Life Science companies, which trade in a regulated industry that is essentially risk-conscious, are cautious when assessing an enterprise-wide learning management system (LMS) to ensure that the system adheres to the requirements of EU Annex 11 and 21 CFR Part 11. However, few LMSs provide this functionality at several depths and in certain cases this is not found until after the system is purchased.
It is essential that functionality meets EU and US electronic recordkeeping requirements including automated version controls for electronic records, signatures and training materials, otherwise it places unnecessary compliance pressure on the QA team.
Companies can become more dependent on manual qualification processes to improve their business, when there are such LMS deficiencies. Such “workarounds” drain profitability, increase the risk of data integrity errors, and expose the organization to observations related to EU Annex 11 and 21 CFR Part 11.
When buying an enterprise learning platform, it is essential to make a well-informed purchase decision. Since LMS vendors do not offer a complete presentation of how these requirements are addressed in the application, things can go wrong in the software evaluation process or RFP.
In many cases, the IT and Quality Assurance (QA) teams in a Life Science company are responsible for choosing a LMS that meets the internal audits, or fulfills the regulatory electronic recordkeeping requirements or risk increased scrutiny during external audits.
This article offers seven risk areas that the IT and QA validation teams should examine while assessing an LMS (Figure 1).
Figure 1. LMS functionality gaps lead to cascading consequences.
Risks, gaps and remedies
As the name suggests, Life Science LMS solutions are designed to facilitate the management of learner proficiency, compliance status, and training activities while reducing the financial risks involved in quality deficiencies, inadequate training record management, poor policy distribution management, and non-compliance.
Increasing the level of vigilance to detect potential weaknesses before they become post-purchase performance gaps and risks, is a strong strategic method to make a LMS operate effectively across your footprint.
Most of the functions, user benefits, and features that are essential for an LMS may not be not clearly detected during the needs assessment stage of the RFP or may get subordinated into larger issues, whistles and bells during vendor presentations.
Despite such issues, there are measures that can be taken to remove these inherent risks upfront, to ensure that a company is better prepared and well-equipped to fulfill its regulatory compliance requirements laid down by FDA.
It is essential to maintain thorough due diligence, evaluate the company’s scope of learning management needs, and prepare a punch list. A company must look beyond its service deliverables package of its RFP vendor.
A company must ask detailed, probing questions regarding the function and features that are critical for the organization, but are not mentioned in the vendor’s proposals.
The functionality risks associated with top LMS system software will differ according to specific requirements and needs of every user company. Seven of the major risk concerns and the associated gaps are mentioned in this article, along with the recommended remedies that can help a company to detect and prevent these risks when selecting an LMS.
Risk 1
There is not sufficient version control in the training content. The lack of version control increases the risk of human error, as multiple version reconciliations and updating, increase the collection of ever-changing training documents have to be performed manually.
Gap
There is a lack of automated process for versioning training documents and revising training curriculum with the latest version.
This can lead to considerable administrative inefficiency, and can give the impression that the company has failed to deploy and maintain a compliant quality initiative to the regulatory authorities. This can expose the company to CAPA directives, potential 483 observations, and more scrutiny depending on inspection outcomes.
Remedy
Obtaining version control capabilities can eliminate manual reconciliations for a growing volume of multiple material versions. It protects the company against the issuance of warning letters, 483s, and other audit remediation directives. It enhances the operating efficiency of both system and quality administration.
Risk 2
Lack of automated electronic signatures or eSignatures increases the level of incomplete training outcomes and record retention, and places the maintenance of training documentation out of compliance with 21 CFR Part 11.
Gap
eSignatures need additional administrative activity as they do not appropriately and automatically add to all the courses introduced to the training program, and thus can confuse the learners.
Remedy
Electronic signatures and records compliant with stringent requirements of FDA 21 CFR Part 11 and EU Annex 11 will allow the following tasks:
- The eSignature must be developed at the completion of the training. It must maintain security and audit trails to ensure it is a flawless record.
- Validation of systems to ensure reliability, accuracy, the ability to discern altered or invalid records, and consistent intended performance
- Generation of complete and accurate copies of records in both electronic and human readable form suitable for inspection, appraisal, and copying by the regulatory agency
Risk 3
Lack of sufficient audit trail data on curriculum profiles and learner training items.
Gap
Limited information on what was changed and who made the change, inability to retain the data for the required time period, and lack of date and time-stamp capability. This dampens the training program control and monitoring, and reduces the ability to develop a comprehensive, end-to-end task audit trail.
