According to the high rate of production in pharmaceutics and many legal requirements in this industry based on manufacturing processes and tests and the necessity of recording all the details in the documents, a great amount of documents will be definitely created during the manufacturing processes of the products. GXP requirements and laws require pharmaceutics companies to keep the created documents in long term and maintaining this amount of papers is a costly process and retrieval of the information is very difficult. Advancement of technology and the increase of devices and systems equipped with smart software and using such systems in pharmaceutics industry for the processes of manufacturing, raw material tests and products will create a condition that can reduce the costs and facilitate controlling and maintaining production documents on one hand, and on the other hand, will allow the processes to be controlled and systems to be equipped by legal requirements. Software of comprehensive system of quality control management not only has created such space, but also it has the possibility of expanding the condition and providing newer facilities in this field. Software of comprehensive system of quality control management is the first specialized software in the field of establishing quality and implementing GXP requirements in pharmaceutics industry. The comprehensive system of quality control management is in fact an idea for complete documentation of the batches of the manufactured product not by paper but by electronic files. Therefore, using it is a great step in protecting the environment and preventing from great paper consumption. This software not only is responsible for providing, controlling and maintaining documents related to the quality of products (EBRS), but also has advanced in the field of completing documents and has done plannings, storages, processes of quality guarantee and quality control  and maintains them. It can also be equipped by hardware systems (controlling and monitoring system and manufacturing devices system) made by Kimia System Company and control manufacturing processes as well. Using these devices, manufacturing control processes, production statistics and the permission to access of operator to the device will be controlled.

 

The comprehensive system of quality control management is formed of the following 6 main parts that connects different sections of a pharmaceutics, food, and cosmetic company to each other.

  1. Production Field (Electronic Batch Records (EBRS), analytical statistics of production)
  2. Laboratory Field (raw material test, product test, daily test, stability test, analytical statistics of tests)
  3. Quality Guarantee Field (change request, complains, documents, self-inspection, post marketing quality control, recall, analytical statistics of quality guarantee, dynamic reporter)
  4. Planning Field (purchasing materials and goods, storage, production planning)
  5. Technical and Engineering Field (Repair and maintenance (PM), repair and maintenance (EM), calibration)
  6. Commercial (Product Selection Committee)

Some properties of this software are as follows:

  1. Possibility of defining users and determining the level of access that users can have accompanying authentication of users’ accessibility
  2. Possibility of recording basic information and authenticating them.
  3. Recording all the operations that each user does at the time of process from the beginning to the end in the system.
  4. Controlling, inspecting and tracing the processes related to production and product quality.
  5. Possibility of showing each stage of production process on the screen.
  6. Saving information and documents of each batch and process in the database for an unlimited time.
  7. Monitoring and automatic controlling of central systems (air conditioners, humidifiers, etc.), sensitive conditions of production and production unit devices (blistering, filling, pressing, etc.) 
  8. Providing analytical statistics (environmental conditions, products, tests, etc.)
  9. Dynamic reporting
  10. Possibility of determining standard for manufacturing process and devices.
  11. Online electronic recording of all production stages
  12. Investigation of the manufacturing procedure of products in different periods (qualitatively and quantitatively)
  13. Momentary controlling of production lines and the possibility of remote controlling via wireless network
  14. Possibility of tracing the produced batches
  15. Recording operation and stop times of manufacturing devices by the device and automatically.
  16. Automatic recording of information such as temperature, humidity, pressure via sensors and controlling the operation of air conditioners and dehumidifiers to automatically control temperature and humidity.
  17. Maintaining production time between different stages of related batches by the system and automatically.
  18. Possibility of notifying the officials.
  19. Automating calculations (calculating the weight of the batches, each product and the size of the batches, etc.)

 

Advantages of using the software of comprehensive system of quality control management:

  1. Online batch record collecting
  2. Efficiency and reduction in costs
  3. Simple reporting and data analysis and providing analytical statistics
  4. Possibility of momentary and online monitoring and controlling of the processes
  5. Quick accessibility to information
  6. Increase in the accuracy of production
  7. Creating less paper processes
  8. Simplifying the processes and reduction of complexities in production to increase efficiency
  9. Total management of production cycle
  10. Increasing information security
  11. Integrated controlling of quality and safety of products
  12. Accelerating information distribution
  13. Integrating information
  14. Remote controlling

 

 

Our Company

The well-known chemia system Company began its activity in the form of primary studies using computer specialists and consultants of pharmaceutical industry since 1386 and designed the comprehensive system of qualitative control and officially started its activity in 1390.

Apart from offering comprehensive system of quality control (the first specialized software in the field of establishing quality and conducting GXP requirements in pharmaceutical industry), the company managed to offer monitoring systems and smart controlling (for monitoring and controlling temperature, humidity and pressure) and the system of controlling production devices (for controlling the condition of production devices) proportionate with the requirements of pharmaceutical companies.