quality and compliance: the core of the life science ... · the qa team is responsible for...

Quality and Compliance: The Core of the Life Science Learning SystemBy Rob Sims, Director, Life Science, UL EduNeering

Within today’s Life Science organizations, learning needs span a wide range of departments and functions. A short list of these departments includes Corporate Compliance, Human Resources, Leadership Development, Sales and Marketing, Product Development, Manufacturing and Quality Assurance (QA).

This paper focuses on the QA team, who is responsible for meeting global regulatory requirements and assuring that individuals have been trained and are qualified for their job functions. As with any industry, a Life Science organization can gain a competitive advantage by delivering learning programs that focus on professional development, leadership training, product education and performance improvement. However, the “regulatory cloud” that hangs over the Life Science company forces the QA team, as well as the Validation and IT teams, to evaluate Learning Management Systems (LMS) based on the product’s ability to address regulatory functionality in the most efficient and cost-effective manner possible. This can only be accomplished if the regulatory requirements are “embedded” into the LMS architecture and the product’s core design, rather than programmed into the system that wasn’t initially developed to meet these requirements.

While professional development and talent management programs led by HR, sales, marketing and product development are critical to a company’s long-term growth, we know that companies struggle with noncompliance when quality and compliance regulatory requirements are not embedded in the corporate learning system.

So when a Life Science organization evaluates corporate-wide learning systems, the needs of QA should be the highest priority. This point was underscored in a 2012 survey of 200 Life Science companies, conducted by market research firm Lead to Market and sponsored by UL EduNeering. The survey revealed that for the most part, QA does have a voice in the learning system evaluation process. The presence of QA also demonstrates to regulators and other stakeholders that senior management has made a commitment to quality and compliance and also recognizes the business benefits of embedding quality into the cultural fabric of their organizations.

ExECuTivE Summary: Quality and Compliance – The Core of the Life Science Learning SystemBy Rob Sims, Director, Life Science, UL EduNeering

Quality and Compliance: The Life Science Learning System

Does Quality Have a voice in Learning System Selection? In Q1 2012, Lead to Market conducted a survey of 200 Life Science companies to better understand the role that QA plays in selecting the corporate learning system. Because the QA team is responsible for achieving the regulatory compliance obligations, including Good Manufacturing Process (GMP) training, the specific learning requirements must address these areas:

• Ability to support role-based qualification training programs

• Ability to develop GMP-focused and other regulatory curricula

• Ability to meet FDA validation and 21 CFR Part 11 requirements

• Ability to generate reports for regulatory-focused audits to demonstratea commitment to ongoing compliance

In the survey, leading quality executives were asked if they had a “seat at the table” during the learning system evaluation process. Among the departments represented, QA had the strongest voice, which demonstrates that most senior managers understand the critical role that QA performs within the company:

Delving deeper into the QA role in evaluating learning systems, we have identified these three areas as the greatest “quality/compliance” requirements:

1. Alignment of the program to the organization’s quality management process

2. Ability to achieve ongoing validation requirements, especially as the learning technology evolves

3. Ability to readily accommodate individual company business requirements, such as M&A activity, global expansion, contractor relationships and product expansion

Clearly, an LMS designed for “general” professional development is not likely to contain some of the “quality-focused” learning requirements. This point was also underscored in the survey, in which respondents who had indicated that their company was evaluating an LMS were asked if they were satisfied with their current system. About half of the respondents were marginally satisfied or not satisfied that their regulatory demands were being met by the selection process.

Key Topics

Does Quality Have a Voice in Learning System Selection?

Why Quality-Related Learning Remains Priority #1

The Quality-Focused LMS Focuses on Standardization and Validation

Addressing the Critical Needs of HR, Sales and Other Areas

Summary

What Requirements Matter Most to QA?

Which of the following departments will be a part of the selection team? Check all that apply.

QA Y/N 75.00%

HR Y/N 53.57%

Corporate Training Y/N 32.14%

Leadership and Development Y/N 25.00%Procurement Y/N 17.86%Other 10.71%


Why Quality-related Learning remains Priority #1In the Life Science industry, the risks of noncompliance are significant in regards to product quality and patient safety. From our survey, we learned that almost 90 percent of respondents thought it was important that the LMS be specifically designed to meet their Life Science industry needs.

Another key consideration for LMS selection involves the FDA’s computerized system validation requirements. According to the FDA, validation is the formalized documented process for testing computer software and systems, required by a specific Code of Federal Regulations (21 CFR 11.10.a). Failure to validate systems can lead to an FDA 483 Observation or even a Warning Letter. To be compliant, Life Science companies must validate all of their software, databases, spreadsheets and computer systems and develop the appropriate documentation for all phases of the Software Development Life Cycle (SDLC).

