Our services

VALIDATION OF COMPUTERIZED SYSTEMS
VALIDATION OF COMPUTERIZED SYSTEMS
  • Software validation
    We confirm that the software specification corresponds to the user’s requirements and the intended use. Software that requires validation is used to support regulated processes. It replaces manual actions.
  • Integrity data
    We provide database protection, thanks to which we can be sure that the data will not be modified, falsified or deleted. This is particularly important in the pharmaceutical industry when it comes to drug safety.
  • Serialization
    We protect against dispensing falsified medicinal products. Serialization provides security in the form of unique identifiers as well as devices that counteract data manipulation.
  • Software quality management
    We implement, test and maintain the computer system. We provide Software Quality Assurance, which focuses on the life cycle of a computer system.
  • Software validation in laboratories
    We take responsibility for validation activities in laboratories. We assess systemic risk, create validation reports, and help in the process of maintaining a validated system.
  • Software validation in laboratories
    We take responsibility for validation activities in laboratories. We assess systemic risk, create validation reports, and help in the process of maintaining a validated system


QUALIFICATION - TECHNICAL VALIDATION
QUALIFICATION - TECHNICAL VALIDATION

  • Qualification of installations and process utilities
    We make sure that water and compressed air installations, as well as equipment and support systems, can work stably and continuously. Their efficient operation affects the production equipment. Installation qualification applies to air conditioning, ventilation, purified water, injection water, compressed gas and steam installations.
  • Qualification of laboratory installations
    We make sure that water and compressed air installations, as well as equipment and support systems, can work stably and continuously. Their efficient operation affects the laboratory equipment and the results of laboratory analyzes. Installation qualification applies to air conditioning, ventilation, purified water, injection water, compressed gas and steam installations.
  • Qualification of production equipment
    We check whether the production equipment and support systems are operational. We qualify entire production lines, packaging and production equipment as well as auxiliary equipment.
  • Qualification of laboratory equipment
    We check whether the laboratory equipment and supporting systems are operational. We qualify incubators, sterilizers, laminar flow ventilation, stability chambers, HPLC.
  • Qualification of premises
    We check whether the premises are compliant with GMP requirements and HVAC recommendations before they are put into use. We perform environmental tests – we check humidity, temperature, airflow, etc. The premises qualification applies to production and laboratory rooms in zones A, B, C and D based on ISO14644-1, special rooms, storage rooms, and passenger and goods locks.
  • Validation of the production process
    Before a process is approved for serial production, it must be verified that it produces a good-quality product. As a result of the validation of the production process, we will receive documented evidence.
  • Validation of the washing process
    We check that the cleaning activity of the equipment thoroughly removes all pharmaceutical ingredients of manufactured products, cleaning agents and microorganisms. Thanks to this, we can be sure that the next manufactured product will not be contaminated by active waste from the previous product. Works are performed according to GMP rules. The validation of the washing process applies to rooms, washing production and auxiliary equipment, automated CIP processes and manual methods. The validation of the washing process also involves the development of a washing management strategy.
  • Validation of analytical methods
    We evaluate and document the characteristics of the analytical method, e.g. accuracy, repeatability, reproducibility, precision, linearity, stability, range, detection limit and quantitative limit. The result of this work is documented evidence that validation is appropriate for the purpose. The validation of analytical methods applies to chromatographic, spectroscopic and electrochemical methods.
  • Validation of medical devices
    The effect of validation of medical devices is documented evidence that medical devices are of high quality, and the production process is stable and there is no uncontrolled downtime.
  • Maintaining a validated state
    After the validation is completed, remember to maintain the validated state. This is the stage of transition to operation and maintenance. It involves managing incidents and changes, and making systematic reviews.


SECURE IT PROCESSES
SECURE IT PROCESSES

Modeling and quality management of IT processes

  • Comprehensive quality management in matrix and integrated IT (TQM)
  • Just-in-time delivery (JIT) services
  • Increasing the speed of service and delivery
  • Simplifying IT organization processes (e.g. Lean concept)
  • Building an IT oriented to internal and external clients
  • Operation cost management
  • IT management decentralization
  • Process redefinition (reengineering)
  • IT project/program management


QUALITY MANAGEMENT OF DATA PROCESSING IN MEDICINE
QUALITY MANAGEMENT OF DATA PROCESSING IN MEDICINE

  • Operational analytics and optimization
  • Data mining and data integration
  • BI solutions and data warehouses
  • Historical data migration


SOFTWARE DEVELOPMENT IN MEDICAL INDUSTRY
SOFTWARE DEVELOPMENT IN MEDICAL INDUSTRY

We model IT processes and manage the quality of processed data in medicine. We also care about software development in medical industry. We perform all tasks based on ISO 9001 standards and according to the TQM (Total Quality Management) concept. We also implement methods such as:

  • KAIZEN
  • 5S
  • FMEA (Failure Mode and Effects Analysis)
  • QFD (Quality Function Deployment)
  • SixSigma
  • JIT (Just in time)
  • Kanban

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