An AI-powered platform for PLM, QMS, EHS, and SRM. Streamline product, quality, safety, and supplier management with a unified, next-generation, cloud-based solution.
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Creating Effective SOP Training Programs in Regulated EnvironmentsIntroduction Standard Operating Procedures (SOPs) are the backbone of regulated operations—from manufacturing to clinical labs. Turning SOPs into engaging, traceable training programs requires the right Training Management Software. 1. SOP Training Essentials in Regulated Industries SOPs must be version‑controlled and approved. Staff need to train on each applicable SOP, often...0 Commenti 0 condivisioni 100 Views 0 AnteprimaEffettua l'accesso per mettere mi piace, condividere e commentare!
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Managing Approved Supplier Lists (ASLs) with Smart SoftwareImportance of Approved Supplier Lists An accurate Approved Supplier List (ASL) is essential for quality control, procurement efficiency, and regulatory compliance. Supplier Management Software eliminates errors and outdated entries through automated ASL management. Common Issues with ASL Management Duplicate or outdated supplier records Lack of visibility across departments...0 Commenti 0 condivisioni 168 Views 0 Anteprima
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Aligning Change Management with CAPA and NC TrackingIntroduction Organizations face constant changes due to nonconformances (NCs) and corrective actions (CAPA). Aligning change management with these processes is crucial for maintaining quality and compliance. Why Integration is Essential When Change Management Software integrates with CAPA and NC tracking, it ensures every change is linked to its root cause and corrective measures....0 Commenti 0 condivisioni 146 Views 0 Anteprima
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How Document Management Systems Help with EU MDR and IVDR Documentation1. Introduction The EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) present stringent documentation expectations. A modern Document Management Software is essential for managing technical files, risk assessments, validation documents, and post‑market surveillance artifacts, especially in the context of Document Management, document version control software, and...0 Commenti 0 condivisioni 94 Views 0 Anteprima
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Role-Based Compliance Training in Regulated EnvironmentsIntroduction In regulated industries such as pharmaceuticals, medical devices, and automotive, different roles require specific compliance training. Implementing Training Management Software alongside DMS software with role-based training ensures that employees receive the right knowledge tailored to their responsibilities while maintaining secure document control and audit readiness....0 Commenti 0 condivisioni 469 Views 0 Anteprima
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Managing Regulatory Audits with Real-Time Supplier DocumentationIntroduction Regulatory audits are often a source of stress for compliance and quality teams. However, with the right Supplier Management Software, audits become more manageable—even predictable. Centralizing supplier data and integrating with supplier relationship management software ensures you're always audit-ready. Why Real-Time Supplier Documentation Matters Minimizes downtime...0 Commenti 0 condivisioni 450 Views 0 Anteprima
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Change Management for ISO 13485 and ISO 9001 ComplianceIntroduction ISO standards such as ISO 13485 (medical devices) and ISO 9001 (quality management systems) require robust change control procedures. Without a proper system in place, organizations risk non-compliance, product recalls, and operational inefficiencies. Change Management Software ensures your processes are structured, compliant, and auditable. Requirements from ISO Standards...0 Commenti 0 condivisioni 444 Views 0 Anteprima
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Automating Audit Trails with Cloud-Based DMS for Life SciencesIntroduction Audit trails are a foundational requirement for regulatory compliance in life sciences. Cloud-based Document Management Software ensures these trails are automated, accurate, and tamper-proof. 1. Importance of Audit Trails Audit trails record all actions taken on documents—who accessed, edited, or approved a document and when. This transparency is essential...0 Commenti 0 condivisioni 517 Views 0 Anteprima
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