QA is responsible for meeting global regulatory requirements and assuring that individuals have been trained and are qualified for their job functions. In the United States, the FDA has defined stringent regulations around trained and qualified personnel. Likewise, in the European Union (EU), companies must demonstrate that both personnel and “qualified personnel” – those responsible for conducting the training – have been adequately trained. In addition, both US- and EU-based Life Science companies must meet stringent computerized system requirements, such as validation, electronic copies, audit trails, record retention and more, as mandated by 21 CFR Part 11 and EU Annex 11.

On a scale of 1 to 5, 1 being not important at all, 5 being very important, how important is it for your organization to use a learning management OR training management system specifically designed for the Life Science industry?

1 10.71%

2 7.14%

3 25.00%

4 46.43%

5 17.86%

On a scale of 1 to 5, 1 being not satisfied at all, 5 being completely satisfied, how satisfied are you that QA’s needs for GMP and/or Regulatory Compliance training management (Part 11 system, SOP training, etc.) are being met by the entire selection process?

1 3.57%

2 7.14%

3 39.29%

4 35.71%

5 21.43%


The QA team needs an LMS that can ensure – and enforce – standardization, organization and reporting of specific and meaningful role-based “qualification” requirements. According to regulations, employees must be able to demonstrate documented qualification that they can perform their specific job functions. “Qualification” could be represented by a collection of “role-based” training items or tasks that must be completed to satisfy the defined expectations of the training manager or department manager.

To fulfill this qualification requirement, managers must be able to collect and organize all of the “training items” related to a specific job function or role. The training materials or tasks can be grouped

into certification-based curricula. Without these documented standards, the QA team cannot receive consistent and meaningful reporting metrics that are measurable at every level within the company.

Curricula are required at different levels of the organization. For example, a facility may require that all employees understand safety policies. That means the LMS must be able to organize groups of learners in many different ways: by region, by facility, by department and finally, by role. As the graphic below shows, ensuring compliance with these many levels requires an LMS that can place an individual into as many groups as necessary to fulfill the mandated or prescribed training within the organization.

Corporate& Divisional

Requirements

Facility-Specific

Functional Knowledge

Job-Specific

COMPANYLEVEL

DEPARTMENTLEVEL

ROLELEVEL

LOCATIONLEVEL

Corporate& Divisional

Requirements

COMPANYLEVEL

Facility-Specific

LOCATION LEVEL


DEPARTMENT LEVEL

Job-Specific

ROLE LEVEL Corporate& Divisional Requirements

COMPANYLEVEL

Facility-Specific

LOCATION LEVEL


DEPARTMENT LEVEL

Job-Specific

ROLE LEVEL

The Quality-Focused LmS Focuses on Standardization and validation

From our survey, we learned that almost 90 percent of respondents thought it was important that the LMS be specifically designed to meet their Life Science industry needs.


Despite the regulatory requirements to address 21 CFR Part 11 and EU Annex 11 regulations, QA requirements are not the only critical learning areas that will drive a company’s growth. Dozens of studies have demonstrated that talent management and related leadership and professional development training programs, along with the sales and marketing management teams, are critical for retaining top performers and driving new business.

The question that Life Science companies have to address is how to manage a single corporate learning system that satisfies the regulatory obligations, while cost-effectively delivering talent management and leadership development programs for the organization.

Some companies have solved the issue by investing in more than one learning system. This enables HR and Leadership to manage their programs while Quality and Compliance manage their programs in

SuppliersContractorsEmployees

Portal Portal Portal

InternalContent:

ILTPoliciesVirtual

SCORM Courses

Third PartyContent Vendors:

AICCThird Party

Corporate-WideSystems:

HRISActive Directory

EDMSCTMS

Biometrics

Compliance / 21 CFR Part 11 Talent and Development

Security Protocol

Security Protocol

Platform Tools:Control Document

ManagementTool

Assessment Tool

FormsTool

Leadershipand Succession

Planning180, 360 and

Self-Assessments

addressing the Critical Needs of Hr, Sales and Other areas


SummaryIn a Life Science organization, a true enterprise learning architecture should support goals for the management of all learning activities, across all areas of the company. However, the regulatory pressures facing Life Science companies are monumental and implementing a learning program that is not aligned with the quality management system can threaten production output, brand reputation and long-term growth.

That’s why leading Life Science companies evaluating corporate learning systems place a high priority on the needs of the QA team, building an architecture that enables other areas of the company to recognize their needs without sacrificing their commitment to quality and compliance.

This separation ensures that IT and validation teams can focus their “validation” attention only to the 21 CFR Part 11 learning database.

the validated environment. What's more, Quality and Compliance can generate reports for audits that target only the qualification and compliance activities.

