Biotechnology firms, as well as smaller pharmaceutical companies, face many of the same regulatory and technology challenges of large pharma, often without the budgets to match. It is critical that these companies carefully identify and implement technology solutions that both satisfy regulatory requirements and enable them to bring products to market sooner. The following article discusses the business benefits of an electronic content management solution and provides an approach for implementation in mid-tier, cost-conscious life science organizations.

The Corporate Environment
The environment at most biotechs and start-up pharmaceutical firms differs significantly from that of large pharmaceutical companies. Smaller companies tend to rely on external providers for a much larger percentage of the workload. Working on tight budget constraints, the IT departments of these organizations are typically made up of one person, often a “jack-of-all-trades” with little application-specific expertise. Additionally, given the large amount of time and financial resources required to implement, validate and support new systems, most of the firm’s data is stored in homegrown spreadsheets and databases.

On the other hand, these smaller organizations do bear some resemblance to their larger counterparts. They must adhere to the same FDA requirements that all electronic data required by GxP predicate rules must be Part 11 compliant. To that end, they must validate their applications, qualify their suppliers, and have SOPs in place. Additionally, they are driven by the same fundamental business objectives and therefore must manage the same categories of content (e.g., SOPs, submissions, web site content).

Compliance Benefits of a Content Management System
Content management systems can facilitate compliance in several ways. They make it easier for companies to establish uniform document formats and standards by providing a controlled repository for templates and mandating the use of those templates where appropriate. Version management features and granular file permissions can more tightly control access to critical content. Additionally, documents are locked during the editing process, precluding anyone except the author from making changes. Part 11 is also addressed, as these systems usually contain integrated security, audit trail and record retention features. Furthermore, these systems ensure that the appropriate people participate in document review and approval processes by requiring users to initiate a standard workflow for each regulated document type.

Perhaps the greatest benefit of content management systems is that they allow companies to establish one official repository for their controlled documents, thus eliminating the costs associated with distributing and retrieving paper copies. Having one repository also ensures that everyone uses the latest, approved version and makes it easier to share information across organizational and geographical boundaries. This single repository allows manufacturing and document control departments to manage enterprise-wide documentation processes for SOPs, corrective actions and validation documents critical to compliance. Such systems can also be used for fixed content such as electronic batch records and reports from Enterprise Resource Planning (ERP) systems.

Improving Productivity and Reducing Time-to-Market
Enhanced productivity is only part of the rationale behind implementing content management systems. The main focus of most implementations is to increase efficiency and reduce cost. Using standardized templates and consistent review processes enables faster submission preparation, leading to faster agency review particularly when the final document is submitted electronically. Additionally, submission preparation times can be further reduced by leveraging this technology to begin the authoring process sooner, improve collaboration across global sites, leverage external partners where applicable, and complete more tasks simultaneously. These systems can also accommodate the formatting and layout requirements of the new Common Technical Document, which makes it easier for small firms to submit electronically in a global regulatory environment.

Content management systems are also beneficial in sales and marketing, where they can be used to disseminate product information more quickly to end-users and physicians, often through the use of specialized web sites. Authoring tools place content creation in the hands of those who have the knowledge, thereby eliminating the bottlenecks caused by the old system of funneling all content updates through the “web master.” Essentially, these tools separate the content (text and images) from the presentation or layout of the web page, while auditing and version management features secure and track this highly regulated documentation to comply with governmental requirements.

Knowledge management initiatives can also be implemented by leveraging the robust searching and collaboration functionality of content management systems to allow organizations to gain more accurate competitive intelligence, more quickly make decisions during the discovery process, more easily capture information from experienced employees, and more rapidly disseminate business-critical information across the organization. Additionally, since external partners and service providers are an integral part of the life sciences industry, content management systems provide tools to extend workflow capabilities outside organizational boundaries via enhanced security for attached files and E-mail integration.

