In October 2001, Dr Andrew and Fiona Waddell took a leap into the unknown. Armed with funding, ambition, and a clear vision, they set out to build a consultancy of their own, not knowing quite where the journey would lead. Twenty-five years on, Tower Mains is an established consultancy providing [...]
The Trial Master File (TMF) plays a critical role in demonstrating that clinical trials are conducted appropriately, with a focus on participant safety, data integrity and regulatory compliance. The following 25 TMF issues highlight common deficiencies that can lead to adverse findings during regulatory inspections. Recurring or systemic [...]
Root cause analysis (RCA) is a key part of managing deviations, incidents and quality issues within GxP environments. But conducting a robust RCA is not always straightforward. Drawing on our experience across GCP, GMP, GLP and GVP, here are 25 lessons learned that can help organisations strengthen their [...]
Investigator sites play a critical role in ensuring clinical trials are conducted appropriately, with a focus on participant safety, data quality and regulatory compliance. The following 25 red flags highlight common areas that can lead to regulatory inspection issues. While individual issues may appear minor, recurring or systemic [...]
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 the [...]
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 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, [...]
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) [...]
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 [...]
25 Key Learnings from Exhibiting at GxP Conferences As our conference season kicks off, we’re looking forward to connecting with quality professionals across the industry and hearing first-hand about the challenges, priorities, and opportunities shaping the GxP landscape. Whether through discussions at our exhibition stand or topics raised during workshops, presentations, and panel sessions, many of the [...]
Data integrity is often talked about in terms of systems, controls, and regulations. In reality, it’s about people, culture, and how day-to-day processes are carried out. Across GLP, GCP, GMP, and PV in clinical trials, the same patterns keep showing up – different domains, same underlying issues. Below [...]
25 Things Learned from 25 Years of GxP Audits Auditing is often perceived as a technical exercise built around checklists and findings. In reality, it is far more nuanced and human, shaped by preparation, communication, judgment, and an ability to understand how systems operate in practice, not just [...]
This year, we celebrate 25 remarkable years! To kick off our 25 Years of Tower Mains series, we’re taking a nostalgic look back at 2001 – the year it all began – when flip phones were everywhere, internet connections tested our patience, and the technology we now rely [...]
There’s something unmistakably magical about Edinburgh in December. From dazzling light displays and bustling markets to colourful outdoor trails and cosy winter refuges, it’s a place that feels lifted straight from the pages of a storybook. Here’s our guide to experiencing the very best of Tower Mains’ home [...]
In this article, written for the Research Quality Association (RQA)’s QUASAR November 2025 issue, Victoria Macleod presents a pragmatic approach to quality systems that are Agile, Simple, Accurate, and Pragmatic. By focusing on fit-for-purpose, scalable, and people-focused solutions, teams can stay compliant, functional, and empowered, avoiding over-engineering while ensuring quality [...]
Pictured: Andrew Waddell with Scottish FA President, Mike Mulraney We’re thrilled to share more exciting news as we celebrate one of our Founder Directors, Dr Andrew Waddell, who was the Scottish Football Association’s Guest of Honour at the World Cup Qualifying match between Scotland and Belarus. Andrew [...]
We have exciting news to share! The Board at Tower Mains is delighted to announce the appointment of Lianne Roeling as Company Secretary! Lianne currently serves as Head of Operations, and her promotion marks an important milestone in the continued growth and development of the Company. Well done, [...]
In today’s rapidly evolving world, continuous learning is more crucial than ever, particularly for Quality Assurance (QA) professionals. Regulations, technologies, and methodologies constantly change, making it imperative for QA teams to stay up to date with best practices, compliance standards, and regulatory frameworks. In sectors such as pharmaceuticals, [...]
Top Things to Do and See in Edinburgh Summer in Edinburgh is nothing short of magical - even when it rains! With its dramatic skyline, seamless blend of old and new, and craggy natural surroundings, it’s easy to see why this is considered one of the most beautiful cities in [...]
Inspections by regulatory authorities can have significant implications – failing one can lead to penalties, reputational damage, and the potential suspension of operations, whilst a successful inspection can bolster confidence and assure the quality and safety of your products or services. Whether your inspection is looming or [...]
