Pharmaceutical, Biotech and Medical Device Manufacturers. Be Compliant and Audit Ready - Implement an LMS!

Transcription

1 Pharmaceutical, Biotech and Medical Device Manufacturers Be Compliant and Audit Ready - Implement an LMS!

2 Organizations in the life sciences industry such as pharmaceuticals, medical devices and biotech companies have stringent training and compliance requirements. These companies must comply with U.S. Food and Drug Administration (FDA) quality system standards to ensure that all products are produced in a controlled and safe manner. Training records are a key component of showing that employees are able to deliver quality products that are aligned with quality standards. The regulatory pressures facing life science companies are monumental, and the costs of noncompliance, threatens production output, brand reputation, and long-term growth. Managing compliance initiatives can be expensive and time consuming. Compliance can be tracked manually, but manual tracking is time consuming and error prone. (860) State Street, Suite 400, New London, CT

3 Investing strategically in areas such as training and technology helps to minimize regulatory impact. Investing in learning management system (LMS) technology makes it easier than ever before for you to automate and manage your training initiatives while conforming to regulatory requirements, including 21 CFR Part 11. What can an LMS do for you? Provide proof that your organization is tracking what an employee must know to perform his/her job correctly. Ensure that updates and additions to required training are immediately made known to impacted learners via their learner profile and through notifications. Confirm that your employees took the required version of training within the specified timeframe, while providing complete traceability through well-managed and documented training records. Gives your organization the confidence to know that your training records are up-to-date and inspection-ready.

4 However, not all LMSs are created equal. LMSs created for general professional development may not have the functionality to meet all of your regulatory learning requirements. The Food and Drug Administration (FDA) mandates that all life sciences organizations ensure the authenticity of electronic records and signatures, including training records. 21 CFR Part 11 requires controls including audits, system validations, and electronic signatures and documentation for software and systems involved in processing electronic data, such as LMSs. Therefore, LMSs must be validated to ensure accuracy, reliability, consistent intended performance, and the ability to discern invalid or altered records. It s extremely important that organizations partner with a LMS vendor that conforms with 21 CFR Part 11 and that have experience working with regulated companies. (860) State Street, Suite 400, New London, CT

5 epath Learning, Inc. is an ideal partner for those regulated organizations seeking comprehensive online training and compliance solutions. Our cloud-based learning management technology, epath Learning s ASAP LMS, conforms to 21 CFR Part 11 while helping you to securely manage your employee training and compliance initiatives from start to finish. epath Learning ASAP LMS System Highlights: Deliver, Manage and Track Employee Training for Compliance ASAP lets you create or import training courses and materials, assign, administer, track and report on your training and compliance efforts. Our cloud-based technology is easily accessible via the Internet so your employees can access their training materials from anywhere, anytime day or night, and from desktop or mobile devices. Learner training records are easily retrieved including the versions of the courses they ve completed, when the courses were completed, and associated quiz or exam scores, to name a few reporting options.

6 Course Content and Document Control ASAP s powerful authoring tool lets your designated team members create, modify and archive engaging elearning courses. Existing PowerPoint presentations can be converted quickly into elearning courses or you can use the authoring tool to develop content from scratch. ASAP is also content neutral; therefore, you can launch any AICC or SCORM compliant course materials. Self-checks, quizzes, tests and assessments are easily configured to test your employees competency, identify skills gaps or assess feedback. Support documentation, such as SOPs, can be uploaded and stored in the system and accessed with read and acknowledge or esignature stipulations. ASAP supports version control and maintains a time-stamped audit trail of all changes made to your materials and interactions within the system. (860) State Street, Suite 400, New London, CT

7 Assign Training Based on Employee Needs Administering training based on employee job type or role ensures that your team receives just the content they need when they need it. Learning paths are easily developed that guide your employees through their development. You can schedule annual training requirements and deliver alerts to remind employees of upcoming training events and expected due dates. You can even schedule, track and report on blended learning events including instructor-led training, webinars or required reading materials. In some organizations, as much as 70% of learning, as measured by workers hours, is dedicated to training or retraining employees on topics defined by mandated regulatory courses Elliott Masie Chairman and CLO Masie Center s Learning Consortium 1 Compliance, Learning and Seat Belts, August 25, 2014, Chief Learning Officer Magazine

8 epath Learning ASAP Technical Requirements Overview: 21CFR Part 11 Verification Electronic signatures Access Control and Encryption Authentication is based on user ID, password and organization code. Authorization is based on roles and access permission lists. SSL network encryption Symmetrical strong data encryption for passwords. Client data is isolated by University. Learner history is not accessible directly and is updated based on actions by the learner or an authorized action by an administrator. Audit Trails All actions related to the learner s history are audited. The audit trail cannot be changed by learners or administrators Each event has a system generated time stamp. Reports provide detailed description of learners history transactions and the origin of the data. The data in the reports cannot be changed by users. Database Integrity and Abstraction Application Validation and Staff Training The database cannot be accessed directly by users. The system employs an Oracle database and supports full RDBMS ACID compliant transactions. Regular security orientation and training of technical and engineering staff. Ongoing validation of software releases and software updates against a comprehensive test plan. Regular vulnerability assessments and penetration tests of core functions to ensure each function is performing as expected. Peer reviews of critical system functions to ensure adherence to proper authentication, authorization and encryption controls. Dedicated QA team to ensure proper accountability and test results.

9 Well-managed training programs minimize the risk of noncompliance and ultimately helps to improve your product/service quality. Implementing a LMS helps you to manage compliance training effectively. With epath Learning s ASAP LMS, electronic records are updated in real time for comprehensive compliance reporting. Reports are quickly and easily accessible, enabling your organization to be audit ready in a flash! ASAP supports auditing, e-signatures, version control and reporting to conform with 21 CFR Part 11 compliance requirements for electronic records. Would you like to learn more about how implementing LMS technology can benefit your company? Perhaps you d like to see a live demonstration of our LMS platform? Feel free to contact us at , via [email protected], or visit our website at (860) State Street, Suite 400, New London, CT