Proper document management practices are essential to the creation, assembly and maintenance of the eCTD. An Electronic Document Management System (EDMS) generally includes such features 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 to allow end-users the ability to browse, search, view and manage source documents and to electronically publish eCTDs quickly. Most often, these practices are tightly integrated with electronic publishing technology, thus providing a closed-loop system. Regulatory content management systems must also manage document content and all associated metadata (properties) to facilitate classification and searching.
The following best practices for electronic content management ensure operational efficiency and compliance.
1. Ensure your EDMS has integrated document process life cycle capability.
Most EDMS systems have built-in functionality for document process lifecycle control and work flow. It’s beneficial to your submission processes to leverage this capability, so make sure that it’s included in your content management system.
2. Ensure compliance with 21 CFR Part 11.
All regulatory content management and control systems are subject to 21 CFR Part 11 requirements. If you’re not compliant, expect delays.
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. Be sure to validate all of your EDMS systems to be sure that they meet established requirements.
4. Create a mandate for EDMS supported by top-level management.
EDMS projects rarely succeed without backing from all levels of management. If there’s no mandate in place, end-users of even the most efficient and easy-to-use systems will continue to work outside of the EDMS. Management must support the message that use of the system is not optional but mandatory. Otherwise, the left hand doesn’t know what the right hand is doing and that can result in multiple delays.
5. 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 advise that you make sure that there’s an extensible architectural framework with an open API in place to enable effective connectivity.
6. Establish effective policies and procedures upfront.
Compliance cannot be met with technology alone; it also requires effective policies and procedures. We recommend establishing and communicating clear processes and regulations to govern your content management systems. These may include:
- Systems operating procedures
- Disaster recovery procedures
- Security and access procedures
- Operational procedures
7. Develop comprehensive strategy for migration.
Migration is often an afterthought for many content management systems. These systems house thousands of critical documents. As these documents progress through their life cycles, many of them have multiple versions, attributes/metadata, electronic signatures and other process information associated with the official record. Developing a comprehensive migration strategy will ensure migration of the total electronic record.
8. Leverage integrated off-the-shelf tools for:
- Document rendering
- Document watermarking (if needed)
- Controlled printing (if needed)
- Regulatory publishing
9. Avoid over-customization.
Over-customization is the most common mistake that Life Sciences companies make when it comes to regulatory content management systems. Every company believes their organization is unique and requires custom solutions to be successful. While your organization may in fact, be unique, chances are that your EDMS doesn’t need to be. That’s why it’s best to leverage current Commercial-Off-The-Shelf (COTS) applications as much as possible. These systems have many of the core features required to successfully develop eCTDs and more often than not, customization dollars are poorly spent and have little return on investment.
10. Train all authorized users.
Training is often overlooked when deploying document management solutions so we can’t emphasize this enough: it is absolutely essential that all users have proper training. One option to consider is the use of e-Learning technologies to deliver "any time/anywhere" training and in fact, many Life Sciences companies have developed these technologies to track and manage training in accordance with cGMP requirements.
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