• Webinar: Beyond Annual Reviews - Building a Culture of Continuous Growth. Register Now.

  • Streamline Quality Management
  • GxP Compliance
  • QMS & Med. Compliance
  • GxP Training
  • Resources
  • Why eLeaP
  • Blog
  • Learning Management (LMS)

Blog

Unlocking Excellence: Quality at the Core

  • QMS

    17 articles

  • QMS

    11 articles

  • 21 CFR Part 11

    9 articles

  • Pharmaceutical Manufacturing

    7 articles

  • Compliance Culture

    6 articles

  • Aviation Industry

    6 articles

  • Quality Management System Software

    6 articles

  • Medical Devices

    5 articles

  • Quality Management Systems

    5 articles

  • cGMP Guidelines

    4 articles

  • FDA Inspections

    4 articles

  • Change Control

    4 articles

  • Laboratory Quality Control

    4 articles

  • Quality

    3 articles

  • Clinical Evaluation

    3 articles

  • Audit Management

    3 articles

  • CAPA

    3 articles

  • ISO

    3 articles

  • Quality Control

    2 articles

  • ISO 13485

    2 articles

  • ICH E6 R3

    2 articles

  • Uncategorized

    2 articles

  • FDA

    2 articles

  • ISO 14971

    2 articles

  • Supply Chain

    2 articles

  • Design Controls

    2 articles

  • Aviation Compliance

    2 articles

  • NCR Report

    2 articles

  • Regulatory Submission

    2 articles

  • Complaint Management Systems

    2 articles

  • ISO 9001 Standard

    ISO 9001 Standard: Complete Guide to Quality Management

    eLeaP Editorial Team

    July 9, 2025

    9 min read

    ISO 9001 Standard: Complete Guide to Quality Management

    The ISO 9001 Standard serves as the global benchmark for Quality Management Systems (QMS), helping organizations streamline processes, boost efficiency, and consistently deliver quality. Published by the International Organization for Standardization (ISO), the ISO 9001 Standard is part of the larger ISO 9000 family and applies to any organization, regardless of size or industry. Organizations […]

    Continue reading

  • Medical Device Audits

    Medical Device Audits: Complete Compliance Guide 2025

    eLeaP Editorial Team

    July 4, 2025

    17 min read

    Medical Device Audits: Complete Compliance Guide 2025

    Medical device audits represent systematic evaluations that verify manufacturer compliance with regulatory standards, quality management systems, and safety requirements throughout the product lifecycle. These audits have evolved from reactive compliance checks into proactive strategic assessments that demonstrate continuous quality improvement and regulatory alignment. A medical device audit is a formal, structured assessment of a company’s […]

    Continue reading

  • cGMP Guidelines

    What Is Good Automated Manufacturing Practice (GAMP)? A Complete Guide to GAMP 5 and Modern Compliance

    eLeaP Editorial Team

    July 4, 2025

    11 min read

    What Is Good Automated Manufacturing Practice (GAMP)? A Complete Guide to GAMP 5 and Modern Compliance

    Good Automated Manufacturing Practice (GAMP) serves as the cornerstone framework for validating computerized systems in regulated manufacturing environments. Developed by the International Society for Pharmaceutical Engineering (ISPE) in 1991, GAMP has evolved into the globally recognized standard that ensures automated systems consistently operate within predefined limits while maintaining product quality, patient safety, and regulatory compliance. […]

    Continue reading

  • GDP Compliance

    GDP Compliance: Key Requirements for Pharma Supply Chain Management

    eLeaP Editorial Team

    July 3, 2025

    10 min read

    GDP Compliance: Key Requirements for Pharma Supply Chain Management

    Good Distribution Practice (GDP) compliance governs the maintenance of quality, safety, and efficacy of pharmaceutical products throughout the distribution process. GDP compliance differs from Good Manufacturing Practice (GMP) in that it focuses exclusively on the handling, storage, and transport phases, rather than production. The framework ensures medicines reach patients without compromising therapeutic effectiveness or introducing […]

