For those enterprise organizations out there, Enterprise Quality Management Software
(EQMS) has now become something of the status quo. This is because the right EQMS has the potential to increase the bottom line by ensuring fewer errors, better customer satisfaction, improved product quality, and an overall better valuation of the brand.
Tools like the EQMS platform from ETQ are made for this purpose and so are worth the high initial investment. Whilst this platform provides a rounded solution, this is not always the case which is why enterprise businesses need to understand what features are indispensable and which ones are not.
Every single enterprise organization that operates within an FDA-regulated industry is required, at any moment in time, to pass an external audit. The process of thinking about compliance should be done when looking into EQMS solutions. Having the right system in place can make staying compliant so much easier through the implementation of compliant data handling, training, esignatures, and document management. Having the wrong type of system, one that does not control these processes, can be a huge risk to an FDA-regulated business, and this situation should be avoided at all costs.
Where an enterprise organization is growing quickly, it requires an EQMS that has process flexibility. Upon reaching market approval, an enterprise organization’s system will need to be able to scale from pre-market capabilities like training and document management to integrating new workflows and features, such as Corrective and Preventative Actions (CAPA). This is why a system must contain options to be able to instantly integrate systems and processes.
An EQMS should fit an enterprise organization’s current processes without great adjustment and provide the flexibility to both change and scale as the business grows and processes improve. The true measure of flexibility is in the amount of value that can be derived from it straight away and how quickly and effectively it is able to change with the business. An effective system should have a drag and drop editing capability to update checklists, templates, forms, and workflows.
Those enterprise organizations operating within the medical device, biologics, and pharma industries are required to meet certain requirements as far as their reporting is concerned. This includes keeping audit trails, record keeping, and access control for sensitive data. To achieve these things, an EQMS is required that has closed-loop reporting capabilities. As well as meeting the required legislation, it also generates real business value.
The right EQMS will provide value for an enterprise organization straight away by delivering impact across reporting, culture, and procedures, without the need for a huge amount of configuration. The right system should be put in place procedurally, used behaviourally, and measured controllably. When implementing a system it is important to ensure that it fits with the business reporting, people, and process needs.
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Disclaimer: The information provided on the website is only for informational purposes and is not intended to, constitute legal advice, instead of all information, content, and other available materials.