News
What is a Quality System, and Why Have One?
This is a common question... and a valid one! It’s easy to make things complicated, but below, we break down this question in easy-to-understand terms. What is a quality system? A quality system is a structured and formalised approach that enables an organisation to manage and maintain [...]
Why the Best Quality Systems Are Not the Most Complex
The Quality System Paradox Somewhere along the way, complexity became confused with quality. In regulated environments, additional procedures, approval steps, and documentation are often seen as evidence of stronger control. The assumption is understandable. However, complexity alone does not guarantee better quality outcomes. Too often, the result is [...]
Tower Mains Monthly Newsletter – August 2026
Regulatory Updates EMA Launches Initiatives to Strengthen Medicines Development for Women’s Health On 2nd July, the EMA announced new initiatives to address gaps and challenges in women’s health and support the development of medicines that better reflect women’s needs. The activities will focus on improving evidence generation, representation [...]
Edinburgh Fringe 2026 Recommendations
Edinburgh Fringe 2026 Recommendations It’s that time again! Despite some challenging traffic issues in the city centre (if you were planning to get the tram past town, please keep an eye on the updates) and some potential changes in road closures and venues for Assembly George Street, here’s [...]
25 Sponsor Oversight Findings from Clinical Trials
25 Sponsor Oversight Findings from Clinical Trials That Commonly Lead to Issues During Regulatory Inspection Effective sponsor oversight is essential for safeguarding participant safety, ensuring data integrity, and maintaining regulatory compliance throughout the clinical trial lifecycle. Although sponsors may delegate trial-related activities to CROs and other service providers, they retain ultimate responsibility for the overall conduct, [...]
Tower Mains Monthly Newsletter – July 2026
Company News We’re delighted to be exhibiting at the Bionow Neuroscience Conference in Sheffield next week! If you’re attending, come and say hello. Stacey will be on hand to discuss how Tower Mains can support you. Regulatory Updates EMA and African Regulatory Authorities Strengthen Collaboration on Ebola Response [...]
25 Lessons Learned When Conducting CAPA
25 Lessons Learned When Conducting CAPA In Pharmaceutical Environments (GxP) Corrective and Preventive Action (CAPA) is a cornerstone of pharmaceutical quality systems, providing a structured framework to investigate deviations, identify root causes, implement corrective actions, and prevent recurrence. Drawing on experience across GxP (GMP, GCP, GVP, and GLP) [...]
Tower Mains Monthly Newsletter – June 2026
Company News We were delighted to be well represented at the Research Quality Association (RQA) 2026 International QA Virtual Conference last month. Nicole Ainsworth, Stacey Harding, Rosemary Ichaba, and Anna Lothian all contributed to the programme, covering topics including veterinary GCP, audit challenges in GxP environments, and environmental [...]
25 Lessons Learned from Conducting Robust Risk Assessments
25 Lessons Learned from Conducting Robust Risk Assessments in Pharmaceutical Environments (GMP, GCP, GVP, GLP) Risk assessments play a critical role across pharmaceutical environments, influencing how organisations identify vulnerabilities, implement appropriate controls and maintain inspection readiness. Whether assessing manufacturing processes, clinical activities, pharmacovigilance systems or computerised systems, the quality of [...]
Tower Mains Monthly Newsletter – May 2026
Company News ICH GCP E6 (R3) has officially come into effect in the UK, bringing a stronger focus on risk-based approaches, data integrity, and modern trial delivery. These changes will shape how clinical trials are designed, managed, and inspected. To help organisations understand the practical impact, we’ve launched [...]
