By Brad Cooper
When wisely selected and implemented, online learning systems can help pharma training departments get back to doing what they do best-training.
As the popularity of online training grows, many pharma companies are likely to implement learning management systems (LMS) that can manage the reams of data generated by training divisions in a regulated environment.
Each company has a different reason for moving its training online. It might want to
This article demonstrates that online learning systems are uniquely suited to the needs of pharma companies and that they can do much more than manage content. Yet there are important differences among them, and the features that are most useful depend on a company's business and training needs.
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. What to Look For How can a company decide which LMS is best? There are many applications on the market, but they vary widely in design and scope. Some only manage e-learning (often called learning content management systems, or LCMS); some manage compliance training, and some focus more on self-directed or competency-based initiatives. For pharma and medical device manufacturing, there are three key issues: scalability, comprehensiveness, and validation.
Scalability. This is a broad measure of how well a software application can shift up from small scale-a low number of users, a small amount of managed data, a simplistic hardware architecture-to a system capable of managing a large, complex enterprise, without slowing down. If a company plans to implement a learning system at one manufacturing facility that has a relatively small head count, scalability is not critical.
But if it intends to roll out the system to tens of thousands of employees in geographically disparate areas where different languages are spoken, scalability is a top priority. In that case, the LMS must meet diverse business requirements and international privacy standards and comply with both US and non-US regulators.
On the technical side, companies that select an application that meets functional requirements 100 percent but is built on a shaky or underpowered architecture do so at their peril. If employees need to connect from home or over telephone lines, applications with minimal client-side software-with no programs or code downloaded to the local computer-are vastly preferable. That is especially true of organizations that don't want to spend time configuring and updating work stations.
Another important element of scalability is the ability to integrate with other software systems. Integrating the LMS with a human resources system automatically drives the entry of students into the training system and manages other student data such as job positions and locations. The system can also be integrated with financial management and other applications, such as document management systems-to automate the revision training process-and with workstation security systems to ensure that operators are trained to handle the latestprocedures.
Comprehensiveness. Many selection processes ensure that basic functions are covered without weighing the company's unique needs. A system that concentrates heavily on web-based e-learning at the expense of instructor-led classroom training is giving short shrift to the management of that type of training, which constitutes between 60 and 80 percent of the training at a typical pharma company.
Many companies choose visually appealing products that perform the basic LMS functions well, only to discover that the system can't perform when expanded to all of the company's training communities-a comprehensiveness as well as scalability problem. A large, diverse organization must meet the needs of as many learning communities-which often have their own language and business practices-as possible. That way, a company can leverage the unifying nature of an LMS instead of buying yet another system that must be integrated into the network.
Validation. Software's capacity for validation-through exhaustive testing designed to prove that it does what it says it can do-is, of course, another major driver. Most pharma and medical device companies' quality assurance staff will insist that it's the main driver because choosing an inappropriate system can be wasteful and even risky. Any learning system used in an FDA-regulated environment must have an audit trail for GxP data-industry shorthand for good manufacturing, clinical, and laboratory practices. It also must provide sufficient system security and, if a company uses electronic records, electronic signature functionality that complies with 21 CFR Part 11.
A list of the ten most frequent GMP violations, released by FDA auditors at a recent conference, identified "lack of process and computer validation" as the number-one offense and named "inadequate employee training" as another.
Although an LMS vendor cannot perform the validation itself, it can certainly help with documentation and references of customers that have been validated before. Vendors should be straightforward about how they manage potential validation risks based on defects discovered in a product. They should be willing to support onsite vendor audits and should be knowledgeable about validation issues. A company's quality assurance staff should sit down with the vendor early in the evaluation process to gauge their own level of comfort with the vendor's knowledge in that area.
Finally, companies should be wary of promises of future functionality. It's not uncommon for a vendor to promise to add new features and functions to meet a customer's requirements. That isn't necessarily a bad thing, as long as the vendor really knows what it will develop and can describe it in detail. Companies should be especially vigilant about promises that relate to the auditability of the application. Implementing functionality to meet FDA requirements is complex; software vendors must understand the relevant regulations, preferably through experience with more than one customer.
Most pharma companies have their own interpretations of how to meet FDA requirements. An application that was built to meet one company's regulatory interpretation can result in an application that calculates, stores, and displays data in a way that is unique to that company and can't readily be applied to others.
Build Versus Buy Usually the first thing companies discover in the market for enterprise learning software is that nobody makes a system that completely meets their needs. In fact, in the commercial off-the-shelf software (COTS) development world, it's considered a success to meet 75 percent of a customer's requirements without customization.
So, why shouldn't a company's IT staff or a consultant build one from scratch? The economics of design, delivery, and maintenance make it unwise to build an LMS from the ground up. In addition, it takes software architects, functional designers, and software engineers to create an application and many designers and engineers to maintain and update it, especially with FDA continually releasing guidances that make incremental, but critical, changes to the interpretation of regulations. In addition to software maintenance, COTS products incorporate technological and functional improvements with each new release-often from customer feedback, industry trends, and instructional advances.
Furthermore, it takes much more time to design and build custom learning systems than it takes to install and integrate COTS applications. FDA tightened requirements on all applications that are used as part of a company's quality system, and there's a considerable difference between understanding validation test scripts for unfamiliar functions and validating a system that has already been tested at other companies.
Nevertheless, the "build versus buy" debate is not a black-and-white issue. There are many circumstances in which companies might choose to build their own LMS solution. Stringent security concerns, unique workflow issues, non-standard technology limits, and access to software engineers all drive companies to build in-house. The key is weighing the costs, both current and ongoing, against the compromises a company must make to develop the best tool for its needs.
