Strict Monitoring
Official specifications, notification requirements, monitoring – regulated industries such as the pharmaceutical industry, medical technology or the food industry are constantly and intensively monitored.
Medical Technology. If medical technology manufacturers in the USA want to export their products, they must fulfill the requirements of the FDA (Food and Drug Administration). The FDA requires, inter alia, that the systems operate with validation. Where this is not the case, manufacturers have to face the consequences, which can extend as far as an import halt.
The Food Industry. Since January 2005, regulation (EC) 178/2002 requires complete traceability for all parties in the food supply chain dealing with food and feeding stuff. This traceability also extends to the materials and objects with which the food comes into contact. Ensuring traceability is the task of the company’s quality management: A prerequisite for this is, among other things, a comprehensive and integrated identification and documentation system.
Pharmaceutical. The pharmaceutical industry is marked by high risks in product development. Development times of up to ten years are the norm and pressure from competition immense. In addition, production facilities are capital-intensive and it is therefore paramount to optimize the degree of utilization.
Meet requirements with IBS Solutions
Quality Management is Mandatory. The revision of ISO/IEC 17025:2005 demands more quality management in laboratories than ever before:
- The regulations concerning test reports have been tightened.
- New requirements regarding proof of qualification.
- Management processes are subject to increased requirements.
- Continuous and effective further development of the quality management system must be attested.
Requirements that can be met with IBS AG’s complete and reliable software solutions.
Legal Validity of Electronic Data. The FDA regulation 21 CFR Part 11 relates to electronic records and electronic signatures. Specific procedures and verifications must be carried out with great precision when compiling, editing saving and transmitting electronic data. Software solutions used in FDA-regulated areas must be able to guarantee the authenticity and integrity of the electronic data. Electronic signatures only become valid once anti-imitation security requirements have been fulfilled and the signatures assume the same validity as those on paper.
IBS Key Benefits for Regulated Industries
IBS Solutions for Regulated Industries
IBS References within this branch
Your contact personGerold Volkmann
Sales Consultant
Phone: +49 (0) 2624 9180-211
Fax: +49 (0) 2624 9180-456
gerold.volkmann@ibs-ag.de
IBS:infopool
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Case Studies
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MAPA - CAQ in the Field of Medical Technology Dateigröße
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CeramTec - Recalls? Out of the question! The interaction of MES and Quality Management has brought about an increase in productivity and optimum traceability at CeramTec AG Dateigröße
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Brochures
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Compliance Management with CompliantPro Dateigröße
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IBS:cockpit Dateigröße
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Function Descriptions
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CAQ=QSYS® Professional WFM Dateigröße
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CAQ=QSYS® Professional Web Edition Dateigröße
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CAQ=QSYS® Professional Traceability Dateigröße
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CAQ=QSYS® Professional Toolcom Dateigröße
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CAQ=QSYS® Professional SPC In-Process Inspection Dateigröße
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CAQ=QSYS® Professional SAM Supplier Assessment Dateigröße
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CAQ=QSYS® Professional Concern and Complaint Management System Dateigröße
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CAQ=QSYS® Professional Personal Reports Dateigröße
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CAQ=QSYS® Professional Quality Main Control Dateigröße
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CAQ=QSYS® Professional Action Management Dateigröße
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CAQ=QSYS® Professional Inspection Plan Management Dateigröße
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CAQ=QSYS® Professional Gage Management Dateigröße
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CAQ=QSYS® Professional Inspection Reports and Certification Dateigröße
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CAQ=QSYS® Professional Netcom Dateigröße
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CAQ=QSYS® Professional Mobile Data Acquisition Dateigröße
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CAQ=QSYS® Professional PH (A) Part History (and Archive) Dateigröße
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CAQ=QSYS® Professional Supplier Portal Dateigröße
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CAQ=QSYS® Professional Graphical Inspection Planning Dateigröße
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CAQ=QSYS® Professional FPM Dateigröße
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CAQ=QSYS® Professional FMEA Dateigröße
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CAQ=QSYS® Professional EMPB Dateigröße
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CAQ=QSYS® Professional Audit Dateigröße
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CAQ=QSYS® Professional APQP and Control Plan Dateigröße
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