Jun 22, 2021

In a previous post, we examined how robust learning management system (LMS) capabilities can effectively support life sciences companies’ quality and risk management processes as well as ensure adequate employee training and compliance.

For pharmaceutical, medical device and biologic product manufacturers seeking to implement third-party LMS tools, careful evaluation of each vendor’s system features and capabilities is necessary to ensure that firms’ specific compliance, conformity and training requirements are properly supported. Companies taking a more strategic view of LMS functions—that is, leveraging LMS tools as a competitive differentiator in terms of quality assurance, risk mitigation, market entry and compliance—should employ thorough due diligence before undertaking LMS implementation projects. Below, we discuss five key features life science companies should look for in third-party LMS offerings.

Assignment-based training

First, an LMS software package suitable for life science companies should feature tools enabling training managers and supervisors to set and assign group memberships according to their own definitions of role-based qualification groups. Assignment-based training functionality corresponds to the US Food and Drug Administration’s regulation 21 CFR Part 211.25 and 21 CFR Part 820.25 regarding training necessary for personnel to perform their jobs correctly.

These tools should include features such as time-stamping to safeguard training records and demonstrate compliance to US FDA 21 CFR Part 11 regarding electronic records and signatures.

Audit trail support for critical assignments

Second, any viable LMS product for life sciences industry applications should support secure audit trails that capture data such as dates and times of actions that create, change or delete any electronic records.

LMS administrators should be able to access and view electronic logs of events such as assignment additions or changes, or changes to individual users’ security roles.

Flexible security roles

Third, an LMS should provide for flexibility in terms of defining and designating security roles. System administrators must be able to define and assign security roles for performing system changes, adding or updating training modules and other functions. Tools to limit security roles to specific individuals within life sciences companies are also crucial for an effective LMS process.

Electronic signatures for SOPs and assessments

Under 21 CFR Part 11, electronic signatures must be linked to corresponding electronic records to prevent falsification or inappropriate transferring or copying of such signatures. Appropriate signer information—printed name, date and time of signing and other user identification—must also be linked to electronic signatures.

Real-time reporting capabilities

In addition, an LMS should provide companies with the tools to determine whether their training programs are effective; accordingly, system administrators require the ability to generate training analysis reports from their LMSs to evaluate such effectiveness.

Training analysis reports should convey several important components:

  • Details on employee orientation training regarding relevant Good Manufacturing Practice (GMP) or quality management system (QMS) regulations and requirements;
  • Documentation of work practices conducted to identify necessary job tasks and operations;
  • Demonstrations of employee retraining on standard operating procedures (SOP) following modifications or corrective actions;
  • Documentation showing all training assigned to individual employees as well as the status of each training requirement.

Given these and related reporting requirements, companies should assess third-party LMS products in terms of generation, customization and distribution of training analysis reports to fine-tune and optimize training programs.

Life science companies should approach their LMS implementation projects with these as well as additional criteria in mind to ensure training and compliance capabilities that best reflect their commercialization, quality assurance and risk management goals.

Mike Lawrence is Head of ComplianceWire Product Management at UL.

Learn more about LMS technologies to support the life sciences industry

  • UL ComplianceWire® LMS support for life sciences companies and manufacturers

 

Author

  • Mike Lawrence and Stewart Eisenhart

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