ECTD Content Management
Proper document management practices are essential to the creation, assembly, and maintenance of an eCTD. An Electronic Document Management System (EDMS) generally includes features such as check-in/check-out, version control, and audit trails. EDMS also boasts document-level security for all kinds of document file types including word processing documents, XML, images, and much more.
To establish compliance, documents related to eCTD submissions must be easily accessible. Regulatory content management systems must also manage document content and all associated metadata (properties) to facilitate classification and searching. This availability allows end users to browse, search, view and manage source documents, and to electronically publish eCTDs quickly. Most often, these systems are tightly integrated with electronic publishing technology, providing a closed-loop system.
The following best practices for electronic content management ensure operational efficiency and compliance:
1. EDMS with Integrated Document Process Lifecycle Capability
The majority of EDMS systems have built-in functionality to control document process lifecycle and workflow.
2. Ensure Compliance with 21 CFR Part 11
All regulatory content management and control systems are subject to 21 CFR Part 11 requirements. Non-compliance will result in increased risk and possible delay.
3. Validate All EDMS Systems
It’s necessary to establish user requirements for your system so that all validation activities can be completed and documented in accordance with intended use. Validate all aspects of your EDMS systems to be certain that they meet established requirements.
4. Buy-in for EDMS from Top-Level Management
EDMS projects rarely succeed without support from primary decision makers. If there isn’t a mandate in place, users of even the most efficient, streamlined systems will continue to operate outside of the EDMS. Management must convey that use of EDMS is mandatory, not optional. Otherwise, your organization will suffer from a lack of common purpose and transparency, making delays inevitable.
5. Avoid Excessive Customization
A common trap life science organizations fall into when it comes to regulatory content management systems is unnecessary customization. Every company insists it is unique and requires a fully-customized solution to be successful. While your organization does have its own unique qualities, standard EDMS systems have many of the core features needed to successfully develop eCTDs. More often than not, customization dollars are poorly spent and have little return on investment. The best strategy is to install a proven EDMS and make limited changes to default settings that provide obvious benefits to your organization.
6. Look for Extensible Architectural Framework
Regulatory content management systems must operate in an integrated systems environment. Most systems require connectivity to existing legacy systems (such as clinical trials or clinical data management systems). Current best practices strongly recommend an extensible architectural framework with an open API in place to enable effective connectivity.
7. Proactive Establishment of Policies and Procedures
Compliance cannot be achieved with technology alone. Effective policies and procedures are vital. We recommend establishing and communicating defined processes and regulations to govern your content management systems. These may include:
- Systems operating procedures
- Disaster recovery procedures
- Security and access procedures
- Operational procedures
8. Develop a Comprehensive Migration Strategy
Migration is often an afterthought when instituting a content management system. Over time documents move through lifecycles with multiple versions, attributes/metadata, electronic signatures, and other process information associated with the official record. Developing a comprehensive strategy will ensure migration of the total electronic record.
Note: This strategy is only applicable to organizations switching DMS systems
9. Leverage Integrated Off-the-Shelf Tools
- Document rendering
- Document watermarking (if needed)
- Controlled printing (if needed)
- Regulatory publishing
10. Train All Authorized Users
Training is sometimes glossed over when deploying document management solutions. This is a mistake. It is absolutely essential that all users receive proper training. One option is remote, web-based training that can be completed at a user’s convenience and managed in accordance with cGMP requirements.
11. Consider the Cloud
The modern workforce is mobile. To encourage collaboration amongst co-workers, your content should be available in a single destination. A cloud-based document management system allows for the synchronization of documents throughout a submission lifecycle and easier archival procedures. This way, users will have confidence that they’re working on updated versions of documents. Security is a legitimate concern, but popular cloud solutions such as Amazon Web Services (AWS) have been granted clearance from a host of federal agencies, including the US FDA. Compared to traditional enterprise document management systems tied to a physical location, cloud-based deployments aren’t subject to high costs or complex implementation cycles.