Solution: Quality Management for Pharmaceuticals and Medicine<\/p>\n\n\n\n
Quality management in the regulated industry with enaio\u00ae<\/h1>\n\n\n\nAll regulations and guidelines in view at all times<\/h2>\n<\/div>\n<\/div>\n<\/div>\n\n\n\n\nQualit\u00e4tsmanagementsysteme (QMS) geh\u00f6ren zu den wichtigsten Faktoren langfristigen Unternehmenserfolges.<\/p>\n\n\n\n
Quality is the key word in production. Companies in all branches of industry have to define and guarantee the quality of their products and their actions for different reasons.<\/p>\n\n\n\n
Laws, regulations, standards, official specifications and customer requirements clearly describe what needs to be observed. Companies describe the degree of quality and how it is created and controlled in a large number of documents. The management of these documents is a major challenge for those responsible.<\/p>\n<\/div>\n\n\n\n
\n![\"enaio](\"https:\/\/www.optimal-systems.de\/wp-content\/uploads\/2024\/01\/infografik-enaio-qms-suite-uebersicht-1024x569.webp\")
Quality management in the regulated industry with enaio\u00ae <\/strong>
Overview of the variety of solutions within the QMS suite<\/figcaption><\/figure>\n<\/div>\n<\/div>\n<\/div>\n\n\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t<\/div>\n\n\nHolistic<\/h3>\n\n\n\n
Manage documents in a uniform platform without media disruptions<\/p>\n<\/div>\n\n\n\n
\nIndividual<\/h3>\n\n\n\n
Applications \u2013 only the ones you need and exactly how you need them<\/p>\n<\/div>\n\n\n\n
\nInteroperable<\/h3>\n\n\n\n
Manufacturer-neutral (can be integrated into HIS<\/a>, Office<\/a>, ERP<\/a>, specialist applications)\/ IHE-compliant<\/p>\n<\/div>\n<\/div>\n<\/div>\n\n\n\n\nTrust is good. A flexible ECM is better.<\/h2>\n\n\n\nSustainable quality management in the pharmaceutical industry<\/h3>\n\n\n\n
Quality management in the \u201cregulated industry\u201d is subject to special regulations. Drug safety, SOP management (controlled QM documents<\/a>), customer complaint, change management<\/a>, GxP and much more are closely monitored by the authorities. All production processes must be documented in a comprehensible manner (batch recording). All events related to the quality of the product must be recorded, analyzed and evaluated (incident management and change management). Deviations must be documented (deviation management<\/a>) and errors eliminated and avoided in the long term (CAPA processes). If necessary, the effects must be reported to the authorities (vigilance).<\/p>\n<\/div>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n- <\/span>
General document management<\/p><\/span><\/li>\n\n\n\n
- <\/span>
Connection to specialist procedures in public administration<\/p><\/span><\/li>\n\n\n\n
- <\/span>
Process support through digital workflows<\/a><\/p><\/span><\/li>\n\n\n\n- <\/span>
Qualit\u00e4tsmanagementsysteme (QMS) geh\u00f6ren zu den wichtigsten Faktoren langfristigen Unternehmenserfolges.<\/p>\n\n\n\n
Quality is the key word in production. Companies in all branches of industry have to define and guarantee the quality of their products and their actions for different reasons.<\/p>\n\n\n\n
Laws, regulations, standards, official specifications and customer requirements clearly describe what needs to be observed. Companies describe the degree of quality and how it is created and controlled in a large number of documents. The management of these documents is a major challenge for those responsible.<\/p>\n<\/div>\n\n\n\n
Overview of the variety of solutions within the QMS suite<\/figcaption><\/figure>\n<\/div>\n<\/div>\n<\/div>\n\n
Holistic<\/h3>\n\n\n\n
Manage documents in a uniform platform without media disruptions<\/p>\n<\/div>\n\n\n\n
Individual<\/h3>\n\n\n\n
Applications \u2013 only the ones you need and exactly how you need them<\/p>\n<\/div>\n\n\n\n
Interoperable<\/h3>\n\n\n\n
Manufacturer-neutral (can be integrated into HIS<\/a>, Office<\/a>, ERP<\/a>, specialist applications)\/ IHE-compliant<\/p>\n<\/div>\n<\/div>\n<\/div>\n\n Quality management in the \u201cregulated industry\u201d is subject to special regulations. Drug safety, SOP management (controlled QM documents<\/a>), customer complaint, change management<\/a>, GxP and much more are closely monitored by the authorities. All production processes must be documented in a comprehensible manner (batch recording). All events related to the quality of the product must be recorded, analyzed and evaluated (incident management and change management). Deviations must be documented (deviation management<\/a>) and errors eliminated and avoided in the long term (CAPA processes). If necessary, the effects must be reported to the authorities (vigilance).<\/p>\n<\/div>\n\n\n\n General document management<\/p><\/span><\/li>\n\n\n\n Connection to specialist procedures in public administration<\/p><\/span><\/li>\n\n\n\n Process support through digital workflows<\/a><\/p><\/span><\/li>\n\n\n\nTrust is good. A flexible ECM is better.<\/h2>\n\n\n\n
Sustainable quality management in the pharmaceutical industry<\/h3>\n\n\n\n
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