A QA Perspective on the Annual Tower Mains Get-Together At the end of last year, the Tower Mains team got together in Edinburgh for a festive evening of food, drinks, entertainment, and activities. However, as Quality Assurance professionals, we couldn’t help but evaluate the event through the lens of continuous [...]
Today, continuous learning is more crucial than ever, particularly for Quality Assurance (QA) professionals. As industries advance and regulations evolve, staying up to date with the latest practices, technologies, and compliance standards is imperative. In this article, written for the Research Quality Association (RQA)’s QUASAR February issue, Victoria Macleod highlights [...]
Meet the Team – Q&A with Associate Stacey Harding After earning a first-class honours degree in Neuroscience from the University of Nottingham, Stacey began her research career as a Clinical Trial Assistant in a Phase 1 Unit. She later transitioned into quality assurance, gaining experience auditing for a global CRO [...]
Top tips for choosing the right QA consultancy There are many reasons why your organisation may be in the market for a QA consultancy – including growing your company or services, staffing challenges or backlogs – and while there is no shortage of consultancies available, it’s essential to find the [...]
If you’re looking for flexible, pragmatic, and cost-effective Quality Assurance services... look no further! With over 200 years of combined experience, the Tower Mains team is on hand to provide you with Quality Assurance services when and where you need them – from short ad hoc projects to long-term QA [...]
Key Considerations for a Good Lab Investigation When things don’t go to plan in a laboratory, a good investigation is pivotal to understanding what went wrong and ensuring all necessary steps have been taken to identify the error, understand the root cause and prevent recurrence. Before embarking on a career [...]
Katarina: Celebrating 10 years at Tower Mains Join us in celebrating a milestone as we honour Katarina Eghan, who is marking an incredible ten years with Tower Mains! Since joining our team in 2013, Katarina has made a huge impact on the company, bringing her expertise and dedication [...]
Happy World Book Day! Finding moments of tranquillity and self-care can sometimes feel like a luxury in a world filled with constant distractions and busy schedules. However, amidst the chaos of daily life, one timeless activity stands out: reading. Beyond its role as a source of entertainment or education, reading [...]
In this article, written for the Research Quality Association (RQA)’s QUASAR November 2023 issue, Anna Lothian highlights the importance of introducing Quality Assurance (QA) and GxP principles, such as GMP, GLP, and GCP, into life sciences degree programmes. Drawing from her own industrial placement experience, she explains how early exposure [...]
Travel tips for auditors Travel is often a necessity rather than a luxury, and whilst it can be exciting, venturing into unfamiliar territories can also pose a challenge. To enhance your travel experience, below are a few travel tips to make your trips more productive and a little less stressful. [...]
Our Top Places to Visit in Scotland It’s summer and there’s no better time to explore Scotland! Summer is a time when the country comes to life, allowing visitors and locals to immerse themselves in its breathtaking scenery, festivals, heritage and, of course, its ‘liquid gold.’ From unravelling the rich [...]
Meet the Team - Q&A with Senior Associate Anna Lothian After graduating with a first-class honours degree in Biomedical Sciences from the University of Dundee, Anna began her career in the medical device field, starting as a lab technician and working towards a technical manager role in Research & Development [...]
Without a doubt, performing services on-site has its advantages, for example, on-site audits allow the auditor to examine processes in real-time, complete in-person facility tours and interviews, and observe non-verbal communication, and training courses held in person tend to be more interactive. However, with technological advances, training, audit, and consultancy [...]
How to Create a Comfortable Working Environment as an Auditor Almost everyone within the working environment experiences the sudden audit notification and is automatically thrown into a mental frenzy of questions... Why are they coming? What will they be observing? And why now? These may be among a few questions [...]
? Attention clinical researchers and trial sponsors! ? With the increased use of computerised systems in clinical trials, it is crucial that data integrity and patient safety are a top priority, and that the requirements for compliant data management are understood. In March 2023, the EMA published guidance to address [...]
Meet the Team - Q&A with Training Associate Erin Bell After graduating with an honour’s degree in Microbiology, Erin began her scientific career as a lab technician in a veterinary serology laboratory before transitioning to a global CRO to work in human clinical trials. From here, she progressed her way [...]
Meet the Team – Q&A with Senior Associate Rosemary Ichaba Rosemary was introduced to QA after completing a Masters in Drug Discovery and Pharma Management and from here she branched out into Project Management, working within a Global CRO for two and a half years. Following this, she became QA [...]
