Certifications
Quality and Information security
Certifications of our integrated management system, consisting of the information security system (ISMS) and the quality management system (QMS), guarantee software solutions at the highest level. International standards and the strictest security requirements are adhered to and monitored annually by external auditors. For our customers, this means:
- Higher product quality: Continuous review and optimisation of our processes lead to consistently high-quality software solutions.
- Efficient processes: Clearly defined processes and responsibilities enable us to respond more quickly and precisely to your requirements.
- Customer satisfaction: At our core, we are committed to your satisfaction. Our feedback loops ensure we not only know your needs and expectations but also meet them, making you feel valued and important.
- Climate protection: Every certified company is mandated to be concerned about environmental issues. As a software company, we take climate protection seriously and contribute to saving our planet through innovation and ingenuity!
- Confidentiality, Integrity, and Availability: The three pillars of information security ensure that your data is optimally protected.
- Risk Management: Our thorough risk assessments and the subsequent implementation of appropriate measures ensure that potential threats are identified and mitigated, providing you with a safe and secure working environment.
- Change Management: Changes are implemented in a controlled and documented manner. Mandatory top management approval ensures that every change is implemented following regulations.
- Business Continuity: Our comprehensive contingency planning ensures that we are prepared for any emergency, providing you with a secure and stable work environment.
- Compliance: We are aware of and comply with all relevant legal requirements, especially those regarding personal data protection.
- Continuous improvement: Ongoing reviews ensure we regularly evaluate and improve our integrated management system.
- Training and Awareness: Our entire team’s security awareness is essential to the conduct of our business. Each individual receives regular training on information security and the importance of protecting information.
aiti GmbH certifications
Why a certified Software provider is the better choice
- Regulatory compliance: Not only GxP companies must meet strict regulatory requirements. Software used in these and similar areas must comply with these requirements to meet all legal requirements. This includes directives and regulations of the European Commission, EMA (European Medicines Agency), national authorities (Federal Institute for Drugs and Medical Devices (BfArM) in Germany), the FDA (21 CFR Part 11) in the USA, and similar regulations worldwide.
- Efficiency and reliability: Good software saves time and money by working efficiently and reliably. This is particularly important in manufacturing and research, where time is often critical.
- Data integrity: GxP companies work with sensitive and often vital data, which must be guaranteed to be always intact. High-quality software protects this data from loss, manipulation, and unauthorized access.
- Safety and patient welfare: Patient safety is paramount in areas such as pharmaceuticals, medical devices, and biotechnology. Software errors can have serious consequences, from incorrect laboratory data to life-threatening situations. High-quality software minimises these risks through thorough testing and validation.