Implementing a CMS
No technology alone can address all productivity and compliance issues. Content management represents the intersection of people, process and content. Without taking all of these into consideration, the project will not satisfy its lofty goals of improved productivity and compliance. For a successful implementation of a content management system, companies must take time to evaluate their business processes and look for opportunities to remove tasks that do not add value. Before embarking on a content management initiative, consider the following steps:

1. Identify the players: This is the most critical aspect of any implementation initiative. Who will comprise the project’s core team and what roles will each of them
fulfill? Who will be the project sponsor? If this is an enterprise-wide initiative, you should involve representatives from each business area in the implementation.

2. Clearly define roles and responsibilities: The commitment and input of project team members are critical to the success of a content management initiative. They need to have ownership of deliverables and accountability for achieving project objectives. Additionally, team members must actively participate in process optimization workshops, requirements gathering, software demonstrations and validation testing.

3. Clearly define scope: Keep your project simple and manageable. Identify the business processes and types of files to be managed by the system and then prioritize them based on corporate goals. Which process will yield the greatest payoff if implemented within a content management system? If compliance is your main concern, determine where your greatest risks lie. Avoid over-analyzing and instead focus on achieving small goals during short intervals. If you try to take on too much or spend too much time trying to get everything perfect, you will lose the support of
management and, eventually, funding.

4. Prioritize features and functions: It is important to develop general requirements for your content management system. Take into consideration all the types of files and processes. Decide what basic features you need (e.g., audit trail, version management, searching) and prioritize them. Include corporate IT standards and Part 11 requirements, and think about what you will need from the vendor. Survey available products and select the one that best meets your needs and fits your budget.
If you are operating with a limited budget, prioritizing the features you need is an especially important activity. You may have to give up a few “nice to haves” to keep the price acceptable. While product prices vary greatly, added functionality quickly adds to the price. Recognize that you may not be able to afford workflow capabilities or other bells and whistles until more funding is available. The challenge will be finding a low-cost solution that includes an audit trail and the other functionality required to comply with Part 11.

Look for configurable solutions that make costly customizations virtually unnecessary. Additionally, the more customizations you have, the more difficult your upgrades will be. You should also avoid the temptation to build the system from scratch. Developing a robust, compliant system will end up costing more in the long run than a configurable off-the-shelf application.

5. Evaluate your process: Optimize your highest priority business process by documenting the current state and revising it to reflect the desired future state. Identify and remove bottlenecks and eliminate steps that do not add value, such as non-required signatures. Take advantage of the technology available in the new system, including automated workflow. Remember that some tasks that are required in a paper world are no longer necessary in an electronic one.

6. Initial Rollout: It often makes sense to set the creation of a simple repository as the goal for the initial rollout. Set up the folder structure and permissions, build
templates, and require their use. As too many manda-tory properties will add time to the process, only set up document properties required to facilitate searching. Additionally, since most products come with full text indexing features, properties should not be necessary, as users can search the content of the documents.

From a process perspective, one option during this phase is to optimize the remaining processes and implement them in the basic repository. The benefit
of taking this approach is that the entire organization will be online with the new system. An alternative approach is to forge ahead with each business process, one at a time, until they are all implemented. The drawback of this approach is that the results will be concentrated in one department for quite some time and the other departments may lose interest in the project.

7. Build in automated workflow: For the next release, automate lifecycle tasks and document workflow to streamline approval processes and simplify records retention. As each additional reviewer/approver will extend cycle times, only require review and sign-off where there is a clear business need or regulatory requirement. Ensure that the new process is properly implemented in the system. If it is either too constrained or not constrained enough, you will need to make frequent adjustments to accommodate unforeseen scenarios. These changes can cost time and money if code changes are required and the system needs to be revalidated. Extend the system to include publishing or imaging tools, if needed, in follow-up releases.

In reality, although biotechs and start-up pharmaceutical companies encounter different environmental challenges than the major players, the business issues they face are very similar. Content management systems can provide improved
regulatory compliance and add value to the bottom line. While cost and productivity efficiencies are most frequently realized by automating the regulatory submissions process, significant improvements can also be achieved in the manufacturing and sales and marketing areas. Regardless of function, a manageable, phased approach to system selection and implementation of an electronic content management system is critical to attaining these efficiencies and crucial to the success of the project.