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Digital, modular, sicher:
QMS für die Biotech-Zukunft
Our QM software creates the essential framework for modern biotech. We integrate specialized biotechnological workflows with cutting-edge software solutions, supporting you from lab-scale planning to final quality control.
Rely on innovative quality assurance methods to confidently meet regulatory requirements. We support you every step of the way—from initial setup to the seamless validation of your QM systems.
Digital, Modular, Secure:
QMS for Future-Proof Biotech
Biotech companies trust our QM software
We understand the challenges biotechnology companies must overcome when implementing standards such as GMP (Annex 15/16), 21 CFR Part 11, and GAMP 5. From the laboratory to the finished biotechnological product – we support you in mapping complex processes such as characterization, storage, and critical testing for genetic stability or viral safety in compliance with ICH Q5.
Process validation and monitoring
Traceability for cell banks and cell cultures
Documentation of subculturing, media, and culture conditions
Cleaning and sterilization validation (CIP/SIP)
Supplier qualification
In biotechnology, the integrity of your cell lines is the foundation of all successful research and production. Our digitally supported quality management provides you with a practical solution to ensure the seamless traceability of cell banks and cell cultures.
Biotech production companies
As a contract development and manufacturing organization in life science, you must navigate a dual landscape: satisfying rigorous client specifications alongside complex GxP regulatory mandates. Our digital QM software provides the necessary infrastructure to bridge these requirements.
Order and contract management
Qualification of clients and suppliers
Audit-ready cell bank management
Batch traceability
We understand that a biotechnology contract manufacturing organization requires maximum flexibility combined with the highest level of security. From initial research to final manufacturing practice, our system supports you in efficiently managing multi-client workflows while ensuring the quality of every single batch.
Contract manufacturers
Especially for biotechnological products that demand extreme precision in handling and temperature control, seamless quality management in logistics is vital. Our digitally controlled systems offer a practical solution to ensure the continuous efficacy of your cold chain.
Documentation of storage and transport
Seamless temperature logs for cold chains
Deviation management and CAPA
Audit trails and qualification of transports
We support you in implementing GDP guidelines and EU GMP Part II. Effortlessly meet the requirements of 21 CFR Part 11 and Annex 11 through ALCOA+ compliant data integrity and immutable audit trails.
Biotech logistics providers
Our software is the critical building block for success in biotech trade and distribution. Our solution ensures that the quality of your biotechnological goods is maintained throughout the entire journey to patients.
Batch management and traceability
Supplier qualification and audits
Electronic signatures for commercial processes
FMD-compliant serialization for biopharmaceuticals
Master the implementation of EU GDP guidelines and falsified medicine prevention (FMD). Whether it is the storage or transport of cell banks and biocultures—ensure the efficacy of sensitive biopharmaceutical products.
Biotech trade and distribution
Biotech-Exzellenz durch spezialisiertes QMS
Many reasons, one solution: Why biotech market leaders choose us.
Ensure regulatory compliance
Implement GAMP 5-validated QM solutions
Automate QM workflows and biotech processes
Secure data integrity in Research and Development
Utilize user-friendly and scalable QM modules
Master audits and accreditations with ease
QM Software for Biotech Conquers Compliance Traps
In the demanding life sciences and biotechnology sectors, we have a deep understanding of complex regulatory requirements.
Our software was specifically developed for companies in biotech and biopharmaceutical production that operate under strictly regulated conditions and must ensure seamless documentation and quality control. At its core is a consistent alignment with GMP.
Our solution helps map standards, guidelines, and internal procedures in a way that allows you to demonstrably guarantee regulatory compliance and legal requirements while maintaining audit-ready documentation.
Our digital systems support your company in the legally compliant implementation of GMP, 21 CFR Part 11, and GxP. We ensure the safety of your products at all times through seamless documentation, validation (IQ/OQ/PQ), and efficient laboratory processes.
Ensure immutable documentation and access controls for FDA/EMA compliance. Future-proof your quality management strategy and transform regulatory hurdles into a distinct competitive advantage by leveraging our solution.
Find out how we can take your biotech QM processes to the next level.
