The main purpose of production managers in production sectors of pharmaceutical, food and cosmetics industries is gaining required controls to produce high quality products. One strategy to reach this purpose is data collection in the process of production to study and investigate factors influencing production. The field includes electronic batch records (including production processes such as solids, semi-solids, liquids, sterile, vaccines, and cephalosporins) and analytical statistics of production.

Electronic Batch Records (Pharma EBRS):

Batch record electronic is the main subsystem of Pharma Engine software that is responsible for creating, recording, confirming, maintaining and controlling documents related to the produced batches in pharmaceutical factories. In fact, batch record electronic provides a showcase for company’s knowledge as the capital interest and the batch record indicates assurance about recognizing the quality of the product. Having the batch record electronic at the time of investigating or auditing allows the company to show how important following rules and producing high quality products are for it. Also in crisis, having information about batch record electronic will allow rapid access to information at the time of production and taking accurate and required measures. The forms and instructions of production and controlling producing and weighing processes, product formulation and confirmation of documents and product output from the factory will be created and circulated in this subsystem. Circulation of these documents will be based on procedures and individuals’ access to different information will be according to the level of accessibility that has been defined and confirmed and each operator can monitor systems and observe documents according to the determined duties.

Ultimately, provided documents will be archived based on the name, code and number of product batches and at this point the software is not allowed to edit any information. Seeing the information will be available for limited individuals and based on the determined accessibility.

Electronic batch record facilities (EBRS):

1. Possibility of defining users and determining the level of accessibility besides authenticating users’ accessibility.
2. The system of authenticating basic information.
3. Possibility of defining the stages of production process.
4. Defining product specifications (checklists, tests and formulas, product tree).
5. Production stage: recording information related to the producing batch from the beginning till the end (Customs clearance and delivery of final products to sales warehouse)
6. Possibility of showing each stage of production on the screen.
7. Saving information and documents of each batch and process in the database for an unlimited time.
8. Recording all the operations that each user does in the system at the time and date of starting the process, from the beginning to the end.
9. Investigating the procedure of produced products in different periods of time (qualitatively and quantitatively).
10. Traceability of the produced batches.
11. Automation of calculations (calculating the weight of batches, calculating any number of products, calculating the size of batches).
12. Maintaining production time between different stages of the related batches by the system and automatically.
13. Tracing the sources used in the produced batches.
14. Voice messaging systems.
15. Text messaging systems.

The advantages of using electronic batch recorder (Pharma EBRS):

1. Reduction of errors on paper files
2. Facilitation of production process with the reduction of time required to edit a simple file (facilitating case investigation)
3. Improvement of quality and safety of ventilation operations
4. Focus of operators activities on value-added measures (production or ventilation)
5. Facilitation of document and data collection while production
6. Facilitation of product investigation and product registration
7. Reduction of time required to rule the order of registration of a batch of the product
8. Increase of quality control related to managing the registration of a product batch.