However, we are seeing a more intriguing solution that delivers a seamless front-end experience for the end user. A single interface portal has been created, often using “single sign on” so that the user who logs into the network system can simply visit the corporate learning portal, which then directs the learner to the appropriate content: skill development, compliance training, performance management, etc. The front-end portal can be refined for nonemployees as well, in alignment with an existing supplier or contractor extranet.

In the back end, the HR/Sales programs reside on their own servers in a non-validated environment, separated from the compliance and quality system. This separation ensures that IT and validation teams can focus their “validation” attention only to the 21 CFR Part 11 learning database. What’s more, this segmentation ensures that the investment in talent and professional development programs, in which a more dynamic and collaborative environment is required, won’t compromise the mandated regulated obligations for training and documentation, as the diagram illustrates.


LmS Functional requirements: (listed alphabetically) Comments from uL EduNeering:

Administrator Management Experience; Tracking and Scheduling Assignments and Notification Management

For compliance purposes, e-mail notifications need to be scheduled based on the compliance need: daily reminders, weekly reminders, etc. The LMS should provide this flexibility based on the compliance policies established by the company.

Assessment Management (Testing and Evaluation)

Whether the training item is an electronic version of an SOP, or a video or classroom event, compliance managers need to measure proficiency and retention. The LMS should provide the ability to “attach” a quiz to any training item so that the learner cannot complete the activity until they receive a passing grade on the quiz.

Coding Nomenclature QA often “codes” each training item for audit reporting and assignment purposes. The LMS needs to support a unique code for each training item.

End User Experience End users need a simple, intuitive interface that enables them to complete training and view their progress at any time. This is true of any LMS, but may be especially true of an LMS focused on compliance-related training.

Host Online Content When QA shares SOPs and other documents, this content needs to be uploaded to a secure server so that learners can access the files outside the company firewall.

Languages The LMS needs to support multiple languages – especially critical SOPs – and provide the ability to “roll up” multiple language versions of the same training item so administrators can properly assign and track completions for auditing purposes.

Reporting and Analysis: Standard and Custom Reporting and Scheduling

The LMS must deliver both standard and customized reports that focus on “role-based” curricula completions. That is, reports that display who is “Qualified” or “Partially Qualified” based on a “job function” curricula. In addition, the LMS must provide the ability to store department specific training status reports that enable managers and supervisors to “own” compliance training completions.

LmS Functional requirements:

To understand exactly what is expected of an LMS that is “designed for the Life Science industry,” we revisited approximately two dozen “Request for Proposals” for corporate learning systems that we received from Life Science companies since 2010. What we learned from this analysis was that the same requirements were being cited in nearly

of all of the RFPs we reviewed. We have segmented these requirements into three major categories:

• LMS Functional Requirements

• Technical Requirements

• Service and Support Requirements

We analyzed the requirements and identified which of the specific

requirements within these categories were of the highest priority for the QA team. The chart lists “key priority needs” of QA. In some RFPs, QA provided their own priorities, but others did not have priority scores. We applied our own experiences supporting the Quality teams within our 200 Life Science clients using ComplianceWire.

What requirements matter most to Qa?


LmS Functional requirements: (listed alphabetically) Comments from uL EduNeering:

Risk-Based Approaches to Learning that Minimizes High-Risk Activities

The LMS should provide the ability to identify who in the organization conducts “high risk” activities versus other activities. With this information, training managers can target high-risk end users with more focused training.

Support for Mobile Devices As more and more sales teams use iPads and related mobile devices, compliance content must be delivered to these devices.

Support for Virtual Classroom Activities Compliance training delivered via a webinar or virtual classroom must be captured within the LMS.

Training Management: Course and Curricula, Classroom Registration, Catalog, On-the-Job Assessments and Blended Programs

The LMS must support a wide variety of training types, including on-the-job assessments and monitoring. These types of training activities are common in the FDA regulated environment.

Training Management: Role-based curricula based on specific job functions

The LMS must support role-based curricula and role-based user groups, based on job functions and “hierarchy” within the organization. For example, every employee in the facility may need workplace safety training, but only specific job functions require training on equipment SOPs. The LMS should be able to connect the “Facility” compliance training to the “Equipment SOP” training so that the administrative effort is reduced and reports are more focused and targeted for audit purposes.

Training Management: SOP Management The LMS must support SOP management and the versioning and retraining rules that accompany each SOP. This means “wrapping” a training assignment around the electronic version of the document and then linking to that specific document on the network or within the document management system.

Version Control: Ability to set a new version 1.1

Not all LMSs provide this level of version control, but QA needs the ability to “up version” an SOP so that it automatically triggers a new training assignment; this may not be a major requirement outside of FDA-regulated industry, but a core requirement of QA within the industry.

LmS Functional requirements (continued):


Technical requirements: (listed alphabetically) Comments from uL EduNeering:

Application Architecture The SaaS LMS should provide a “two tier” architecture so that access to the data is achieved via database procedures.

