Many consultants understand validation requirements. Others understand laboratory operations. Fewer have experience of both.

T-Regs Consulting Ltd was founded by a laboratory scientist and former GLP Study Director who has worked directly with the systems, data and processes now supported through consultancy. This practical background enables effective collaboration between laboratory users, quality functions, IT teams and software vendors.

We specialise in laboratory informatics and computerised system validation within GxP-regulated environments, with particular expertise in Waters NuGenesis SDMS and LMS. Whether supporting a system implementation, upgrade, data integrity initiative or validation programme, our focus is on delivering solutions that are operationally effective, compliant and sustainable beyond project completion.

Examples of recent and past engagements include:

• Computer system validation (CSV) for laboratory informatics platforms, including LIMS, ELN and scientific data management systems (SDMS)

• Waters NuGenesis implementation, administration, upgrade and customisation projects

• Design and validation of paperless laboratory workflows to support digital transformation initiatives

• Data integrity assessments, audits and remediation planning for computerised systems and laboratory processes

• Development and review of validation documentation, including requirements specifications, risk assessments and IQ/OQ/PQ protocols

• Independent or embedded project leadership for laboratory informatics programmes, supporting requirements gathering, vendor management, validation, testing, deployment and business adoption activities

The precise scope of support is tailored to the organisation, system landscape and regulatory requirements of each engagement.

Both.

Some clients engage T-Regs Consulting Ltd for independent advice on validation strategy, data integrity, system selection or inspection readiness. Others require hands-on support with requirements gathering, validation documentation, testing, system administration or project delivery.

The level of involvement is tailored to the needs of the engagement and can range from short-term advisory support to embedded project delivery.

Yes. Although T-Regs Consulting Ltd has particular expertise in Waters NuGenesis, support is not limited to a single platform. We can assist with broader laboratory informatics initiatives involving LIMS, ELN, SDMS and related laboratory systems, providing project leadership, validation support, stakeholder engagement and compliance expertise across the system lifecycle.

Yes. Our clients range from global pharmaceutical manufacturers to small CROs and laboratory software vendors. The approach is tailored to the scale and regulatory context of the organisation.

Yes. We are accustomed to operating within client quality management systems and can work under a quality agreement where required. All deliverables are produced to audit-ready standards.

Yes. We support clients globally and offer remote and hybrid (on-site) consultancy according to the requirements of the engagement.

Please use the contact form‍ to outline your requirements. We will arrange an initial consultation to understand your needs, the regulatory context and the scope of the work before proposing an approach.

Current availability for new consultancy engagements is from September 2026. Early discussions regarding future requirements are welcome.

Our fees depend on the scope, complexity and duration of the engagement, together with any agreed travel arrangements. We offer transparent pricing with flexible engagement models, from short-term advisory work to extended project support.

T-Regs Consulting Ltd is a UK VAT-registered business and has a strong preference for contract engagements outside IR35.