A Warehouse Management System to Regulatory Compliance 21 CFR Part 11

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Warehouse systems provide the tools for ensuring the quality of inventory and product services in an organization, such as shipment, receiving, inventory control, product design, staff, etc.

The application of a warehouse management system in pharma industry has the potential to revolutionize the operation of a business and agency.

Getting the correct technologies in place is an important aspect of the supply chain of a pharmacy company and is vital to the performance of corporate operations as a whole.

Reasonable software simplifies material handling through automation, while maintaining effective supervision and monitoring at all warehouse management stages, and meeting clear regulatory and administrative specifications for the pharmaceutical industry.

Besides, the warehouse consistency is crucial for the functioning of the system and, to achieve so, data must be entered correctly and promptly.

Warehouse Management System in Pharmacy

A WMS is always difficult to enforce. Planning is important for the application of WMS to progress. The project needs warehouse personnel to gather data on the actual facility, equipment, and product, as well as to identify operational strategies. The application of the warehouse management system in pharma industry can minimize labor costs in the placing and removal of supplies.

It seems extra difficult to include a system when the warehouse already is in operation. Even delivering goods as the WMS is being applied is a big consideration.

In this scenario, the issues include the inability to create an effective warehouse structure that is ideally tailored to the products being managed, on-the-spot procurement expertise and staff planning and training.

Adherence to the compliance made easy

While a successful implementation of WMS assures the proper adherence to regulatory compliance 21 CFR Part 11.

Part 11 points out how an organization should use online compliance documents and digital signatures to comply with FDA regulations instead of paper-based reports and ‘wet signatures.’

Fundamentally, it serves as a legislative solution to security issues over handling the distribution, storage, and retrieval of information by suppliers of biotechnology, medicines, and medical devices.

Nevertheless, it was also meant to undertake the enormous expense of retaining paper-based documentation for such businesses to satisfy the regulator. Essentially, a core goal of the law was to enable such businesses to move to information systems.

In the case of pharmacy, it is important to decide how to approach FDA 21 CFR Part 11 compliance for the control of audits, system validation, audit trails, eSignatures, and software documentation.

The sophisticated WMS can simplify compliance with all requirements of regulatory compliance 21 CFR Part 11 such as system implementation, electronic records keeping, and electronic signatures.

Moreover, this program will simplify FDA criteria for a risk-based approach to validation and revalidation.

And the system is compatible with significant improvements that are made by providing periodic updates according to changing regulations.


Paper-based records require considerably more time, cash, human resource, and other tools. Besides, they’re subjected to loss and might get damaged. While a WMS ensures safety from all these concerns while making operations easy.

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