Research Institute of Organic Synthesis (VUOS)

Company introduction

VUOS is engaged in the R&D, up-scaling and production of chemical specialties, custom syntheses and analytical and toxicological testing. The VUOS Testing Center – Center for Ecology, Toxicology and Analytics holds the GLP and GMP (SÚKL) certificates, ISO 17025 accreditation and the ISO 9001 certification.

VUOS operates in the area of pharmaceuticals, microelectronic, and other high performance organic chemistry.

Reasons for the new VUOS LIMS

  • Digitalization and paperless laboratory. Easier results sharing.
  • Data integrity and security. Avoiding working with uncontrolled documents and files (MS Office)
  • Easier searching and filtering across documents and records
  • More efficient data processing, incl. financial reporting


The first step in the LIMS implementation was creation of a User Requirements Specification and contacting potential suppliers, followed by a tender and a contract closure. The delivery began with a detailed analysis of user requirements and configuration workshops with future users. Based on these meetings and analyzes, a test environment was created in which the requirements were fine-tuned and agreed. Subsequently, the application was validated, users were trained and operation was started in a production environment

Key requirements from URS

  • The new LIMS will ensure a complete laboratory and quality management, embracing company documents and laboratory records
  • The system is required to meet the quality and compliance requirements, including data integrity/audit trail and software validation
  • The quality systems to be covered are: GMP, GLP, ISO 17025 and ISO 9001

The original URS included 403 requirements broken down into functional requirements and other requirements. The functional requirements included system requirements, laboratory management and quality management, incl. deviations and change controls. In the next phase, the project was extended based on a separate URS, covering document management and training for the entire company.

Basic data

Number of users: a total of 250, concurrent: 50

Number of modules: 63

Number of workflows: 43

Number of user roles: 78

Number of primary records in database (Samples, Results, Documents, ..):> 30 thousand / year

Number of related records in database (History and Audit trail):> 150 thousand / year

Scope and project phasing

Phase 1: Laboratory Management (LIMS)

Samples, Results, Specifications, Equipment, Reference materials, Methods, Columns, Solutions, Material items, Chemicals, sampling, re-testing, managerial reporting.

Note: general functionalities have been implemented within Phase 1: data security and integrity, incl. filtering, searching, export/import, printing, etc.

Phase 2: Controlled documents and training (DMS and LMS)

Controlled documents, training, tests, test questions, test replies, escalation for non-complying tests, notification to the message center and by e-mail

Phase 3: Quality management and stability studies (QMS and STAB):

Deviations, change controls, CAPA management, complaints, OOX, Stability studies

Phase 4: Statistical data evaluation (STAT):

Method validation, control charts, uncertainties, inter-laboratory comparison, total 51 algorithms; processed according to the scheme: Data> Acceptance criteria> Results> Graphs> Report > Summary reports

The implementation of all 4 phases took about 2.5 years. Subsequently, the system passed ISO 17025 accreditation, GMP inspections and customer audits.

Customer benefits - VUOS

  • Compliance with ISO 17025 and GMP requirements (EMA) – readiness for audits and inspections, high data security and compliance with data integrity/audit trail and software validation requirements
  • All lab agendas, quality management and documentation management centralized in one place, handled paperless. Continuous system availability and data traceability guaranteed.
  • Easy filtering and searching across documents and records (according to metadata and full-text)
  • User friendly for all personnel, regardless of the function
  • 24/7 availability from anywhere and for anyone with the corresponding user privileges

Compliance with regulatory requirements for electronic systems

The system was delivered and implemented in accordance with the applicable requirements on electronic systems for ISO 17025 accredited laboratories and GMP certified companies, in line with:

  • GAMP 5
  • Annex 11 EU GMP (data integrity, audit trail)
  • CFR Part 11 El Records and Signatures
  • ISO 17025

Examples application screen-shoots


Základní Pracovní plocha

Samples and Results Module

Modul Vzorky a Výsledky

Controlled documents and Training module

Modul Řízené dokumenty