Research Institute of Organic Synthesis (VUOS)

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 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.

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.