Expert Insights and Resources for Life Sciences Quality and Compliance
Enhance your expertise with our insightful articles, crafted by seasoned professionals to bolster your learning journey. The Knowlogy stands committed to delivering top-tier Quality Assurance support within the Life Sciences industry. Our ‘Articles for Download’ section serves as an extensive repository, providing authoritative insights on GLP, GCP, GCLP, CSV, Training, Consultancy, and ISO standards including 9001, 17025, and 15189. Each piece offers actionable advice and forward-thinking approaches designed to propel your organization to the forefront of this dynamic and stringently regulated domain.
We cover a range of topics from quality assurance auditing to computer system validation. We also cover the softer skills too to encapsulate best practice and the pressures of the modern life science industry.
We are always keen to hear your feedback and suggestions for new topics. Please you the Contact Us page, we look forward to hearing from you.
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Implementing ISO 17025 to Avoid Common Challenges & Pitfalls
ISO/IEC 17025 is an international standard that applies to any organisation that performs testing, sampling, or calibration. The globally recognised standard aims to ensure the reliability and validity of results, build confidence in laboratory outputs, and demonstrate a laboratory has achieved a level of competence, impartiality, and operational consistency. The Benefits of ISO/IEC 17025 accreditation…
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What’s the Difference Between QMS, eQMS & eDMS?
Selecting an effective system to manage quality and compliance is essential for organisations operating across life sciences, pharmaceuticals and healthcare. With stringent regulatory requirements and significant risks linked to non-compliance, adopting a modern, streamlined quality system can boost efficiency, minimise errors, and play a vital role in safeguarding patient safety. In this article, we’ll explain…
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Navigating the Storm: Strategies for Stress Management in Healthcare
Navigating the Storm: Strategies for Stress Management in Healthcare Working in the medical field can be incredibly rewarding, yet it’s often accompanied by significant stress and burnout. This article from The Knowlogy delves into several vital strategies aimed at assisting healthcare professionals in effectively managing stress and maintaining their well-being. These approaches are crucial for…
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QMS: An Investment Not a Cost – How Quality Management Systems Drive Success in Life Sciences
QMS: An Investment Not a Cost – How Quality Management Systems Drive Success in Life Sciences. A Quality Management System (QMS) is a structured framework of processes, procedures, and responsibilities for achieving quality policies and objectives. It helps organisations coordinate and
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Transforming Laboratory Practices: How GCP Compliance Drives Success
Introduction to GCP Good Clinical Practice (GCP) is a set of internationally recognised ethical and scientific quality requirements that must be observed when designing, conducting, recording, and reporting clinical trials that involve human participants. These guidelines ensure the integrity of clinical trials and protect the rights, safety, and well-being of trial subjects. GCP compliance is…
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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 ISO standard it wishes to comply with….
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ISO: An Essential Step-by-Step Guide to Certification
Whether improving internal ISO 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…
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Value of an ISO Audit to the Auditee
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, as well as assessing…
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Elaine McLachlan’s joins The Knowlogy to Expand ISO Standard Support Services
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,…
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The Quality Manual in ISO 15189:2022:An Essential Artifact or a Relic of the Past?
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 15189:2022 ushers in a wave of change, casting a spotlight on the Quality Manual’s evolving role. Is it time to reconsider its value? A Historical Cornerstone For years, the…
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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…
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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…
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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…
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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…
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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,…
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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…
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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.
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The GxP Vendor Selection Guide: Avoiding the Top 5 Mistakes
1. Evaluating GxP Expertise: Does Your Vendor Make the Grade? In the age of cyber threats and data breaches, ensuring data integrity has never been more crucial. Mistake 2: Not giving due attention to a vendor’s data practices. A lapse in data integrity can jeopardise your entire GxP compliance. The Fix: Scrutinize the vendor’s data…
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Computerised System Validation: Top 5 Common Pitfalls
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…
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The Virus Afflicting Our Audits!
The Virus Afflicting Our Audits! Most companies in the pharma/biotech world have been impacted by the COVID-19 pandemic in more ways than one. An area that has been hit is the audit schedule. You may have already planned out the full year with delayed audits from 2020 rescheduled to 2021. Although we are recovering there…
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16 Tips for an Effective Meeting
16 Tips for an Effective Meeting. Learn how to make meetings more effective and engaging. Use the tips and share them with your colleagues. A free download. The Knowlogy, sharing knowledge in the Life Science sector. Download your free copy now. Download here
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9 Essential Elements for Effective Audit Plans
Having a comprehensive audit plan is key for conducting a successful audit. To make it simple, The Knowlogy has put together our 9 essential elements for effective audit plans. 1. Audit Rationale The audit rationale is why the audit is required. For most audits, the why is usually answered by the design of the audit…
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Who Audits the QA Programme?
Who Audits the QA Programme Or who audits the Auditors? The UK GLP monitoring authority in 2015 issued guidance on their expectations that the quality assurance programme is included in GLP facilities audit schedule. A few organisations outside of the UK have applied this guidance but not many. But why should you include the QA…
