LabArchitect™ is HH Global Holdings' complete eight-module laboratory deployment system. We design, equip, and validate regulated laboratories, ISO 17025/15189-compliant from inception, not retrofitted. One partner. One accountability line. From governance and infrastructure through to digital systems, quality control, and defensible reporting.
Compliance by Design · Not Retrofit · One Partner · Full Accountability
First on a budget. Then again, painfully, when accreditation auditors arrive and the documentation, traceability, and quality systems don't hold up. Retrofitting ISO 17025/15189 onto a working laboratory is the most expensive mistake in regulated science.
LabArchitect™ inverts the sequence. We build the governance, validation, traceability, and reporting architecture before the lab opens, so accreditation is the natural endpoint of how the lab already operates, not a separate project bolted on later.
Each module is a self-contained workstream with defined deliverables, validation steps, and accountability. Together they constitute a complete, audit-ready laboratory.
Quality manual, organisational structure, role accountabilities, document control framework, and management review architecture.
Floor planning, equipment specification, environmental controls, calibration schedules, and supplier qualification protocols.
Standard operating procedures, method validation, technical procedures, and training matrices, every workflow documented and verified before deployment.
End-to-end sample lifecycle controls, receipt, chain of custody, storage, retention, and disposition, with full audit trail integrity.
LIMS architecture, electronic record systems, data integrity controls, instrument integration, and 21 CFR Part 11-aligned audit trails where required.
Internal QC schedules, proficiency testing, inter-laboratory comparison, non-conformance handling, and corrective action frameworks.
Report templates, uncertainty statements, opinion frameworks, and customer communication protocols, court-admissible and regulator-ready.
Internal audits, management review cycles, accreditation submission packs, and continuous improvement architecture compliant with ISO 17025/15189.
LabArchitect™ is judged on the operational reality it creates, not the documentation it ships.
Not a lab that becomes audit-ready six months after opening. ISO 17025/15189 is the operating model, not a future project.
Every method validated. Every result traceable. Every report defensible, in audit, in regulator review, and in court.
No subcontractor handoff gaps. No "that's the architect's problem, not mine." Single team, single accountability line.
Your scientists are inducted on the SOPs, workflows, and digital systems that LabArchitect™ deploys, not on generic frameworks.
The submission pack is built as a by-product of how the lab already operates. Accreditation becomes a milestone, not a rebuild.
Building right the first time is materially cheaper than retrofitting, in capital, in time-to-revenue, and in scientific reputation.
LabArchitect™ is for institutions that need their first lab to be their last lab, built right, accredited cleanly, defensible from day one.
Standing up new diagnostic, pathology, or specialised testing facilities, ISO 17025/15189 compliance from inception, with infection-control and CQC-ready documentation.
Translational research labs, spin-out diagnostic facilities, and core service units that need to operate to commercial accreditation standards from day one.
National laboratory capacity-building programmes, public health testing, food safety, environmental monitoring, and reference labs, delivered turnkey with full documentation transfer.
Independent clinical and analytical labs entering regulated markets, accreditation as a market entry requirement, not a future ambition.
Forensic toxicology and specialist diagnostic laboratories where defensible methods and chain-of-custody integrity are non-negotiable.
Companies establishing internal analytical capability or contract testing facilities compliant with ISO 17025/15189, one integrated build, full validation pack.
A structured deployment process, gated, documented, and tracked against the eight-module framework at every stage.
Capability requirements, scope of accreditation, regulatory frame, budget envelope, and timeline. We map your end-state and reverse-engineer the build.
Floor plans, equipment specifications, governance pack, SOPs, and validation protocols. Every module designed before the first instrument is purchased.
Lab fit-out, equipment installation, system commissioning, method validation, and staff training. Each module signed off against its acceptance criteria.
Accreditation submission pack, pre-assessment readiness, mock audit, and on-site support during UKAS or equivalent assessment visits.
Accreditation maintenance, internal audit cycles, document review, and regulatory horizon scanning, all delivered as a continuous partnership rather than a one-off engagement. Available as an ongoing tier once the initial build completes.
Annual internal audit programme, management reviews, and proactive non-conformance resolution, keeping the QMS live.
Scheduled validation reviews, SOP refresh cycles, and document control oversight aligned to your accreditation schedule.
Early visibility on standard updates, regulator guidance, and industry developments, with impact assessments and upgrade paths.
LabArchitect™ is led by scientists who have built, run, and accredited regulated laboratories themselves, not by consultants reading from a template.
Government advisory committees. Clinical trials with AstraZeneca. The scientific foundation underpinning every LabArchitect™ deployment.
15+ years in translational research, diagnostics development, and laboratory operational leadership. Honorary Associate Professor, University of Nottingham. Architect of the eight-module framework, built from direct experience standing up regulated lab capability.
If you're standing up a regulated lab, clinical, forensic, analytical, or research, we'd welcome a conversation about scope, timeline, and accreditation pathway. Initial consultations are free of charge and confidential.
Email the Team → Other Ways to Reach Us