Application Security Security and data protection should receive the highest priority from the LMS vendor. As such, the vendor should make sure that infrastructure level security be enforced with SOPs that cover firewalls, servers, network hardware configurations, virus scanning, system hardening and encryption. All of these SOPs should be available for review during an audit of the vendor’s facility.

Data Architecture The LMS design should be redundant at every level so there is no single point of failure. The entire site should be mirrored to a “disaster recovery” site and synchronized at least every 15 minutes.

Data Center (Cloud Applications only) The LMS vendor needs to maintain redundant data centers and have a fully documented and tested disaster recovery and business continuity plan.

Enhancements With a cloud computing LMS, clients should expect regularly scheduled enhancements with minimal interruptions to service or client downtime and without additional costs. For validation purposes, the LMS vendor must provide test scripts to clients, which would greatly minimize the validation effort by clients, as opposed to a server-based LMS “upgrade,” which would require additional IT and validation resources.

Electronic Records and Signatures: compliant with FDA 21 CFR Part 11 and EU Annex 11

The LMS should be designed to meet the strict requirements of 21 CFR Part 11, which includes a number of requirements such as:

• Validation of systems to ensure accuracy, reliability, consistent intended performance and the ability to discern invalid or altered records.

• The ability to generate accurate and complete copies of records in both human readable and electronic form suitable for inspection, review and copying by the agency.

• Use of secure, computer-generated, time-stamped audit trails to independently record the date and time of operator entries and actionsthat create, modify or delete electronic records.

Technical requirements:


Technical requirements: (listed alphabetically) Comments from uL EduNeering:

Integration with Other Applications The LMS should provide application interoperability with document management systems, HR systems, Manufacturing Execution Systems and others.

Integration with Third Party Content Providers (Off-the-Shelf Learning Content)

The LMS should be able to support SCORM and AICC-compliant content. The LMS should provide the ability to upload SCORM content to a secure server.

Policies and procedures that dictate the development of software requirements

Unlike other LMS vendors, one focused on the Life Science industry must have development specifications that are developed in stages that reflect a Software Development Life Cycle methodology (SOP SDLC1). Specific documentation should be generated during each of the SDLC stages.

QA Process The LMS vendors' QA team should include experienced validation experts.

Single Sign On Support – either Security Assertion Mark Up Language (SAML) technology or Lightweight Directory Access Protocol (LDAP)

The LMS vendor should have experience with active directory authentication via secure LDAP and SAML. The LMS should require an ID, Password and company code to authenticate a user. Our Professional Services team has created Single Sign On. The LMS also should contain interoperabilities that enable end users to access the system using existing company sign-in methods, including biometrics.

Services and Support requirements: Comments from uL EduNeering :

Help Desk Support The LMS vendor should supply 24/7 help desk support.

Hosting an On Site Audit: Audit or Sourcing Team May Need to Visit Vendor Facility

The LMS vendor should host the client for regular audits, sharing all procedures and policies.

Product Implementation and Integration Information

The LMS vendor must provide an experienced product deployment team that can share best practices from dozens of related Life Science company deployments.

Audit Support The LMS vendor’s help desk team must be available when clients are facing audits so they can provide reporting best practices.

Training, Documentation and Support Services

The LMS vendor must provide administrator training programs and complete documentation related to the system functionality.

Technical requirements (continued):

Service and Support requirements:

www.ULEduNeering.com

202 Carnegie Center Suite 301 Princeton, NJ 08540 609.627.5300

UL and the UL logo are trademarks of UL LLC © 2012.

about uL EduNeeringUL EduNeering (www.ULEduNeering.com) is part of UL LLC, a global independent safety science company offering expertise across five key strategic businesses: Product Safety, Environment, Life and Health, Knowledge Services and Verification Services.

UL EduNeering develops technology-enabled knowledge solutions for improving business performance and helping to assure regulatory compliance. For more than 30 years, the company has served corporate and government customers in the Life Science, Health Care, Energy and Industrial sectors using proprietary learning management platforms that integrate business, learning and technology.

For more than 10 years, under a unique partnership with the FDA’s Office of Regulatory Affairs (ORA), UL EduNeering has provided the online training, documentation tracking, and 21 CFR Part 11-validated technology system for ORA-U, the FDA’s virtual university.

UL EduNeering is also the exclusive online partner for compliance solutions to AdvaMed and the Medical Technology Learning Institute (MTLI), delivering compliance education to AdvaMed’s members, including an engaging online course on the AdvaMed Code.

UL EduNeering and the Drug Information Association (DIA) formed a strategic alliance to create online educational offerings for biotechnology, pharmaceutical, academic, and regulatory professionals around the world. DIA members gain access to UL EduNeering’s online compliance solutions, which are used by over one million individuals in more than 50 countries.

quality and compliance: the core of the life science ... · the qa team is responsible for...

Documents