Guest View: Building A Transparent Enterprise

Forward looking pharmaceutical and life sciences companies are adopting an enterprise-wide strategy to consolidate document or content-centric applications, and create a holistic, centralized view of



Forward looking pharmaceutical and life sciences companies are adopting an enterprise-wide strategy to consolidate document or content-centric applications, and create a holistic, centralized view of business information across the organization. An enterprise-wide content management strategy improves information sharing across departments and supports critical processes for the compliant management of all paper and electronic records and documents.

In the past, organizations have focused heavily on the document management aspect of content management, and neglected issues such as retention, archival, workflow and reporting. An enterprise-wide strategy encompasses the entire content lifecycle from creation and approval through to retention and disposition.

In addition to the benefits of information sharing and reduced duplication of efforts, life sciences companies are recognizing the pure cost advantage of a single Enterprise Content Management (ECM) system for the housing of all business content. By deploying a single ECM platform for the management of finance and operational content, drug development documents, clinical trails and patient record information, Standard Operating Procedures (SOP), and quality control documents, companies can lower the total-cost-of-ownership of content management technology. With integrated business performance enhancement capabilities such as business process workflow, group collaboration, and intelligence reporting, organizations can automate processes on top of their content management platform.

A true enterprise approach touches on a wide range of technologies and business processes. For example, a content management system may support the following industry-specific applications:


Regulated content approval and control

Submissions content management and assembly

Quality issues tracking and corrective and preventative actions management

And learning management

And the following enterprise applications:


Records management

Contract and vendor management

SAP content archiving

Internal controls and corporate governance

Litigation support and eDiscovery

And email management

The Benefits of Enterprise Content Management

As stated earlier, organizations are choosing enterprise-wide content management strategies to improve information sharing and decision making among teams, and to address compliance requirements. To be successful, however, organizations must choose to break down silos of information, finding departments and processes that need to be incorporated into an enterprise strategy. Examples of two data and document-intensive processes that would benefit from a centralized approach to enterprise content management are quality management initiatives, and the creation and management of contracts and vendor relationships.

A typical quality management system has the following four components:

An issue and CAPA tracking system which collects the required information for the issue, the investigation and the corrective actions. The information from this process is then compiled for the required regulatory filing.

An accreditation tracking system for the housing of procedural documents and other training material, the tracking of employees who are required to and have reviewed the materials, and the reporting on completed training.

A document management system which is used to house the documents associated with the quality management process, with basic document management functionality such as version control and check-in/check-out.

An auditing function that collects information and documentation related to quality audits.

All of the basic technology functions of a quality management system are inherent in enterprise content management architecture. Document and records management, workflow, collaboration and reporting are the technologies required to support the quality process. Organizations are able to consolidate their quality management content into the rest of their organizational content using an ECM platform, brining this critical information into the enterprise fold where it can be utilized where needed in other important business processes.

The management of contracts and vendor relationships tends to reside in siloed applications that only contract managers can access, leaving out other stakeholders who need access to contract information. With an ECM-based contract management system, contracts and supporting documentation are stored in a centralized system, and not redundantly stored in a separate system for a small group of users.

Sophisticated security and document control is applied to every document, so users cannot see content they are not allowed to see. Organizations can use the workflow tools to review and approve contracts similar to the way they would approve all content, and in compliance with governance policies and industry regulations, as required. Contracts are actively managed throughout their lifecycle with key performance indicators and contract dates being tracked and acted upon by taking advantage of integrated ECM reporting capabilities. An integrated approach to contracts encourages wider collaboration and sharing of business content such as contracts.

Achieving Enterprise Transparency

When drawing up your organization's enterprise-wide content strategy, you should consider the following:

How will I unify and integrate the organization's critical business content so that I can support multiple geographies and functions? You want to include information from both structured and unstructured information systems in a seamless way so that the content can be searched, retrieved, and shared.

What can be done to eliminate information silos? Rapid evolution of technology and a response to increasing regulatory requirements has resulted in environments that contain point solutions and information silos. Some processes can be transitioned into your ECM environment, supported through robust workflows, and detailed reporting; other processes will need to be supported through integrated point solutions.

Will the content management platform grow with the organization? There are a number of points to consider when it comes to the growth of your ECM system. Your organization needs a system that can scale from a technical perspective to support more users and more applications over time, consider satellite offices and low-bandwidth connectivity in this analysis. Also, flexibility -- if applications can be readily configured and deployed, the organization can do more with the content management platform in a shorter time. Look for a system that can meet your needs through configuration, rather than customization.

How much will it cost? Do a full analysis up-front. Make sure you understand the scope of everything that needs to be accomplished with your enterprise content management system. It is not just about buying the software. If you make investments in the implementation, training and the configuration of applications in the beginning, it ends-up costing you less over the long run. The ideal system will provide you with the ability to create and modify applications without significant training and implementation costs.

Life sciences companies can take several steps to ensure they'sre on the right path to achieving enterprise transparency by leveraging existing technology solutions and content repositories, and coupling them with a next-generation enterprise content management framework. Powerful enterprise search functions, security controls to ensure appropriate access, metadata capture, secure information retrieval with process automation tools, and intuitive retrieval capabilities are all required to ensure content is available to appropriate users when they need it and in the right context..

To help companies move to an enterprise-wide content management, ECM vendors today can not only manage content stored in their own repositories, they can also manage the metadata and lifecycle of content stored in enterprise applications from software systems, content repositories, email servers, and file systems.

The emerging industry need for an enterprise content management strategy in life sciences will force pharmaceutical and life sciences organizations to more effectively leverage content and metadata investments across applications and the organization, and provide a unified view of structured and unstructured business content for significant productivity gains and better decision-making.

About the Author:
Therese Harris, Program Manager for Life Sciences at Open Text, is responsible for vertical market applications, key industry partnerships, and marketing specific to Life Sciences. She has over 15 years experience in the enterprise software industry with special focuses on collaboration, communication and compliance solutions. Therese has spent the past six years in the Enterprise Content Management market and has written and lectured on the application of ECM in vertical markets such as Life Sciences, Financial Services, and Government.