Quality System Support
An organisation’s quality system should be simple, meaningful and consistent with the relevant standards. It must be flexible enough to grow and adapt as your organisation grows.
Tower Mains designs bespoke quality systems and development plans for pharmaceutical, biotechnology, healthcare, medical device, research and non-commercial organisations. Our approach can be aligned with regulatory requirements and quality frameworks including GCP, GLP, GMP and ISO 9001, helping organisations establish practical and effective systems that support compliance, operational effectiveness and continuous improvement throughout their lifecycle.
Why effective quality systems matter
A robust quality system helps organisations maintain control of regulated activities, support consistent decision-making and demonstrate effective oversight to regulators, partners and stakeholders.
Without effective quality system oversight, organisations may experience:
Inconsistent processes and unclear responsibilities.
Gaps in quality governance and compliance oversight.
Challenges maintaining effective documentation and procedures.
Increased risk during audits, inspections, or regulatory assessments.
Quality systems that do not evolve with organisational needs.
Tower Mains helps organisations strengthen their quality systems through practical, risk-based support that improves compliance, enhances operational effectiveness and supports inspection readiness.
Our quality system experience
The Tower Mains team has extensive experience developing and managing fit-for-purpose quality systems across both regulated and non-regulated environments.
Our experience includes:
Building regulatory quality systems for a new facility
Extending a GLP laboratory quality system to comply with EMA GCP laboratory requirements
Adjusting a non-regulatory quality system to meet regulatory requirements
Independent review of an existing quality system against a standard and providing an action plan for regulatory compliance
Our approach
Our approach provides a structured pathway to evaluate, strengthen and maintain your quality system.
1. Evaluate
Assess your current system and processes to identify gaps and opportunities for improvement.
2. Action Plan
Develop a prioritised action plan outlining what is required to achieve compliance and strengthen your quality system.
3. Implement
Tower Mains will support you in implementing the action plan across your organisation.
4. Assess
Verify quality system compliance with an independent audit.
Quality system evaluation
Tower Mains can evaluate your current quality system to identify regulatory compliance deficiencies and areas for improvement against applicable regulatory and internal quality standards. We provide practical recommendations to address identified gaps and can support ongoing performance review to help ensure your quality system remains effective and aligned with evolving requirements.
Documented procedure development
Complementing our quality system consultancy, Tower Mains can support you with creating or maintaining clear, practical and fit-for-purpose documentation. Whether you need support with a Site Master File, Quality Manual, SOPs, work instructions, forms or templates, our team can help develop documentation that is effective and easy to use.
Our approach is flexible and tailored to your specific needs:
Mapping processes using custom, organisation-specific diagrams
Revising existing documents to simplify content
Developing fit-for-purpose SOPs and controlled documents
Using other technologies for documenting instructions such as video-based guidance
Why choose Tower Mains?
Global GxP Expertise
Access experienced auditors, quality professionals and subject matter experts across the GxP landscape, from clinical and laboratory environments to manufacturing, devices and research. We bring industry experience and specialist insight to help you address quality and compliance priorities.
Regulatory and Technical Insight
Our team brings extensive, real-world experience across global regulatory frameworks, including ICH, FDA, EMA and MHRA requirements. We help organisations interpret regulatory expectations, focus on what matters, assess risk and make informed quality decisions with confidence.
Flexible Quality Solutions
From single audits and annual audit programmes to vendor oversight, QA support and inspection readiness, we provide the right support for your objectives and risk profile. Services can be delivered in person, remotely or through a hybrid approach.
Practical. Proportionate. Collaborative.
We believe quality should enable your organisation, not add unnecessary complexity. Working alongside your teams, we bring an objective perspective, provide constructive challenge and help strengthen quality systems through sustainable improvements.