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.
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
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.
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
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.
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: