This document is written in plain English. If anything is unclear, contact [email protected].
In short: VipLIMS helps laboratories record, organise, report and audit their work. It does not diagnose, interpret results or make clinical decisions, and it is not a medical device. Clinical decisions remain with qualified professionals. Every laboratory remains responsible for its reports, its reference ranges and templates, validating VipLIMS for its own use, and its accreditation.
Version 1.0. Effective date: 13 October 2026.
1. What VipLIMS is
VipLIMS is a laboratory information management system. Its intended purpose is to store, organise, display and transmit information that laboratory staff enter, and to support laboratory workflow: registering cases, assigning work, writing and authorising reports, tracking turnaround times and keeping an audit trail.
2. What VipLIMS does not do
2.1 VipLIMS does not:
- diagnose any condition;
- interpret test results or images;
- decide whether a result is clinically significant;
- recommend treatment or any other clinical action;
- release results automatically without a person authorising them.
2.2 Every report is written, checked and authorised by people at the laboratory. Features such as flags against a reference range, coding look-ups and synoptic forms compare or organise information against content that the laboratory itself configures and controls. They are aids and do not replace professional judgement. Clinical decisions remain with appropriately qualified healthcare professionals.
3. Not a medical device
3.1 Based on its intended purpose, VipLIMS is not a medical device or an in vitro diagnostic medical device within the meaning of the UK Medical Devices Regulations 2002 (as amended), or of Regulation (EU) 2017/745 or Regulation (EU) 2017/746. It is software for storing, archiving, communicating and organising records, and it does not provide information used to make diagnostic or therapeutic decisions by calculation, interpretation or analysis of its own. It is not UKCA or CE marked, and it must not be used as if it were a device for diagnosing, preventing, monitoring or treating disease.
3.2 If a laboratory configures, extends or connects VipLIMS in a way that could change that status, for example by building automated rules that interpret or release results, the laboratory is responsible for assessing and meeting any resulting regulatory requirements.
4. NHS clinical safety standards
VipLIMS has not been assessed against the NHS clinical risk management standards DCB0129 and DCB0160. NHS and other health organisations that deploy VipLIMS are responsible for their own clinical risk management, including any DCB0160 assessment, data protection impact assessment and Digital Technology Assessment Criteria (DTAC) review. We will provide reasonable information to support those assessments; contact [email protected].
5. The laboratory's responsibilities
Each laboratory that uses VipLIMS remains fully responsible for:
- Clinical content. The accuracy, completeness and clinical meaning of every report it issues, including supplementary reports.
- Reference ranges, units and templates. Making sure the ranges, units, report templates, synoptic forms and codes it uses are correct and appropriate for its methods and population.
- Validation and verification. Validating or verifying VipLIMS for its intended use before using it for live work, and after significant changes, in line with the standards that apply to it, such as ISO 15189 for medical laboratories and ISO/IEC 17025 for testing laboratories.
- Accreditation and regulation. Meeting the requirements of its accreditation body, regulators and professional guidelines, including record retention.
- People and access. Making sure only competent, authorised people write and authorise reports, and that roles in VipLIMS reflect that.
- Checking outputs. Checking that reports, PDFs, Word documents and other outputs are correct before relying on them, and that they reach the right recipient.
6. Speciality packs and sample content
VipLIMS provides speciality packs for different laboratory types. These may include sample case types, test lists, reference ranges, report templates and synoptic forms. This sample content is illustrative only. It is a starting point that the laboratory must review, adapt and verify before use, and it is not a substitute for current professional datasets, guidelines or manufacturer information.
7. Demonstration data
The optional demonstration data offered during onboarding is synthetic. It does not relate to real people, and any resemblance to real patients is coincidental. Remove it before going live, and never use it as a basis for clinical decisions.
8. Terminology
VipLIMS includes terminology packs such as a SNOMED CT subset, LOINC, UCUM and ICD content, and lets laboratories import others under their own licence. The laboratory is responsible for choosing and applying codes correctly. See Terminology notices.
9. Validation help
We can help laboratories plan and document their validation as an optional paid service. That help supports, but does not replace, the laboratory's own responsibility for validation.
10. Liability
Our liability is set out in the Terms of service. In particular, we are not liable for clinical decisions, diagnoses or reports made or issued by a laboratory. Nothing in this disclaimer limits liability that cannot be limited by law.
11. Reporting a safety concern
If you notice behaviour in VipLIMS that could affect patient safety, report it straight away to [email protected] and, if it may be a security issue, to [email protected]. Include enough detail for us to reproduce it, but do not send real patient data.