business units for an organized approach to the vendor selection process.

5) Vendor Selection

It is not always apples to apples when comparing one system to another. It is important to pull all the key stakeholders together to refine and document the user requirements, and then do an assessment of the technologies available that meet your needs. Develop your solution strategy, and look at your critical use cases, ensure the systems align with your business requirements. When comparing vendor pricing, look closely at the total service offering. Some vendors will provide a comprehensive suite with extended support, while others may only implement the system. Also, consider if they have life sciences and GxP experience. With the FDA’s new Computer Software Assurance guidance coming out, you will be able to leverage the vendor’s assurance activities to minimize your regulatory burdens assuming the vendor has a mature and transparent SDLC process.  Bottom line – do not overlook the long-term costs of implementing a short-sighted, lower price solution.

6) Communications and Training

Planning for communications and training is crucial, especially if you are going with an enterprise-wide system. You will not recapture your ROI or have adherence to the business processes if you don’t have a comprehensive plan for training and communication. When implementing a system that will impact the entire organization, it’s essential to have a detailed training and communications plan that explains the who, what, why, and how. You’ll need to show and tell what is in it for the end-user, as they go through learning the new system. I have seen many companies implement an SOP management system, and when we go on-site for an assessment, we find that most people have hard paper copies of the SOPs on their desktop because they don’t know how to use the system to find the SOPs they need. This is not only a potentially huge compliance issue, but it is also money down the drain for these companies.

7) System Management

To develop all the required validation documentation, you will need to appoint someone to manage the validation process at the start of the project. This will include program management, validation management, and then managing the technical cloud vendor and organizational change management. You will need to plan for the future, including the validation and support of the system. How will you manage the changes in the cloud? Are there changes on a daily, weekly, or monthly basis? There is an inherent cost to managing these changes in a regulated environment from the validation side. You will want an IT program manager in your organization that can help you truly implement the technology. Typically, somebody who has done it before, who understands that technology and can help to guide implementation cohesively across your organization. It helps to have an IT program manager that understands business process flow in the regulated space. Many of our startup customers hire USDM to come in and run these things because they only have one or two IT people in-house. The technology provider typically provides a technical project manager, but they are only concerned with how to set up the system, not how to manage the system once it’s setup.

With more than 400 emerging customers served, USDM has the experience and regulatory domain knowledge to help you select the right content management vendor or assist you on your journey to commercialization.


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