A Model for Training/Qualification
Record Validation within the Talent
Management System
IN THIS PAPER:
• Meeting 21 CFR Part 11 and Annex 11 Requirements • Delivering Qualification Transcripts During Audits
Summary:
As Life Science companies invest in Talent Management Systems (TMS), in which
learning management is a key component, the question often arises: what does
FDA expect the company to validate?
What’s driving this question is the fact that FDA and EMA expect software that
interacts with the quality system to be validated, and this would include the
Learning Management System (LMS) that stores training and qualification records.
When an employee enrolls in performance management and development
activities, these should not impact the employee’s qualification, and therefore fall
outside of the validated state.
In this paper, we present a model by which FDA-regulated companies can validate
the LMS component, rather than the entire TMS, which may include tools that
focus on performance management, goal setting and competency management.
Focusing the validation effort on the “qualification record” provides a number of
benefits to the TMS sponsors, often the HR team, as well as the IT validation and
QA teams.
Page 3
A Model for Training/Qualification Record Validation
within the Talent Management System
By Rob Sims, Life Science Practice Leader, UL EduNeering
Addressing FDA Validation Requirements
FDA defines “validation” as the establishment of “documented evidence that provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes.” That said, FDA actively regulates two categories of software:
•
Software that is used for or to support regulated activities (e.g., manufacturing, quality assurance, clinical data management, regulatory recordkeeping)•
Software that is a medical device (or a medical device component or accessory) According to the FDA, computer system validation is the formalized, documented process for testing computer software and systems required by Federal Regulations (21 CFR 11.10.a). Validation requirements for medical device companies are found in the Production and Process Controls regulations [21 CFR 820.70]:“When computers or automated data processing systems are used as part of production or the quality system, the manufacturer shall validate computer software for its intended use according to an established protocol. All software changes shall be validated before approval and issuance. These validation activities and results shall be documented.”
To be compliant with FDA regulations, Life Science companies must validate all of the software, databases, spreadsheets and computer systems that impact quality systems. They must also develop the appropriate documentation for all phases of the Software Development Life Cycle (SDLC).
Note in the EU, Annex 11 has a similar focus on the product life cycle, but also places more emphasis on “people” and management accountability than the US regulations.
Validation activities applies to all intended use requirements such as inputs to be captured, processing requirements, outputs from the system, business needs and security. Typically, a company will audit a software vendor to review the vendor’s business requirements, functional requirements, system design, requirement
Training/Qualification Record Validation within a Talent Management System
traceability matrix, test scripts, test plan and validation summary report. For any enhancements, the company should also expect the software vendor to send a set of regression test scripts as well as a preview period so the company may review any enhancement to the software, and also serve as an aid for the company’s internal validation effort.
One critical area is 21 CFR Part 11, which defines the rules for acceptability and use of electronic records and signatures in lieu of “paper” records and “handwritten” signatures. Part 11 applies to any record required by FDA in which a company creates, modifies, maintains, archives, retrieves or transmits in electronic form. Part 11 also applies to any record that a company submits to FDA in electronic form (required or not). Key validation requirements include:
•
Audit trails: for example, the system should store key data inputs. date and time stamp, as well as the person who made the change•
System security: for example, system administration should be performed by authorized users who are qualified by documented training and approval•
Electronic signature security•
Code and password security•
Code and password maintenanceTo address these regulatory obligations, Life Science companies typically perform a number of activities for systems that impact the “quality system;” creating the design document, developing user and functional requirements, developing test scripts, and conducting performance testing, among others. The validation effort often gets measured in sunk costs, such as the time needed by salaried IT and validation teams, and also adding many months to the software deployment. For a full-scale TMS that spans the needs of Human Resources, Quality Assurance, Leadership & Development, and individual departments, Life Science companies may question which TMS tools must be validated, based on interaction with the “quality system.”
Most of the TMSs today are designed to meet a wide range of performance and learning needs, and are comprised of a suite of tools that focus on learning, succession management, goals management, performance management and skills development.