Happy World Book Day! Did you know that reading for as little as six minutes per day can reduce stress by as much as 68%? Reading has some amazing health benefits, including improving your mental acuity, helping with anxiety, relieving stress, and lowering the chances of developing Alzheimer’s later in [...]
Tower Mains welcomes Anna to the team We are delighted to welcome Anna Lothian to the Tower Mains team! With a first-class honours degree in Biomedical science from the University of Dundee and an industrial placement year at a medical devices company under her belt, Anna began her career in [...]
Tower Mains welcomes Erin to the team We are delighted to welcome Erin Bell to the Tower Mains team! Erin graduated from the University of Glasgow with an honour’s degree in Microbiology, making trips to Africa throughout her studies to work with hospitals and small charities to train and help [...]
Looking forward to 2023 and beyond After a successful 2022, we are looking forward to further expanding our expert team, building on our range of services, and increasing our footprint in 2023 and beyond. With this in mind, we are delighted to announce the following changes to our Executive team: [...]
Happy Burns Day! It’s the 25th of January, the day we pay tribute to the life and work of Scotland’s ‘national bard’, Robert Burns. The first Burns supper is thought to have taken place over 200 years ago in 1801, where nine acquaintances of the late poet came together to [...]
Have you identified your QA support needs for 2023? Are you thinking about your upcoming audit schedule for 2023? Are you yet to identify your QA support needs? Ask yourself the following questions... ✅ Are you using your risk assessment? ✅ Do you have your audit plan in place? ✅ [...]
Happy St Andrew's Day For Scottish people all over the world, St Andrew’s Day – also known as ‘Andermas’ or ‘the Feast of Saint Andrew’ – is a time to think of home, celebrate and feast with friends old and new, across the world. But who is Scotland’s patron saint, [...]
Tower Mains is delighted to be attending the Research Quality Association (RQA) RE:UNITED International Conference! Don’t miss our Head of Quality Assurance Shona Ross who will be taking part in the below sessions: ✅ GLP – Audit Findings and Responses at 2pm, Wednesday ✅ GLP/GCLP Question Time at 2pm, Thursday [...]
Meet the Team – Q&A Rhona McAteer, Senior Associate Director Tower Mains’ longest-serving team member, Rhona has been working in the pharmaceutical industry for over 25 years, initially in steriles QC microbiology before moving into pharmaceutical and medical device QA where she was promoted to Manager, Quality Assurance and Regulatory [...]
Tower Mains welcomes Rosemary to the team Tower Mains is delighted to welcome Rosemary Ichaba to the team. Rosemary was introduced to QA after completing a Masters in Drug Discovery and Pharma management and from here she branched out into Project Management, working within a Global CRO for two and [...]
Tower Mains is pleased to announce the following promotions Our Associate Director and Head of Operations Lianne Roeling, will be expanding her Business Development role, specifically to support the growth of our training services. These will be co-ordinated by Naomi Ervine who has been promoted to Principal Associate. Naomi will [...]
Meet the Team - Q&A with Nicole LeBlanc QA Associate Hailing from Canada, Nicole moved to Scotland in 2016 after graduating from the University of Alberta with a BSc in Agriculture and a Major in Animal Science. She began her career as an animal technician in 2017 before moving to [...]
Meet the Team – Q&A with Senior Associate Judith O’Hagan With over 20 years of experience within clinical research – initially as a research and development scientist before moving her way up to Senior Laboratory Manager – Judith joined Tower Mains in 2021 as a Senior Associate. Here, she tells [...]
MHRA Compliance Monitoring Scheme: Step in the right direction or first on a slippery slope? From April 2022, the MHRA will begin a pilot programme for GMP and GDP remediation supervision by eligible consultants acting as Compliance Monitors (CM) to reduce the significant burden on the agency resources by the [...]
Happy World Book Day! Did you know that reading for just six minutes a day reduces stress by a huge 68%? Reading not only expands our general knowledge, but it’s also a great memory exercise, can increase our emotional intelligence, and can help people lead more peaceful lives. Plus, reading [...]