Contact us today for a live demo!
Biotech without the paperwork – thanks to digital quality management
Our solution offers the necessary flexibility for any biotechnological environment. Replace manual sources of error with digital documentation, immutable audit trails, and electronic signatures for the highest level of data integrity. By digitally transforming your quality assurance, tedious document searches become a thing of the past. A modern quality management system ensures that valid data is accessible at any time and plays a central role in optimizing processes.
This is especially critical in a biotechnological environment: We support you in the development and implementation of systems that guarantee seamless traceability of batches and cell banks. Our focus lies in ensuring the highest standards while taking your individual requirements into account.
Our software solution helps you evaluate current trends and transform technical fundamentals into efficient workflows.
Upscale Biotech Processes through Smart QM Functions
A biotechnology company needs more than just standard tools. Our software offers industry-specific flexibility tailored precisely to the needs of a biotech laboratory. Whether it is audit management, training management, or change control – we support you in your daily operations. Our system includes all the tools required for modern management and ensures security during every audit.
Our platform includes features for risk-based auditing, change control, CAPA, deviation management, and release workflows to continuously ensure the effectiveness of your production processes and systems. Our solution is designed to flexibly integrate existing systems and workflows, enabling a step-by-step transition to digital, end-to-end quality management.
Boost Efficiency with Our Top Features for Biotech
Integrated document control
SOPs and version control
Deviation management and CAPA
Change control
Traceability of batches and cell banks
Electronic signatures and approvals
Integration into biotech workflows and IT Systems
Training management and skill matrix
Elektronische Signaturen und Freigaben
Each module can be flexibly adapted to your specific needs – from quality control to ensuring compliance.
Secure control of quality-relevant documents: Ensuring your documentation always remains audit-proof.
Structured process modeling for transparent quality management in the biotech industry.
Integrated training management and LMS.
Tailored Services For Your Success
We won’t leave you to handle it alone: From the initial requirements analysis to full implementation, we support you in taking your quality management systems to the next level.
We don’t just implement; we optimize. As your dedicated partner for QM software and services, we continuously evolve your system landscape. Through integrated training and hands-on webinars, we empower your team for the future.
For further information or a personalized consultation regarding the implementation, please feel free to contact us.
To sustainably optimize your quality management, we offer the following services:
Introductory workshops
Individual consulting
Maintenance and updates
Expert service and support
Key-User training and coaching
Webinars and continuing education
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Our FAQ answers your questions about using specialized QM software in the biotechnology industry.
For a biotechnological laboratory, you should first understand the fundamentals of your quality management, research, and pharmaceutical applications, and clarify which regulatory requirements (e.g., GxP, ISO 17025, ISO 15189) the software must guarantee. Look for a digital QMS that encompasses document control, training and CAPA management, audit trails, validation, and the specific procedures used in microbiology, biotechnology, and pharmaceuticals to ensure all processes remains transparent and traceable.
Our software features integrated compliance functions that ensure regulatory security by encompassing standards such as GMP, GAMP 5, ISO 15189, and 21 CFR Part 11 for biotech management.
Our software supports the digitalization of quality processes in biotechnology companies by building on proven foundations for the life sciences industry. In the biotech environment, it facilitates the development of digital methods for quality assurance and quality control specifically tailored to pharma-like requirements. Through our modular Quality Management System (QMS), companies can standardize and evaluate processes while ensuring legal compliance—a factor of critical importance in the industry. Current technical capabilities include ensuring audit trails and automated document control, allowing general questions regarding GMP and ISO compliance to be resolved efficiently. With sophisticated modules for risk management and CAPA processes, our solution optimizes quality assurance and promotes a proactive role in digital transformation.
Biotechnological quality management systems differ from standard solutions through their specific adaptation to the regulatory requirements of the biotechnology industry, whereas standard solutions serve generic processes without a GxP or pharmaceutical focus. By incorporating integrated validation (GAMP 5), electronic signatures, and audit trails, they ensure safety in sensitive applications. In practice, they play a decisive role in the digital planning and improvement of workflows through role-based usage.
