Know-How in Automation and IT combined with Years of Experience in Critical Processes
Your Critical Processes are in Good Hands
anapur handles complex security solutions tailored to fit the specific requirements of different sectors and companies. The company portfolio covers the entire life cycle of automation and production data systems – from consulting of operator requirements up to operation and maintenance.
anapur combines know-how and experience in automation and IT while meeting high demands in quality and security. We aim for the highest optimization and security of your productivity. You can benefit from our know-how in handling safety-related tasks: We have proven our expertise in numerous projects for well-known customers.
We Help you Achieve GMP Compliance for Your Computer Systems
According to Annex 11 of the EU GMP guidelines, computer systems need to be validated and IT infrastructure has to be qualified. The question, however, is how to achieve this with reasonable expense. Over many years, anapur has built significant know-how in the area of validation and qualification of pharmaceutical systems. We offer solutions tailed to meet your demands for reaching GMP compliance.
Our GMP services:
- Creation of qualification and validation documentation
- Validation master plan
- Risk assessment
- Qualification plans
- Qualification test protocols
- Qualification reports
- Implementation of qualification measures (DQ, IQ, QQ, PQ)
In the following areas:
- Automation systems in pharmaceutical production and packaging plants
- Laboratory and monitoring systems
- IT systems in blood banks
- Hospital pharmacies
Safety according to IEC61508/61511
Industrial plants can endanger human lives and threaten the environment. Functionally safe systems contribute to the overall safety and thus to a reduction of these risks.
For more than 15 years, our technically certified staff has been in charge of security system projects for onshore and offshore plants, gathering stations, refineries, incineration plants and fertilizer plants.
We support you in:
- Set-up of an FS management system
- Facilitation risk assessment
- Elaboration of concepts
- Customizable standard solutions, such as EDP, fire incident matrix
- FAT, IFAT
- start of operation
- Petrochemistry, chemistry
- Building technology (smoke extraction and fire safety)
Control of Cross-Disciplinary IT Security Projects
- Whether it is energy production, wastewater processing, production or health services – corrupt IT networks or automation systems have undesired impacts on the regular process operation with (often unforeseen) consequences.
- Nobody knows when and how often such events may occur.
- Big or small – the budget for measures has to be applied diligently. What’s the point of a door lock if the window is wide open?
anapur helps you get security to a level where every cent invested in security comes fully into effect. You benefit from our knowledge of requirements in the area of operational technology and our know-how of analysis and implementation of cyber security measures. In this, we assume the status of a neutral third party and lead cross-disciplinary security projects to a successful finish. Particularly in those fields where security and functional safety or security and GMP overlap, you can rely on our know-how of the relevant compliance requirements.
Our IT Security Services:
- Capacity building in the context of IT security law
- Evaluation of Security for Safety
- Performance and facilitation of risk assessment
- Evaluation of existing plants and systems
- Planning, monitoring and implementation of technical measures
- Planning, monitoring and implementation of organizational measures
- Assessment and test of security products
- Existing sites
- Future projects
- Individual systems or plants
- Prototype solutions
Experts for Your Infrastructure and Your Network
The IT infrastructure needs to be adjusted to the requirements of the operation environment. It is supposed to make your work easier, not to create extra work. We support you during your infrastructure projects and take care of a secure operating procedure.
- Assessment of your existing infrastructure and network connectivity
- Consulting with respect to hardware and software purchases
- Planning, implementation and documentation of infrastructure projects
- Backup strategies
- Patch management
- Anti-virus and firewall concepts
- Monitoring of your infrastructure
- Remedy of defects within your infrastructure
Project management and coordination
Project Management in Pharmaceutical Production and in the Health Sector
Projects may often have considerable effect on the company organization that is targeted at the production of goods or the care for patients. IT projects are particularly affected by the additional challenge of the „intangible“ subject of the project. If, on top of that, there are specific regulatory requirements to the project handling and the project subject to be considered, such as GMP (Good Manufacturing Practice), the entire project organization – from the supplier to the technical staff to the end user – is facing a challenge that should be met with cross-disciplinary know-how and structured, systematic methods.
- Program/project management skills (e.g. qualification according to IPMA)
- Experience in the handling of complex IT projects and
- profound, sector-specific know-how (e.g. of processes and regulations)
anapur offers a comprehensive management – from small projects up to programs – securing the implementation of the project in time, in budget and with the expected quality. Major aspects are
- Definition and specification of user requirements
- Selection of suppliers, taking into account the specific boundary conditions
- Reconcilement of objectives and non-objectives among the different stakeholders
- Planning of the project structure and method, taking into account all organizations involved in the project
- Transparency in project handling and with respect to status, progress, risks and problems towards the decision makers and the entire project organization
- Clear and comprehensible project change management
- Project management documentation according to international standards
- Taking into account the post-project phase (operation) already at the start of the project
Apart from the obvious, purely (IT) technical activities, the project may focus on the following topics:
- Qualification/validation on the customer/supplier side
- Organizational and technical interfaces for project and operation
- IT infrastructure
- Organizational regulations for operation
- Ensuring the successful passage from project phase to operation phase
Customers trusting in anapur
ABB, Airbus Cassidian, Advenica, AGT, Allgemeines Krankenhaus Wien, alphatron, AREVA, Axima Suez, Bacon, BASF, Baxter, Bayer, Bilfinger, Boehringer, Camfil, Cegelec, Deloitte, EnBW, Endress & Hauser, Exxon, Grace, Hewlett Packard, HIMA, Honeywell, Infraserv, Innominate/Phoenix Contact, Intervet, ISC, Johnson Controls, Kamstrup, Krankenanstaltenverbund Wien, Kiesel, KPMG, Laborelec, Lanxess, Lenzing, Mann+Hummel Protec, Max-Planck-Institut für Kernphysik, Neuberger, Nextnine, NTTCom, Nycomed, ÖQmed, OMV, Otto, PaloAlto, PA-Solutions, PLT-Networks, Procter & Gamble, Roche, Rösberg, Sanofi, SANS, Sauter Controls, Secuvera, Seibersdorf Laboratories, Sentryo, Siemens, Swan, Tetra, TÜV, VTU, Waterfall, Westinghouse, Yara, Yit.