Advantages of a Quality Management Software for the Pharmaceutical Industry


The pandemic has put the pharmaceutical industry under a microscope. The pressure to rapidly manufacture and quickly bring medications to the market is bigger than ever, and pharma companies need an effective way to manage this stress while staying ahead of the competition. If you are in this industry, a tailored QMS software system can help your organization stay on top of all quality-oriented processes.

Better control

A quality management system makes it easier to control every stage of the manufacturing process, from choosing which raw materials to use, to creating the final product. If you can manage things from start to finish, there is less of a chance that you will experience problems down the line that would require going back and starting again at square one.

Deviation management

Companies that fall under regulated sectors (including pharmaceuticals, biotechnology, medical devices, and diagnostics) are required by the FDA and ISO to document and receive approval for any deviations. Such deviations can happen at any stage of the process, from raw material acceptance to distribution.

Going against the procedures set in place for your document management system can have negative consequences on quality, which then directly impacts regulatory compliance. While it's impossible to eliminate deviations altogether, pharmaceutical companies can use QMS software systems to monitor both expected and unplanned variations.

Compliance with industry standards

The pharmaceutical industry requires strict quality control measures to ensure that all medical supplies are compliant with regulatory standards. QMS software systems

help you verify that products meet the required quality standards of relevant regulatory committees.

Vendor management

Pharmaceutical companies must take measures to prevent supplier materials that do not meet specifications from being used in production.

High-quality QMS software systems provide the tools you need to comply with various standards, such as ISO 9001 section 8.4 and ISO 13485 Section 7.4.3. It allows you to customize vendor audit templates, status, and scorecards while reminding you when it is time to review a vendor.

CAPA management

Comprehensive QMS software systems have CAPA (Corrective and Preventive Action) modules that help your organization proceed with appropriate actions for the nonconformance issues recorded. These modules assist pharmaceutical companies in driving continuous improvement by directing employees through a process that enables them to identify, anticipate, and correct any nonconformances that might stop the company from meeting customer requirements. This is all done while taking into account the potential introduction of new risks.

The best QMS software: Total Lean Management

Pharmaceutical organizations need to invest in a quality management system to streamline quality processes, document procedures, inspect materials, implement corrective measures and ensure compliance with regulatory standards. Total Lean Management (TLM) is one of the best products for this purpose.

TLM is the first quality management software to offer distinct applications for each user group, rather than a one-size-fits-all approach. This not only makes everyone's experience more efficient but also reduces wastefulness in the QMS overall, thereby helping companies of any size achieve a state of active connection between their QMS and people, processes, and prosperity.

TLM is a comprehensive solution that can save you from buying separate software for each element of your QMS. It also allows easy integration with other systems when needed.

TLM has two decades of experience helping businesses like yours to grow by utilizing ISO- and FDA-required quality management system processes. Our software is quickly adaptable to your unique needs because we understand that every business is different. Our system settings, custom fields, and development project support make continual customization easy so that your company's improvement efforts are always supported.

Request a demo to see how it works.


Location: United States

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