    Continue reading

  • 21 CFR Part 11

    21 CFR Part 211: Ultimate CGMP Compliance Guide

    eLeaP Editorial Team

    June 29, 2025

    11 min read

    21 CFR Part 211: Ultimate CGMP Compliance Guide

    21 CFR Part 211 represents the core FDA regulation establishing Current Good Manufacturing Practice (CGMP) requirements for finished pharmaceuticals in the United States. This legally binding regulation ensures all drugs are manufactured consistently with high quality, free from contamination, and adequately documented throughout the production process. Issued by the U.S. Food and Drug Administration under […]

    Continue reading

  • Complaint Management Systems

    Complaint Management Systems: Complete Implementation Guide

    eLeaP Editorial Team

    June 28, 2025

    8 min read

    Complaint Management Systems: Complete Implementation Guide

    A complaint management systems serves as a centralized platform for receiving, processing, and resolving customer complaints across multiple channels. Modern complaint management systems have evolved far beyond traditional manual logbooks and spreadsheets, leveraging advanced technology to automate complaint capture, streamline resolution workflows, and provide actionable business insights. The core functionality of a complaint management system […]

    Continue reading

  • Continuous Improvement Cycle

    Complete Guide to the Continuous Improvement Cycle

    eLeaP Editorial Team

    June 21, 2025

    20 min read

    Complete Guide to the Continuous Improvement Cycle

    The continuous improvement cycle represents a fundamental shift from reactive problem-solving to proactive process optimization. This structured, iterative methodology enables organizations to achieve operational excellence by systematically enhancing processes, systems, and outcomes. Unlike traditional quality assurance approaches that focus on detecting and correcting problems after they occur, the continuous improvement cycle creates a culture where […]

    Continue reading

  • Compliance Culture

    GxP Compliance: Everything You Need to Know to Stay Audit-Ready

    eLeaP Editorial Team

    June 20, 2025

    11 min read

    GxP Compliance: Everything You Need to Know to Stay Audit-Ready

    Regulatory inspections can arrive unannounced, demanding immediate access to documentation, training records, and evidence of systematic compliance. For pharmaceutical manufacturers, clinical research organizations, and medical device companies, maintaining audit-ready GxP compliance isn’t just about meeting regulatory requirements—it’s about protecting product integrity, patient safety, and business continuity. This comprehensive guide reveals the essential elements of GxP […]

    Continue reading

  • Life Science

    Life Science Domain: Key Industries and Career Paths

    eLeaP Editorial Team

    June 18, 2025

    8 min read

    Life Science Domain: Key Industries and Career Paths

    The life science domain represents a $1.74 trillion global ecosystem where biology meets technology to solve humanity’s most pressing challenges. This expansive field encompasses biotechnology, pharmaceuticals, medical devices, and emerging sectors like synthetic biology, creating unprecedented career opportunities for professionals across multiple disciplines. The life science domain integrates biology, chemistry, physics, and advanced technologies to […]

    Continue reading

  • Audit Management

    Medical Device Audits: Complete Compliance Guide

    eLeaP Editorial Team

    June 13, 2025

    10 min read

    Medical Device Audits: Complete Compliance Guide

    Medical device audits serve as critical gatekeepers for product safety and regulatory compliance in healthcare. These structured assessments evaluate whether manufacturers meet established quality and regulatory requirements across the entire product lifecycle—from initial design through post-market surveillance. Unlike routine quality checks, medical device audits are comprehensive evaluations that examine design controls, manufacturing processes, distribution systems, […]

    Continue reading

  • Previous
  • 1
  • 2
  • 3
  • 4
  • …
  • 19
  • Next

About eLeaP

  • About eLeaP®
  • Excellence
  • Learning Management
  • Performance Management
  • Quality Management

Capabilities

  • Quality Management System
  • Learning Management System
  • Performance Management System
  • 21 CFR Part 11 LMS
  • 14 CFR Parts 145, 135, 43, 91, 121 LMS
  • Free Downloadable SOPS
  • Brochures

Articles

  • Quality Management
  • Quality Management Software
  • QMS

Support

  • Resources
  • Glossary
  • Sitemap

Get in Touch

(877) 624-7226

support@eleapsoftware.com

  • Contact eLeaP
  • LinkedIn
  • YouTube
  • X
  • Facebook

© 2002 - 2025 Telania, LLC.

  • QMS Privacy Policy