What is an LMS? An enterprise learning management system is a specialized database application that supports the processes and record-keeping activities of a company's various training organizations. Many LMSs focus on specific needs; others serve as unifying applications for a company's diverse learning activities. They manage student information, track training assignments, allow access to web-based e-learning content, provide resources for instructors, control enrollment, and serve as a repository of historical data. (See "It's All Inside," page 88.)

In pharma research, manufacturing, and distribution companies, a comprehensive LMS becomes an important part of the compliance process, keeps the field sales force up-to-date wherever they are, and helps build branding relationships with suppliers, healthcare providers, and the public.

Risk Management In most pharma companies, learning management needs fall into five camps: personal/career development, sales training, operational training, safety training, and compliance. Although all are important to a company's overall mission, compliance training has a significant impact on the company's operations. Unlike development and sales training, compliance training is directly tied to a company's risk management programs. And, although other training areas are now coming under FDA scrutiny, supervisors in those arenas aren't likely to be cited in a 483.

Some systemic training management problems have resulted in high-profile fines, plant shutdowns, and layoffs. Earlier this year, Schering-Plough was fined $500 million for violating good manufacturing practice (GMP) standards at facilities in New Jersey and Puerto Rico, where 13 FDA inspections found inadequate training of manufacturing and supervisory personnel. And in 1997, Centeon (now Aventis Behring) a blood products manufacturer, was placed under an FDA consent decree that prohibited the company from distributing products across state lines. Among other violations, FDA noted Centeon's inability to ensure that sufficient numbers of trained staff were on duty.

In response to the demand for compliance tools, many pharma companies have invested in online learning systems. "E-learning has been adopted most quickly in the high-tech, financial services, consulting, and pharmaceutical industries," says Clark Aldrich, an independent analyst and columnist who formerly headed Gartner's e-learning research group. "Compliance was one of the first reasons for developing learning management systems, and the original LMS companies did a rigorous job of tracking and reporting. Recent laws such as FDA's 21 CFR Part 11, which concerns the security of electronic documents and the Health Insurance Portability and Accountability Act (HIPAA), have re-emphasized the importance of auditability and the value that e-learning can have in automating the incredibly time-consuming tracking and validation process."

According to FDA, LMSs are "quality systems" and, as such, are usually scrutinized at audit time. Many pharma companies have been stung by auditors because of poorly managed or non-auditable training records. A learning platform provides a framework to help keep the quality of records high and to automate the process of collecting and storing training data. Those applications are also a powerful tool for one of the most difficult tasks in regulatory compliance: management of change-specifically, handling revisions to standard operating procedure (SOP) training documents.

For the most part, some type of document-SOP, manufacturing instruction, or building instruction-delivers regulated training. Almost anyone involved in training for GMPs knows those documents tend to change regularly. Revisions of documents used for operations send managers scrambling to find out whether training is necessary and, if so, who needs to receive it. Even if training isn't required, the workers affected by that procedural change must often acknowledge that they have read and understood the revisions. That is where a robust learning system can be invaluable, because it automatically assigns retraining to affected staff and its archive preserves records and notifications of that training.

Sales Training An LMS is also an important tool in companies' constant battle to keep sales reps well trained and up-to-date on the latest product news. Sales forces, with their traditionally high turnover and geographic distribution, are naturals for leveraging an online system's ability to assign needs to employees and deliver

e-learning to meet many of those needs. Saving the travel costs incurred by gathering the sales force at headquarters for training often offsets the upfront costs of licensing the software.

An LMS can provide a remote connection to sales reps, alerting them to changes in product specifications or new competitive information. Those systems also help pharma companies quickly and accurately identify the appropriate sales staff when they change a therapy's interaction or formulation data and deliver training to them wherever they are over the internet.

That ability is even more important now that FDA is scrutinizing sales staff as part of the overall quality chain. Sales people routinely discuss with physicians how medicines work and describe the differentiators between products, so they need to be apprised quickly of manufacturers' changes. Inaccurate or outdated information related by a sales person could lead to prescription errors-a contingency with which FDA is increasingly concerned.

Channels, Customers, More Now more than ever, pharma uses online learning systems to interface with the public. Most companies offer websites on which caregivers and the public can read about their products or find educational resources. Imagine taking that idea one step further by using an LMS to help manage web-based physician education programs. Although most companies may not yet embrace that application, some, including the medical-device companies Guidant and Zimmer and the opthalmology specialty company Alcon, have begun programs.

Companies can use e-learning systems to manage continuing education, because a company's own clinicians use it, and most enterprise learning applications allow users to distinguish between students inside and outside the firewall. The LMS can also be used to develop and manage supplier and service qualifications and other training. Companies could even set up e-mail alerts notifying external students of product changes. Used that way, an LMS automates a framework to manage training-related information and serves the entire operation-from supplier to manufacturer to distributor, then from seller to caregiver, and, ultimately, to the customer.