The failure of LMS to record both old and new performance benchmarks makes the system non-21 CFR Part 11 compliant. The need to manually monitor who is inputting the system changes, the date and time the changes were made, and who made the changes, can also make the LMS non-21 CFR Part 11 compliant.
Remedy
The time and date of operator entries and actions that develop, alter, or erase electronic records can be independently recorded by secure, computer-generated, date and time-stamped audit trails.
Risk 4
All administrative and management approvals will have to be performed manually, outside the LMS if the training plan approval process capability are deficient.
Gap
Management incapable of assessing individual training plans against employee job descriptions in order to ensure accuracy when hired, and updated when there is a change in role.
With increasing incidence of manual labor essential to compensate for the lack of automated processes, the margin for human error will also increase. Additional personnel will also have to be deployed to facilitate a manual review of the training program.
Remedy
Periodic, automated reviews of training plan functionality:
- Minimizes the dependence on manual, administrative activity
- Can be modified to match the internal training record retention disciplines
- Maximizes accountability, oversight, and control of training plan reviews
Risk 5
Insufficient “audit-ready” reports for managers and administrators that indicate the real-time qualifications status of learners.
Gap
Administrators and managers must have immediate notification of, and access to, the qualification and compliance level of their employees. These reports also need to be presentable during an audit. They must have all necessary data, so that it is clearly represented from a trustworthy and accurate source.
Remedy
Automated training reports and notifications in real-time that can detail the qualification and compliance status of learners:
- Notifies both system administrators and managers via e-mail when an employee's assignment is overdue
- Offers current access to training records in real-time
- Produces “audit-ready” reports in pdf format with date/time stamps, report criteria, page numbers, etc.
Risk 6
As the features of LMS and matching functionality that govern the role-based training process are insufficient, the staff involved in the quality system cannot be grouped into automated roles depending upon their job functions.
Gap
Development, evaluation, approval, and assignment of individual training plans have to be done manually when there is no automated role-based training management features.
This raises the issue of human errors and can give the auditors the impression that the training plans are inconsistently assigned. It can indicate that the employees are not being sufficiently trained before performing the activity.
Remedy
Full automation of the necessary training plans from employee onboarding to ongoing qualification for those staff involved in GxP initiatives:
- Ensures the creation of consistent training records for the same courses, and consistent reporting and tracking
- Enables the staff fulfill the training goal requirements essential to access systems or conduct operations
- Ensures the right people are trained at the right time on the right material
Risk 7
Administrators and managers are unable to clearly evaluate, lay down, allocate and report equivalent training performed in several training modalities/ methods.
Gap
The existing LMS are incapable of tracking the training equivalencies between various learning activities. The functionality available to address those equivalencies is limited, and only the same training method/ type can be made equivalent.
For instance, English and German versions of the same material can be made equivalent, but different forms of learning sources are beyond this parameter. Therefore, a read and sign training on an SOP or an instructor-led training on an SOP is not developed as, or viewed as an equivalent in the LMS.
Remedy
Tracking of training equivalency between various learning sources:
- Minimizes the human error caused by manually handling employee training completions and omission of tracking records
- A master report for each type of training can be consolidated by system administrators, making it easier to run reports and respond to internal data requests and audit inquiries
Pick your partner wisely
Quality and compliance comprise of the core of the Life Science learning system. Therefore, it is best for a company to not limit itself to just those top LMS vendors whose market penetration and size could hide their inefficiencies associated with critical compliance features, but to consider qualified LMS vendors. A Life Science company can be exposed to the most operational risks due to these compliance features.
New and agile providers who are capable of providing similar or superior capabilities in many areas as compared to the top market providers have emerged1. These companies often show an advanced expertise of their craft in contrast to the “Jack of all trades, master of none” approach of their clumsy counterparts.
These companies may also have a competitive advantage by providing greater capabilities, such as content, unique system features and functionality, or special advisory services, in many fields common to all businesses.
Although most of the LMS programs provided through leading companies are advanced, some are not designed to suit the operations of a regulated industry, and others are not capable of providing the level of granularity required to ensure that all compliance and quality training requirements are met.
In order to avoid such shortcomings, a company can contact a provider who has worked successfully with companies similar to itself, is “nuanced” within the particular industry, and is capable of:
- Reflecting an understanding of the business and the ability to work with the business
- Providing complete disclosure on full service offerings and ensuring optimal functionality
- Providing a company the ability to completely audit its system and operations
- Ensuring the system is easy to administer in-house
- Remaining flexible when creating solutions to fit users so that they can leverage them
- Partnering with a company in its migration or transition to the learning management space
References
- The Definitive Buyer’s Guide to the Global Market for Learning Management Solutions 2014, Bersin by Deloitte, August 2014.
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