The importance of a Pharmaceutical LMS in Audit Trail management

Audit Trail Management is a regulatory requirement in the pharmaceutical industry. An audit trail is essential because it makes electronic data secure and traceable. It helps in keeping track of the name of persons who accessed the computer system with the date and time. It also helps in recovering the lost data. The audit trail maintains the integrity and security of audit records and a pharmaceutical LMS has a role to play here.

FDA has issued numerous warning letters pertaining to audit trails. In pharma manufacturing, the requirements and conditions of the audit trail impact computer-controlled systems. Audit trail management must be performed for all equipment, procedures, and people training in the pharma industry.

Only when these computerized systems do not have the option of data change, audit trail management is not a necessity. But systems like these must be controlled through SOPs which ensure authorized access to the computerized system.

Challenges in Pharma Audit Trail management

Audit Trail Management faces various challenges in the pharmaceutical industry. Many pharma companies rely on manual management wherein records are usually maintained on excel which is not scalable. The FDA has also mandated e-record keeping and e-signatures and discarded the traditional practice of paper-based record keeping because of the inefficiency and manual errors.

Another challenge faced by pharma companies in audit trail management is the lack of a secured system that does not allow any backdated activity and maintains a rigid audit trail for the authorities. Something as seemingly small as putting a backdated signature on a document can lead to compliance failure and huge losses and business risks.

A pharma audit doesn’t just happen for procedures. It happens for each job role related to the procedure, training, process documents, hardware and software, external agencies, changes, and modifications in the process. So, in order to maintain compliance an enormous amount of data has to be tracked and monitored to avoid issues with the authorities.

Importance of a Pharmaceutical LMS in Audit Trail management

A pharmaceutical LMS ensures seamless audit trail management with automated tracking and record-keeping. Automated record-keeping significantly eliminates errors and enhances efficiency. Here are a few essential features of a pharmaceutical LMS that simplify audit trail management for companies:

1. Continuous Tracking

A pharmaceutical LMS ensures continuous tracking of every aspect that will be audited. This ensures a gapless audit trail management which reduces the risk of compliance failure.

2. Data Storage Capabilities

Apart from continuous tracking, a pharma-industry-specific LMS also has amazing data storage capabilities. This makes sure that you don’t have to worry about tracking and storing an enormous amount of data.

3. Secure System

A pharmaceutical LMS only takes valid inputs. No invalid record is stored even temporarily. This includes backdated signatures. This maintains the security of the system.

4. Centralized Data

A pharmaceutical LMS keeps the data centralized which simplifies management. The QMS and DMS are integrated with the LMS to create a single repository of processes, documents, and training related to the same.

5. Custom Report Delivery

The audit trail that is demanded by the auditors has a specified format. A pharma LMS helps you deliver your records in the format specified by authorities with the custom report delivery feature.

To sum up, a pharmaceutical LMS offers various features that simplify audit trail management. With rigid and strict regulations about audit trail management in the pharma industry, a pharma industry-specific LMS is the right choice.

With 20+ years of experience in the learning industry, GCube is focused on creating customer-centric solutions by identifying issues of the industry. We would love to talk to you more about our solutions and products. Do write to us.