Tower Mains is pleased to announce senior appointments Tower Mains Ltd, a leading international provider of Quality Assurance and Consultancy services, is pleased to announce the following senior appointments. Rhona McAteer has been promoted to Senior Associate Director; Shona Ross and Lianne Roeling have been promoted to Associate Directors as Head of QA and [...]
Written by Victoria Macleod for the the Research Quality Association (RQA)’s January 2022 QUASAR issue, this article celebrates the 20-year success of Tower Mains and highlights the careers of co-founders Dr Andrew and Fiona Waddell. It explores their pioneering contributions to Quality Assurance, clinical research, and Good Laboratory Practice (GLP), [...]
Meet the Team – Q&A with our Head of QA, Shona Ross After working in various roles in pre-clinical and clinical research – including Study Director and Responsible Scientist for bioanalytical studies – Shona joined us in 2015 as an Associate. Since then, she has taken on several senior roles, [...]
Tower Mains welcomes Nicole LeBlanc as QA Associate We are excited to welcome Nicole LeBlanc to the team as QA Associate Hailing from Canada, Nicole moved to Scotland in 2016 after graduating with Distinction from the University of Alberta in Canada with a BSc in Agriculture and a Major in Animal [...]
Words from the Directors In celebration of Tower Mains’ birthday month, our directors Andrew and Fiona Waddell recap on the last twenty years… In October 2001 - exactly twenty years ago - we took a deep breath and posted the Notice of Incorporation for Tower Mains Limited to Companies House. [...]
Tower Mains welcomes Judith O'Hagan as Senior Associate We are delighted to welcome Judith O'Hagan to the team as Senior Associate. Judith joins us with over 20 years of experience in clinical research. After graduating with a degree in Biomedical Sciences, she began her career as a research and development [...]
Meet the Team - Q&A with our Director, Andrew Waddell With over forty years in the industry, including almost twenty as Director at Tower Mains, Andrew Waddell talks us through his career highlights and lowlights, tips on how to succeed in QA, and what makes him tick outside of Tower [...]
Q&A with Rhona McAteer, our GMP Expert Looking for expert advice on Good Manufacturing Practice (GMP)? Look no further! With over 25 years in the pharmaceutical industry – initially in steriles QC microbiology before moving into pharmaceutical and medical device QA – Rhona McAteer, our Associate Director and GMP expert, [...]
For almost twenty years, Tower Mains has been proud to offer and provide international audit, consultancy, and training services. With over 200 years of global regulatory experience, our diverse team is on hand to offer flexible, credible, and cost-effective quality assurance support services – from short ad hoc projects to [...]
Our objective is to bring you first-class training that meets your needs and allows you to understand the complexities of regulations, guidance and inspector expectations. Each course is led by an expert in the field, and they use their experience and expertise to bring their topic alive with information, and [...]
The '5C' approach to QMS The QMS is more than just a list of documented procedures and processes. It links to every facet of your organisation’s performance no matter how big or small you are, therefore driving a quality culture throughout and ensuring everyone is responsible for quality. It’s organic, [...]
Implementation of ISO9001:2015 QMS can be daunting and confusing. Here at Tower Mains, we have put together a simple yet effective infographic that explains; the 7 Quality Management principles, the 9001 approach, the PDCA Cycle, and how the clauses of the standard align to the PDCA cycle and, of course, links [...]
Many challenges face the multicultural auditor today… Which is why our Director Andrew Waddell chose to shed some light on the topic at the #RQA2020 International QA Conference on Tuesday. It certainly was a difficult topic to summarise in 25-minutes but, never one to shy away from a challenge, Andrew [...]
Tower Mains is pleased to announce training courses to help you, your employees and colleagues stay up to date with the latest practices, standards and guidelines are now on our new website. We’ve been running training courses for many years. However, times change, expectations and requirements change, and we decided [...]
Who are we? Tower Mains Ltd was first established in 2001 as an independent Research Quality Assurance consultancy that became widely known as TMQA. Our core business was conducting audits for clinical trials, regulatory laboratories, pharmaceutical manufacturing, and other biotech industries. Our Tower Mains’ team has acquired a diverse set [...]
Tower Mains staff have experience of providing remote training to people and groups around the world. The benefits of groups working with experts “face to face” are well understood, especially the personal interactions such courses provide. This is not always possible or desirable when considering cost and environmental impact of [...]