To be compliant with FDA regulations, Life Science companies must validate all of the software, databases, spreadsheets and computer systems that impact quality systems. They must also develop the appropriate documentation for all phases of the Software Development Life Cycle (SDLC).
Page 5 Training/Qualification Record Validation within a Talent Management System
Segmenting “Qualification” from “Performance &
Development” Programs
Some validation teams may see a “fine line” that exists between the “Qualification/ Training Record” and the “Skills Development Rating” for an employee. Talent management tools that provide skill gap analysis, for example, may be used to assist Manufacturing or Operational Excellence teams with employee development programs. However, because the “learning system” within the TMS is the record of qualification, this is a system that needs to be “validated” based on FDA requirements.
Any skills development activities that exist simply to enhance employee performance, beyond the baseline qualification, should reside in a non-validated Talent Management System.
Furthermore, HR teams can leverage many aspects of a “Talent Management Suite” to develop leadership programs for managers in the operations or manufacturing production departments, and performance management programs that span all employees. Life Science companies must balance the need to provide development opportunities to employees, to help them develop beyond their current
qualification training, while also maintaining their current qualifications in an auditable format for investigators.
Consider the line operator within a pharmaceutical manufacturing environment. This employee is required to complete several curricula related to his or her job function. These activities, captured in the LMS, should be stored in a validated system. However, the company may decide that any development program designed to assess or measure this employee’s goals or overall performance does not need to be stored in this validated environment.
During a GMP on-site inspection, in which an FDA investigator may ask to review the employee’s qualifications, the auditing team would need to present the documentation and history of qualification.
To accommodate the regulatory investigator’s requests, any qualification training and job function training would need to reside in the platform component that meets 21 CFR Part 11 requirements, while performance management and development activities would reside in a non-validated environment.
A company may decide that any
development program designed to
assess or measure an employee’s
goals or overall performance
does not need to stored within a
validated environment.
Training/Qualification Record Validation within a Talent Management System
A Model for Segmenting Compliance and Talent Management
Applications
To streamline the validation effort, UL EduNeering’s IT and QA experts recommend a model in which a Talent Management Suite of applications are divided between the “Learning and Qualification Record” and the “Performance Management Record” for each employee. This model ensures two outcomes:
1) Audit Accuracy:
Compliance and qualification records are available for audits at any time, while performance management and development activities are not reflected on the employee’s role-based “qualification.” Any records associated with a “developmental” program would not be requested during an external audit by an FDA investigator.2) Reduced Validation Effort:
The talent management tools not related to employee qualification would not need to be validated, eliminating weeks, or even months, of validation and application development effort needed to meet validation requirements; this reduction of effort would accelerate the deployment of the TMS system.Rather than have multiple systems to address the various talent management and compliance training activities, Life Science companies prefer a “holistic” user and administrator experience for all learning and talent management activities. The benefits of relying on a single system are reduced subscription costs, a more convenient one-stop shop employee experience, and reduced administrator training. The model we recommend can deliver these benefits and also encompass both compliance-related and developmental programs. Through a single interface, an employee can complete both compliance-related qualification training, as well as take part in skill development or competency development or performance management programs.
In the UL EduNeering model, the learner can sign into a single application, and “compliance and qualification” training is prescribed to meet baseline qualifications, while “developmental” opportunities and competency ratings are stored in the performance management system. For audit purposes, a single qualification report can be generated to demonstrate that the employee has met his/her training requirements.
When segmented like this, the system validation and change control process must function in a clearly delineated approach, so that any developmental records do not compromise the validated system.
Life Science companies prefer a “holistic” user and administrator experience for all learning and talent management activities. The benefits of relying on a single system are reduced subscription costs, a more convenient one-stop shop employee experience, and reduced administrator training.
