References
Aventis (Germany, UK)
SAP test support
Objective: Perform tests on schedule and in compliance with regulatory bodies
Description: Coordinate the creation of test specifications, perform reviews and monitor the execution of tests.
LIMS implementation support
Objective: Additional developments for SQL*LIMS
Description: Develop interfaces and put them into service.
Bachem (Switzerland)
Computer validation master planning
Objective: Cost estimate and project definition for establishing compliance
Description: Clean up the system inventory, perform assessments, draw up alternative solutions, plan activities with a cost estimate.
Doetsch Grether (Switzerland)
Feasibility study for LIMS implementation
Objective: Decision-making basis for the management team
Description: Analyse the processes, explain the benefits of an LIMS, and describe the project scope, the main requirements, project planning, costs, benefits, etc.
Document management
Objective: Manage guided documents
Description: Draw up a concept for document management, implement PDE (document management).
ERP validation
Objective: Implement an ERP system that complies with regulatory requirements
Description: Provide validation consulting and implementation, draw up validation documents, test planning and monitoring, and devise SOPs.
Essex Animal Health (Germany)
LIMS validation
Objective: LIMS implementation that complies with regulatory requirements
Description: Provide validation consulting and implementation, draw up validation documents, test planning and monitoring, and devise SOPs.
Hesperion (Switzerland)
Validation consulting
Objective: Draw up basis for computer validation
Description: Devise a concept, guidelines and a master plan.
CDMS validation
Objective: CDMS implementation that complies with regulatory requirements
Description: Provide validation consulting and implementation, draw up validation documents, test planning and monitoring and devise SOPs.
The Institute of Virology and Immunoprophylaxis (Switzerland)
LIMS feasibility study
Objective: Decision-making basis for the management team
Description: Analyse the processes, explain the benefits of an LIMS, and provide a report on the project scope, the main requirements, project planning, costs, benefits, etc.
LIMS implementation
Objective: Implement LabWare LIMS
Description: Draw up requirements and specifications, pilot, training, validation, start-up.
State Laboratory of the Canton of Basel (Switzerland)
LIMS migration support
Objective: Migration of SQL*LIMS
Description: Install and roll out a new release of SQL*LIMS
Merial (France, U.S.)
Global LIMS concept
Objective: Decision-making basis for the management team
Description: Analyse the processes and systems, etc. in several companies, identify potential for improvement and harmonisation, plan an LIMS project in a multi-site environment, and prepare the decision-making basis for the management team.
Global LIMS implementation
Objective: Implement an LIMS at several sites in France and the U.S.
Description: Implement a LabWare LIMS at several companies – in both the R&D departments and production. This includes, e.g. project management support, concepts, validation, report programming.
MDS Pharma Services (Switzerland)
Validation consulting
Objective: Draw up basis for computer validation
Description: Devise a concept, guidelines and a master plan.
LIMS validation
Objective: LIMS implementation that complies with regulatory requirements
Description: Provide validation consulting and implementation, create validation documents, IQ, OQ, PQ.
Novartis (Switzerland)
Quality Management project for a global IT infrastructure
Objective: Ensure compliance in a global infrastructure project
Description: Provide consulting to ensure compliance when introducing a company-wide infrastructure project (desktop).
Laboratory information management strategy
Objective: Draw up a global IT strategy for quality assurance areas
Description: Analyse processes, systems and data, perform evaluations, draw up alternative concepts and business cases, and create a strategy and system of communication.
SOP revision
Objective: Implement up-to-date SOPs that comply with regulatory requirements
Description: Revise all SOPs in a large department, conduct interviews, agree content, draw up documentation.
Organon (Germany, Netherlands)
Organisational study
Objective: Draw up alternative designs
Description: Analyse framework conditions and future scenarios. Devise alternative solutions
Part 11 Compliance
Objective: Validate all the systems of an analytical laboratory
Description: Organon operates a fully automatic services laboratory that manages and approves analysis data in an LIMS. The systems were validated and later tested to check whether they met the requirements of 21 CFR Part 11. Measures were then defined and implemented.
Master planning for the Part 11 Compliance project
Objective: The activities and reports conducted by Livec make it possible to plan and budget the project reliably and in detail and offer greater reliability in official audits.
Description: The degree to which the requirements of 21 CFR Part 11 were met by the computer-aided systems used by eight departments was recorded. A gap analysis (assessment report) was drawn up for each department. This analysis forms the basis for consolidation and prioritisation of the planned measures. The report lists possible activities; the risks resulting from the gaps were evaluated and the costs estimated.
Kapazeit
Objective: Development of a study management system for capacity planning
Description: Livec implemented an extension to the study management system for capacity planning and time recording. The software was designed and developed based on customer-specific requirements.
ARCS (Automated Release Control System)
Objective: Development of a fully automatic laboratory solution for long-term studies.
Description: Development and implementation of a system for controlling laboratory robots and automatic samplers, automatic execution of measurements and evaluation of measurement data.
Philip Morris Research Laboratories (Germany)
LIMS project study
Objective: Create a decision-making basis for the management team
Description: Record current scenario, perform analysis and suitability check, draw up a concept, and identify key requirements which are handed over to suppliers.
Roche (Germany, Italy, Switzerland)
Computerized Maintenance Management
Objective: Project study, concept and requirements
Description: Record requirements, create a concept for the CMMS (Computerised Maintenance Management System), define the project.
Computer validation master planning
Objective: Cost estimate and project definition for establishing compliance
Description: Clean up the system inventory, perform assessments, draw up alternative solutions, plan activities with an estimate of work involved.
Maintenance LIMS
Objective: Provide support for an LIMS, know-how transfer
Description: Provide comprehensive support for an LIMS with know-how transfer to internal employees. The support provided was both remote and on-site. System expertise and knowledge of the internal processes and conditions were key to providing a good service.