Enterprise content management systems
Content lifecycle management includes check-in/check-out, version control, audit trails and document-level security for all kinds of document file types, including word processing documents, Web pages, images, and more.
Compliance Challenges
As part of any compliance initiative, information must be easily accessible so end users can browse, search, manage tasks and view content as well as electronic documents quickly. These systems must also manage document content and all associated metadata (properties) that further describes the document to facilitate content-based searches. Regulated companies often store information in a structured way, enhance information retrieval by intranet, extranet or Website and automatically find and index new or modified documents.
Compliance process management systems combine content archival and retrieval functionality with process workflow in order to facilitate the management of complex processes across departments and delivery channels. Document workflows are designed to capture documents at the earliest possible point in a business process, thus eliminating the movement of paper throughout the geographical between locations. Amadeus’ eQCM Electronic Document Management software allows business processes to be automated, linking all tasks together in a logical sequence with electronic documents attached. In order to take full advantage of document management, systems should be integrated with other enterprise technologies.
Enterprise Content Management Best Practices
Increased operational efficiencies can be achieved by the comprehensive management of all electronic documents. Any documents that are a part of a version/revision lifecycle are maintained for each iteration electronically, securely stored for future management or rollback. They are available for sharing and group collaboration based on specified employee security levels. Once documents are available in electronic form, they can be instantly viewed by anyone through the document management system, a Web browser, or any other integrated application system.
The following best practices for electronic content management ensure operational efficiency and compliance.
- Ensure your ECM has integrated document process lifecycle
capability. Most ECM systems designed for
regulatory compliance include built-in functionality for document
process lifecycle control. It is current best practice
to leverage this capability and ensure its inclusion in your
content management system.
- Built-in compliance with 21 CFR Part 11. It is current best practice to ensure that all regulatory content management and control systems are in compliance with 21 CFR Part 11 closed system requirements.
- Validate all ECM systems. It is current
best practice to review predicate rule requirements that govern
the type of documents stored within the ECM and validate the
system accordingly. It is important to establish a set
of user requirements for the system so that all validation activities
can be performed in accordance with intended use.
- Establish ubiquitous Web portal interface to ensure
rapid adoption. To ensure rapid system adoption,
it is current best practice to design the system using a ubiquitous
Web portal interface. The global familiarity with Web
technology will ensure that users adopt the system for its
intended use.
- Adapt extensible architectural framework. Regulatory
content management systems must operate in an integrated systems
environment. Most systems require connectivity to existing
legacy systems such as MRP, ERP and other quality management
systems. It is current best practice to ensure an extensible
architectural framework with an open API to enable effective
connectivity.
- Establish effective policies and procedures upfront. Compliance
cannot be met with technology alone. It requires effective policies and procedures to ensure compliance. It
is recommended best practice to establish and communicate
clear policies and procedures for governance of content management
systems. These may include:
- Systems operating procedures
- Disaster recovery procedures
- Security and access procedures
- Operational procedures
- Develop comprehensive strategy for migration. Migration
is often an afterthought for many content management systems. These
system house thousands of mission-critical documents. As
these documents progress through their lifecycles, many of them
have multiple versions, attributes/metadata, electronic signatures
and other process information associated with the official record. It
is best practice to develop a comprehensive migration strategy
to ensure migration of the total electronic record.
- Use federated systems approach for global/large deployments.
- Define cabinet/folder hierarchy prior to deployment.
- Establish security/access policies and procedures
up front.
- Leverage integrated off-the-shelf tools for:
- Document rendering
- Document watermarking
- Controlled printing
- Regulatory publishing
- Avoid over-customization.
- Train all authorized users