Page 7 Training/Qualification Record Validation within a Talent Management System
VALIDATED
“ComplianceWire®”
“Talent Management Suite”
DEVELOPMENTAL
Compliance
Talent
• 21 CFR Part 11
• eSignature
• Role-based Curricula
• Audit Accuracy
• Performance Appraisals
• Competency Management
• Succession Planning
• Analytics & Reporting
BUSINESS DRIVERS
Regulators:
• FDA
• EU
Corporate:
• HR
• C-Suite
• Managers
LEARNERS:
Employees
Contractors
Suppliers
TOOLS
INDIVIDUAL
RATING
%
=
Develop
performance
skills beyond
qualification
=
Qualified
to perform
role
BENEFITS OF A COMBINED SYSTEM:
Single touch-point access to role-based
training data, qualifications & skills
development Regulatory compliant, audit-ready AND HR-Friendly One integrated system for hassle-free
implementation, administration and
Conclusion:
As Life Science companies invest in holistic talent management platforms, they need to consider that employee qualification requirements must follow the strict validation requirements mandated by FDA and EMA. At the same time, the HR and department owners are seeking to provide developmental opportunities to their employees, and these programs can help with talent retention and overall performance improvements.
HR Benefits:
•
Improves accuracy of recruitment activities as they relate to technical skill positions•
Complements any “universal competency” programs in place•
Improves employee retention metrics, as development plansmotivate employees to advance to new skill levels
Manufacturing/Operations Benefits:
•
Improves Operational Efficiency; reduces downtime•
Provides insight into employee skills for resource planning•
Enables more effective skills transfer across employees•
Improves production output and other KPIs•
Helps employee grasp what skills are needed for future positionsQA/Compliance Benefits:
•
Reduces risks of noncompliance•
Helps demonstrate training effectiveness to internal and external auditors•
Makes training more efficient•
Aligns training activities to Critical-to-Quality initiatives The UL EduNeering model can provide Life Science companies with a single solution that can address these benefits, and at the same time reduce the validation effort by segmenting the “developmental” record database of an employee from the “qualification” (and therefore, the validated) database that are part of the quality system.Page 9
TALENT MANAGEMENT... From the Executive Floor
to the Shop Floor.
According to a 2015 Deloitte Bersin report, “performance management is increasingly deemed critical in today’s organizations and historical systems are not perceived as adequately supporting next-generation practices.” To help regulated companies meet both their performance management and compliance learning management goals, UL EduNeering now provides a “Talent Management Suite” within our global ComplianceWire platform.
These tools are designed for HR teams, Talent Management teams, and even individual teams in Operations, Quality, and Sales who manage department-specific goals and skill development programs.
Our Talent Management Suite enables you to standardize your organization’s performance appraisal program across all employees. In addition, tools enable managers to focus on skills development and competencies for each direct report. Our solution will enable your organization to:
• Capture individual performance reviews and appraisals, enabling managers to sign off on each direct report’s review;
• Streamline leadership development programs designed for managers and supervisors;
• Measure “universal” organization competencies;
• Focus on “technical skills & competencies” to expand role-based training programs that improve employee development.
Talent Management Solutions
for Regulated Industries
• Performance Management
• Succession Management
• Goal Management
• Skills Development
• Compliance Features
• Leadership Development
ComplianceWire
®
About UL EduNeering
UL EduNeering is a business line within UL Life & Health’s Business Unit. UL is a premier global independent safety science company that has championed progress for 120 years. Its more than 10,000 professionals are guided by the UL mission to promote safe working and living environments for all people.
UL EduNeering develops technology-driven solutions to help organizations mitigate risks, improve business performance and establish qualification and training programs through a proprietary, cloud-based platform, ComplianceWire®.
For more than 30 years, UL has served corporate and government customers in the Life Science, Health Care, Energy and Industrial sectors. Our global quality and compliance management approach integrates ComplianceWire, training content and advisory services, enabling clients to align learning strategies with their quality and compliance objectives. Since 1999, under a unique partnership with the FDA’s Office of Regulatory Affairs (ORA), UL has provided the online training, documentation tracking and 21 CFR Part 11-validated platform for ORA-U, the FDA’s virtual university. Additionally, UL maintains exclusive partnerships with leading regulatory and industry trade organizations, including AdvaMed, the Drug Information Association, the Personal Care Products Council and the Duke Clinical Research Institute.
