Traditionally, a paper-based system has been used in pharmaceutical organizations for documenting all training completions. But as organizations grow in size and geographical spread, they have to switch to computerized systems to maintain efficiency. The paper-based system fails to deliver in bigger organizations for many reasons. Firstly, the sheer bulk of the records to be maintained causes inefficiencies in the system. It also makes audits difficult and tedious, which in turn causes further failings of the system.
However, the FDA (Food and Drug Administration) has mandated that Pharmaceutical Industry need to implement those systems which comply with Title 21 CFR Part 11 of the Code of Federal Regulations. This regulation specifies the FDA guidelines on electronic records and electronic signatures in the United States. Part 11, as it is commonly called, defines the criteria under which electronic records and electronic signatures are considered to be trustworthy, reliable and equivalent to paper records.
The systems implemented in the industry must also follow three protocols called IQ, OQ, and PQ. IQ stands for “Installation Qualification.” The IQ records the installation of the software and ensures that the installation follows the correct steps. OQ stands for “Operational Qualification.” The OQ tests or qualifies that the solution is working using test data in general. PQ stands for “Performance Qualification,” which means that the application, under real-life conditions, consistently produces products which meet all predetermined requirements.
Precautions while Selecting an LMS/Vendor
While there are several Learning management Systems available in the market, only a few can help pharmaceutical companies to comply with Title 21 CFR Part 11and IP/OQ/PQ protocols. If the system does not maintain these compliances, FDA can impose serious penalties on the organizations.
Organizations must ensure that they partner with those LMS vendors which have significant experience in implementing LMS for Pharmaceutical companies. The vendor and the system must have already undergone several audits on Title 21 CFR Part 11and IP/OQ/PQ protocols. G-Cube has successfully implemented its WiZDOM LMS for several pharmaceutical companies in India.
Benefits of Learning Management Systems
Apart from maintaining compliance, a Learning Management System (LMS) based solution can prove to be extremely efficient to deal with the training requirements of the industry.
- Notifications and reminders can be automatically sent through emails or SMSs as soon as a trainee has been assigned a course. The frequency of these notifications can be customized as per need.
- Gap analysis of required and completed training for all trainees can be conducted to assign training as per job descriptions. The LMS can be customized to conduct the analysis on a continuous basis or from time to time.
- Rapid authoring tools can facilitate the creation of e-courses on short notice, allowing the repository of available documents to grow rapidly. Updates and changes can also be made on these courses very easily, using the same tools.
- Changes in training material (for instance SOPs) can automatically trigger a training alert to learners who need to be trained on the revised courses.
- Reports of training planned and completed for each employee are available at all times, easing the audit process.
- Online assessments for courses can be conducted with the help of quizzes and tests with randomized questions. Records of these evaluations are available at all times for audit purposes
The Training Management System not only helps organizations comply with mandatory trainings but also helps in increasing the efficiency of the workforce and achieving excellence in product quality.