With professional IT expertise
serving the pharma industry for
We have a wide range of experience in the analysis and assessment of the business processes of pharmaceutical manufacturing laboratory organisations involved in pharmaceutical manufacturing and laboratory activities, in the survey and evaluation of IT systems, and also in the compilation of IT strategies and application level conceptual designs.
We offer full life-cycle project management services to our clients, using methodologies employed by the pharma industry (GAMP5, risk assessment based approach).
In the setup and planning phases of projects, we contribute to the compilation of RfP documents, take part in the evaluation of proposals, and the compilation of project definition and conceptual design documents.
In the realisation phase of projects, we provide continuous project management, project administration, quality assurance, and create regular project reports.
We offer continuous professional monitoring of the project phases, and also their technical and quality control according to standards and/or KPI's. Based on our long experience, we provide conflict and crisis management, should it become necessary.
With over 15 years of experience, we can carry out the retrospective or prospective validation of computerised systems, making them suitable ready for GxP audits. We can also verify their 21CFRPart 11 compliance.
In accordance with the risk-based approach of GAMP5, our services cover the planning, management and documentation of the validation project, and also include the planning of the test of the system, as well as supporting and recording the test process.
Our validation methodology and documentation structure have so far been 100 % successful at national and international (e.g. FDA) audits at our clients..
Either as part of validation projects, or independently, we offer the quality focused analysis, documentation and tuning of our clients’ business processes.
Our specialists, relying on their 20+ years of experience in auditing and consultancy, will provide support in designing and establishing quality management systems (QMS), information security management systems (ISMS) and IT service management systems (ITSMS).
Establishing a management systems will include the development of the control environment appropriate to the required standard(s), and training the staff to follow the relevant procedures. If the management system is to be audited by a third party certification body, we can provide the necessary technical support before and during the audit.
Get to know our Annex 11 and 21 CFR Part 11 compliant MES solution, which you can use to electronically record and document your manufacturing processes, and can track the incorporation of raw materials into end products at the package level. The system helps you to comply with the new IDMP requirements, and can also provide data seamlessly to ERP and EBR systems.
Our service related to the implementation of the ARGUS system at your organisation will ensure that the solution will match your business processes and IT environment. As part of our service, we will provide support in reengineering the processes, to maximise your business gain (ROI). We will configure and install the system, provide training and support in the testing and its documentation. A GAMP-based complete validation package is also available as part of our implementation service.
If your requirements exceed the current functionality of ARGUS, we will customise the system and add new functions to it, as necessary. Our development team uses agile methodology and relies on the latest technologies to efficiently provide quality products, and has proved itself at supplier audits.
We provide customisable support service packages for our installed systems, to ensure their continuous and safe operations. The service packages can include - within pre-defined time periods - bug fixes, changes, training, and also consultancy, either remotely or on-site. We can be contacted either through our Help Desk webpage, or over the phone.
Implementation and support of a manufacturing execution system for the Tablet and Injection Plants
Development and validation of a computerised powder dispensing system
ISO9001, ISO27001 és ISO20000-1 auditing and consultancy
Technical support for the GxP compliance of IT systems
Establishing an information security management system for certification against ISO 27001
Auditing and preparing a laboratory information management system (LIMS) for qualification (validation)
Development and operation of an ISO 9001 compliant quality management system
Computerised systems validation related statues outmaking and constituting
Preparation of the application level strategy for a system supporting the submission of regulatory documents
Implementation, validation and support of a dispensing and material tracking system (Russia)
Consultancy supporting the IT implementation of a new facility (Budapest)
Preparation of the application level strategy for an electronic batch recording system
Implementation of a dispensing and material tracking system
Portal development for data sharing
Technical verification of a gas pipeline IT supervisory/control system, as subcontractor to ÁKMI Ltd.
Establishing an information security management system for certification against ISO 27001, as subcontractor to OGYS Ltd.
Compilation of the validation master plan for the SAP ERP system
Survey and evaluation of IT systems supporting the submission of regulatory documents
IT consultancy supporting the establishment of package/packet-level warehouse management
Design of a manufacturing execution system
Implementation and validation of a computerised dispensing system, with an interface to SAP
Further development of a Documentum based regulatory document management system with SAP interface
Implementation of a document management system for drug development, based on Documentum 4i
Development and validation of a computerised dispensing system
Development of a computerised dispensing system
Development and validation of a computerised dispensing system
Development of a raw material dispensing system
Establishing an information security management system for certification against ISO 27001
Documenting the user requirements of a dispensing and manufacturing execution system
Training related to quality assurance (validation of IT systems)
Requirements analysis for a manufacturing execution system, and preparation of the feasibility study document
Survey and evaluation of open-source document management systems, related consultancy
SIGNUM Ltd. was founded in 1990, with the strategic aim, right from the beginning, to deliver state-of-the-art IT systems, and to provide high quality solutions and services that always fulfill the specific requirements and expectations of our customers, thereby ensuring their ((complete)) satisfaction.
...we aim to establish and maintain continuous and fair supplier-customer relationships with our partners,
...we continually improve the level of our professional activities in the areas of requirements analysis, project planning, system design, implementation, installation and support,
...we pay attention to the selection and use of suitable methodologies,
...we ensure the use of IT technologies that match the given task, and we also develop the IT infrastructure as necessary.