How is GCube’s Pharma LMS 21 CFR Part 11 Compliant for Audit Trail Management?

Our clients in the USA, have complained of sleepless nights due to the fear of receiving FDA 483 letters. So, even before we start the conversation, we understand your pain. As many as 429 organizations have received warnings from the FDA for non-compliance related to creating or following SOPs and problems with record keeping. In our endeavor to build a pharmaceutical specific LMS, GCube has built a learning solution that not only manages your audit trails and learner records effectively but is also in compliance with 21CFRPart11 guidelines.

In our analysis of the problem of FDA fines pertaining to audit trail management that we were trying to solve for our pharma clients, the few major challenges that came up in our scrutiny were as follows.

Manual Management

The audit trails and learner records are usually maintained on excel which of course is does not suffice when the scale of the records that needs to be maintained grows. The traditional practice of paper-based record keeping is also discarded due to the inefficiency and manual errors that is kind of obvious. As this practice made audits a tedious process due to lack of data availability, the FDA mandated e-record keeping and e-signatures.

Secured System

In a real-life situation, a big Pharma company’s drug got cancelled because an official mistakenly put a backdated signature on a document. The lack of a secured system that does not allow any backdated activity and maintains a rigid audit trail for the authorities is a necessity to avoid any situation that may lead to a compliance failure.

Huge MIS

Auditing happens of not only procedures but for each job role related to the procedure, training, process documents, hardware and software, external agencies, changes, and modifications in the process. It is herculean a task, to even visualize the gigantic amount of data that has to be tracked and monitored to avoid issues with the authorities.

We have solved these challenges with customization of the GCube learning management system and here’s how.

•  The QMS and DMS are integrated with the LMS to create a single repository of processes, documents and training related to the same.
• All the records in the system are validated; no invalid record is stored in the data stores (Database, Files etc.) even temporarily. Any invalid input is rejected, and system asks user to re-enter the valid input.
• A combination of login code and password is used as e-signature at all the instances. To every record which is added to the system, the id of user who has added the record is maintained. This id is linked to the user account profile which contains its login code and digital signatures.
• Every change in the system – addition, modification or deletion of the entity is tracked in respective audit trail. These audits are non-modifiable and cannot be deleted, however can be archived by the authorized users.

• The records once added can be updated or deleted only by authorized users. No one else can access the record for any modification. The system also limits the access to feature(s) only to the valid users. Only the authorized users are to view screen and modify the authorized objects.
• An approval process is there before finalizing the learning objects, hence, maintains sanity of the data. For ready retrieval of data, there are multiple standard reports and custom reports.
  
  

With our 20+ years of industry experience, R&D at GCube is always client-centric and practical. With a host of industry specific customization, our Pharma LMS has helped multiple clients from the industry avoid multiple training challenges, including non-compliance.

To know more about our solutions, please write to us at in**@gc**********.net.