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AlisQI recognized for the second consecutive year as a Representative Vendor in the 2024 Gartner® Market Guide for Quality Management System Software Report Read the full story Introduction AlisQI Get the bird’s eye view on the AlisQI platform and the pains it helps solve. This 2-min video...
All our auditors are full-time UL Solutions employees providing consistent audit experiences and support throughout the life of your QMS. With UL Solutions as a trusted partner and our worldwide network of technical medical device experts, we help you innovate and navigate complex regulatory requirem...
Sync related Complaint data into MedWatch 3500A Form and automatically trigger electronic eSubmissions to FDA ESG with full audit traceability. eIFU Achieve electronic instructions for use (eIFU) compliance related to EU and FDA regulations, such as MEDDEV 2.14/3 and MDR Regulation (EU) 2017/745...
CQ EQMS allows supply chain partners to be involved in the process, thus bringing full visibility to quality information across the supply chain. Offering configurable workflows, user interface design and object design, the solution can be easily scaled to fit the needs of different organizations ...
核心任职要求: 1.具有制造工厂或集团级QMS产品设计或项目实施经验,可独立完成需求调研与蓝图设计,了解项目交付流程; 2、精通APkanzhunQP、MSA、PPAP、FEMA、SPC五大质量工具; 3、精通ISO9001/IATF16949质量管理体系、熟悉制造企业质量体系建设与实施,熟悉来料质量、制程质量、品质检验等业务流程; 4、熟悉智能制造(MOM...
Comprehensive, AI-powered with full mobile access and enterprise-level security and customization. Schedule a Call How it Works 1. Get Ready To Pass Audits, Stress-Free Create customized controls, forms, workflows, procedures, documents, and compliance artifacts that are quick to complete, track an...
Full account should be taken of regulatory requirements. Page 16 of 73 APIC / CEFIC Quality Management System - integrating GMP (ICH Q7a) into ISO (9001: 2000) Page 17 of 73 4. Product Realization (Manufacturing Operations) This section relates to ISO 9001: 2000 chapter 7 The product ...
If a form is not handled in a timely manner, the system can be set to escalate the issue. Data Sheet MasterControl Deviation Enhanced Forms MasterControl deviations management systems are designed with quality compliance in mind. By providing secure, time-stamped audit trails, full reporting ...
Focusing Solely on Compliance:Limiting the gap analysis to compliance requirements without considering process efficiency, customer needs, and organizational goals can hinder the full potential of the QMS improvement. Neglecting Future Needs:A good gap analysis should not only address the current issues ...