Articles
Document requirements – ISO 15189:2022, ISO 17025:2017
“What documents do we need to prepare?” this is often the first question you would ask yourself. Identifying the required documentation is one of the first steps, and one of the most important, in building a Quality Management System. This should be assessed after the organisation identifies the standards it wishes to comply with. Good…
ISO: An Essential Step-by-Step Guide to Certification
Whether improving internal processes or meeting the demands of customers and regulatory bodies, ISO standards are a beacon of excellence and reliability in the global marketplace. This comprehensive guide is designed to clearly explain achieving ISO certification, outlining a straightforward, step-by-step process tailored to prepare your organisation for success. Let’s start with clarifying the…
Value of an ISO Audit to the Auditee
General article – notes: ISO (internal audits) Article “The laboratory shall conduct internal audits at planned intervals” is a statement written in many ISO standards, meaning internal audits must be performed. Internal audits are required to provide information on how the organisations’ management system complies with the ISO standards and compliance with their documented procedures,…
Elaine McLachlan’s joins The Knowlogy to Expand ISO Standard Support Services
We are excited to announce a significant addition to our team at The Knowlogy. Elaine McLachlan has joined us as a Quality Consultant, specializing in ISO Standards ISO9001, ISO17025, and ISO15189 as well as supporting clients with GCLP and HTA. In her new role, Elaine brings a wealth of experience and a commitment to excellence…
The Quality Manual in ISO 15189:2022:An Essential Artifact or a Relic of the Past?
In the realm of medical laboratory quality management, the introduction of ISO 15189:2022ushers in a wave of change, casting a spotlight on the Quality Manual’s evolving role. Is ittime to reconsider its value? A Historical Cornerstone For years, the Quality Manual stood as the linchpin of the Quality Management System(QMS), a comprehensive document that encapsulated…
GLP Laboratory Case Study: Overcoming Documentation Control Challenges
Problem Overview A Good Laboratory Practice (GLP) Laboratory faced significant challenges that were highlighted during a major finding by the Medicines and Healthcare products Regulatory Agency (MHRA). The finding revealed a crucial issue within the laboratory’s Standard Operating Procedure (SOP) system, indicating that it was not under the appropriate control. This was evidenced by a…
In-House versus CSV Consultancy – Performing Computer System Validation (CSV)?
Why Validated Computerised Systems? GLP and GCP regulations require that if a computerised system is involved in the process of generation, measurement, storage or assessment of data, then it must be validated to ensure the accuracy and integrity of the data generated by the system. What is Computerised System Validation Validation of computerised systems is…
3-minute interview with Joe Turton CSV specialist
Let us introduce you to Joe Turton, our esteemed consultant and CSV specialist at The Knowlogy. In this 3-minute interview, find out about Joe’s professional background, top tips and industry trends. Also, we explore how Joe’s unique combination of skills has greatly assisted organisations, particularly small and medium-sized enterprises, in establishing robust and compliant CSV…
Maximising Efficiency and Compliance: The Power of Risk-Based CSV
In an era where technological advancements and regulatory demands are ever-evolving, organisations face significant challenges in maintaining efficient and compliant Computerised System Validation (CSV). A Risk-Based CSV approach emerges as a solution, tackling key pain points that plague traditional methods. Let’s delve into how this approach revolutionises CSV. Efficient Resource Allocation Traditional Challenge: Traditional CSV…
Harmonising GLP, GCLP, and ISO 17025 with The Knowlogy Group’s training courses
Introduction For organisations operating in highly regulated industries like pharmaceuticals and biotechnology research, managing change effectively is not just a matter of success but a compliance necessity. However, many companies still grapple with siloed processes when it comes to Good Laboratory Practice (GLP), Good Clinical Practice for laboratories (GCLP), and ISO 17025. To integrate processes,…
Unveiling the Heart of GxP: The Power and Precision of Root Cause Analysis
In the intricate world of GxP, ensuring quality, safety, and efficacy is paramount. A pivotal technique that stands as a beacon in this quest for excellence is the Root Cause Analysis (RCA). But what exactly is RCA, and why is it so fundamental? Root Cause Analysis: Digging Deeper At its core, RCA is dedicated to…
Demystifying CAPA: Ensuring Quality in the GxP Realm
(CAPA) system is a vital pillar. CAPA is not just a protocol; it’s a holistic approach ensuring the highest quality and safety standards. This article explains the CAPA system’s significance and best practices in GxP-regulated industries.
The GxP Vendor Selection Guide: Avoiding the Top 5 Mistakes
In the GxP world – spanning from Good Laboratory Practice (GLP) to Good Manufacturing Practice (GMP) and beyond – choosing the right vendor can make the difference between success and a costly oversight. Whether you’re a seasoned professional or new to the realm of GxP, the following guide will help you navigate the tricky waters…
Navigating the World of Electronic Signatures in GxP Environments
Demystifying Electronic Signatures in GxP Environments Today’s business world revolves around digital transformation, and regulated industries are not an exception to this trend. A key aspect of this digital revolution is using electronic signatures in Good Practice (GxP) environments. Electronic signatures – digital counterparts of traditional handwritten signatures – hold legal validity and provide a…
Computerised System Validation: Top 5 Common Pitfalls
Welcome to our comprehensive series on the pivotal area of regulatory compliance, specifically Computerised System Validation (CSV). The stakes in this complex terrain are high, with intricate regulations, expensive mistakes, and compliance requirements all posing business challenges. Over the course of this blog, we’ll dissect the “Top 5 Common Pitfalls” that organisations commonly stumble upon…