Each company has a different reason for moving its training online. It might want to
- reduce sales staff training time
- avoid negative 483s-the reports FDA staffers file after inspections-which frequently focus on software testing and poor employee training
- make it part of an overall productivity improvement initiative.
This article demonstrates that online learning systems are uniquely suited to the needs of pharma companies and that they can do much more than manage content. Yet there are important differences among them, and the features that are most useful depend on a company's business and training needs.
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. What to Look For How can a company decide which LMS is best? There are many applications on the market, but they vary widely in design and scope. Some only manage e-learning (often called learning content management systems, or LCMS); some manage compliance training, and some focus more on self-directed or competency-based initiatives. For pharma and medical device manufacturing, there are three key issues: scalability, comprehensiveness, and validation.
Scalability. This is a broad measure of how well a software application can shift up from small scale-a low number of users, a small amount of managed data, a simplistic hardware architecture-to a system capable of managing a large, complex enterprise, without slowing down. If a company plans to implement a learning system at one manufacturing facility that has a relatively small head count, scalability is not critical.
But if it intends to roll out the system to tens of thousands of employees in geographically disparate areas where different languages are spoken, scalability is a top priority. In that case, the LMS must meet diverse business requirements and international privacy standards and comply with both US and non-US regulators.
On the technical side, companies that select an application that meets functional requirements 100 percent but is built on a shaky or underpowered architecture do so at their peril. If employees need to connect from home or over telephone lines, applications with minimal client-side software-with no programs or code downloaded to the local computer-are vastly preferable. That is especially true of organizations that don't want to spend time configuring and updating work stations.
Another important element of scalability is the ability to integrate with other software systems. Integrating the LMS with a human resources system automatically drives the entry of students into the training system and manages other student data such as job positions and locations. The system can also be integrated with financial management and other applications, such as document management systems-to automate the revision training process-and with workstation security systems to ensure that operators are trained to handle the latestprocedures.
Comprehensiveness. Many selection processes ensure that basic functions are covered without weighing the company's unique needs. A system that concentrates heavily on web-based e-learning at the expense of instructor-led classroom training is giving short shrift to the management of that type of training, which constitutes between 60 and 80 percent of the training at a typical pharma company.
Many companies choose visually appealing products that perform the basic LMS functions well, only to discover that the system can't perform when expanded to all of the company's training communities-a comprehensiveness as well as scalability problem. A large, diverse organization must meet the needs of as many learning communities-which often have their own language and business practices-as possible. That way, a company can leverage the unifying nature of an LMS instead of buying yet another system that must be integrated into the network.
Validation. Software's capacity for validation-through exhaustive testing designed to prove that it does what it says it can do-is, of course, another major driver. Most pharma and medical device companies' quality assurance staff will insist that it's the main driver because choosing an inappropriate system can be wasteful and even risky. Any learning system used in an FDA-regulated environment must have an audit trail for GxP data-industry shorthand for good manufacturing, clinical, and laboratory practices. It also must provide sufficient system security and, if a company uses electronic records, electronic signature functionality that complies with 21 CFR Part 11.
A list of the ten most frequent GMP violations, released by FDA auditors at a recent conference, identified "lack of process and computer validation" as the number-one offense and named "inadequate employee training" as another.
Although an LMS vendor cannot perform the validation itself, it can certainly help with documentation and references of customers that have been validated before. Vendors should be straightforward about how they manage potential validation risks based on defects discovered in a product. They should be willing to support onsite vendor audits and should be knowledgeable about validation issues. A company's quality assurance staff should sit down with the vendor early in the evaluation process to gauge their own level of comfort with the vendor's knowledge in that area.
Finally, companies should be wary of promises of future functionality. It's not uncommon for a vendor to promise to add new features and functions to meet a customer's requirements. That isn't necessarily a bad thing, as long as the vendor really knows what it will develop and can describe it in detail. Companies should be especially vigilant about promises that relate to the auditability of the application. Implementing functionality to meet FDA requirements is complex; software vendors must understand the relevant regulations, preferably through experience with more than one customer.
Most pharma companies have their own interpretations of how to meet FDA requirements. An application that was built to meet one company's regulatory interpretation can result in an application that calculates, stores, and displays data in a way that is unique to that company and can't readily be applied to others.
Build Versus Buy Usually the first thing companies discover in the market for enterprise learning software is that nobody makes a system that completely meets their needs. In fact, in the commercial off-the-shelf software (COTS) development world, it's considered a success to meet 75 percent of a customer's requirements without customization.
So, why shouldn't a company's IT staff or a consultant build one from scratch? The economics of design, delivery, and maintenance make it unwise to build an LMS from the ground up. In addition, it takes software architects, functional designers, and software engineers to create an application and many designers and engineers to maintain and update it, especially with FDA continually releasing guidances that make incremental, but critical, changes to the interpretation of regulations. In addition to software maintenance, COTS products incorporate technological and functional improvements with each new release-often from customer feedback, industry trends, and instructional advances.
Furthermore, it takes much more time to design and build custom learning systems than it takes to install and integrate COTS applications. FDA tightened requirements on all applications that are used as part of a company's quality system, and there's a considerable difference between understanding validation test scripts for unfamiliar functions and validating a system that has already been tested at other companies.
Nevertheless, the "build versus buy" debate is not a black-and-white issue. There are many circumstances in which companies might choose to build their own LMS solution. Stringent security concerns, unique workflow issues, non-standard technology limits, and access to software engineers all drive companies to build in-house. The key is weighing the costs, both current and ongoing, against the compromises a company must make to develop the best tool for its needs.
7 comments:
Great thoughts you got there, believe I may possibly try just some of it throughout my daily life.
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IT staff or a consultant build one from scratch? The economics of design, delivery, and maintenance make it unwise to build an LMS from the ground up.
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Great thoughts you got there, believe I may possibly try just some of it throughout my daily life.
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