Installation of computerized systems is now an essential part of any manufacturing organizations. Manual operations are not easy in this fast moving and rapidly changing world. Since manual operations are subjected to various limitations and disadvantages like accuracy, time, etc, therefore computerized systems should replace manual operations to obtain product’s quality control and quality assurance.A computerized system should fulfil the basic requirements as discussed below:
Computerized systems are prefaced and introduced in accordance with manufacturing systems like from storage, quality control and distribution of the product. This is easy to understand the theory related to computerized systems in the introduction other than any other place in the guide. When a manual operation is being replaced by the complete computerized systems, it is necessary that there should be no changes observed in the quality assurance and quality of the product. But some of the basic considerations should always be kept in mind when shifting to total computerized systems from manual operations. There would be some trailing aspects which can arise due to the negligible use of operators.
It is very important that there should be contiguous co-operation between the main staff and other staff engaged in computerized systems. Individuals covering the responsible areas of systems should have enough training so that they can manage and use their field systems with more responsibility. Personnel should be expertise of their fields so that they can give advice and suggestions on different aspects like design, installation, validation and operation of computerized organizations.
The degree of validation depends on various factors that include the use of computerized systems that is going to be installed in the area, this will declare that if the validation is for only display or it will fulfill the future needs and also whether it has the incorporation of original elements or not. Validation is very important when you are setting a complete computerized system. Computer system has a complete life cycle which includes different stages from planning to modification and in between these, specification, testing, commissioning, programming, monitoring and documentations are included.
The system should fulfill the following requirements and should cover every area with great expertise and capability.
1. Setting A Suitable Environment:
Suitable environment and necessary requirements should be fulfilled in order to set the equipments in the area so that the external factor does not affect the system.
2. Explanation Of Usage Of System With Detailed Information:
The system must carry detailed information with diagrams and should be updated frequently. It should describe the principles, procedure, objectives, precautions and extent of system. It should also explain the usage of computer systems and interactions with other systems and its procedures.
3. Software Requirement For Product Quality Assurance:
Software is the essential part of any computerized system. The user should know the reasonable and appropriate knowledge about the production of such software that should fulfill the need of quality assurance of products.
4. Complete Monitoring Of Data Processing:
The computerized systems should monitor the data processing and built-in checks for right entry.
5. Testing And Validation Of Computerized Systems:
When a computerized system is installed in any area, the users should test the system and ensure that if the computer is providing desired results or not. When manual systems are being replaced by computerized systems, make sure that proper two systems should be working for testing and validation purposes.
6. Require Authorized Individual For Confidential Data Processing Work:
An authorized person should be appointed for data entry work. Unauthorized methods of entering data are prevented through the use of pass cards, restriction for computer usage, use of keys and personal codes. A proper and defined procedure should be provided and facilitated to the authorized person for amending the data such as changing the personal keys. Installation of proper security recorders is important to stop or fight against the unauthorized attempt made by other individuals.
7. Rechecking Of Critical Data:
Proofreading or re checking of critical data should be done like the data that are entered manually such as batch numbers or weights of the products during dispensing. Accuracy of the products record is important and therefore should be rechecked. This can be rechecked by some other operator of any electronic means.
8. Record Identity Of Authorized Person:
As there is some restrictions on the individuals for data entering, therefore proper record of the identity of the nominated persons should be kept to ensure the authorized amendment of data. If there is any change made to authorize data, it should also be recorded properly.
9. Complete Accuracy Of Critical Data:
When critical data are being entered manually (for example the weight and batch number of an ingredient during dispensing), there should be an additional check on the accuracy of the record which is made. This check may be done by a second operator or by validated electronic means. Complete and proper record of all the data entry should be maintained into the system.
10. Alterations In The Computerized Systems:
A definite procedure should be followed to make different alterations in the computerized systems according to recent update. This may include validation, checking, approving the change and lastly implementing it. These alterations should be made according to the agreement of the individual who is responsible for that area of system and these alterations should be verified.
11. Printed Copies Of Quality Checked Products:
To examine and check the quality, clear printed copies processed by electronically stored data should be provided.
12. Alteration Does Not Affect Performance Of Systems:
Recording the data will prevent it to from any accidental damage or lost. The data stored in the system should be accurate, durable and accessible. When an alteration is made to the system, the system should be tested for the previously mentioned factors so that the alteration does not affect the function and performance of the system.
13. Making Back-Ups Of Critical Data:
Frequent storage and making back-ups of the data is important for its protection. The data should be stored at proper, secure and separate location.
14. Implementing Alternative Procedures On Accidental Breakdown:
If any breakdown or accident happens with the system, the back-up or alternative installed systems should be available to work. Urgent need of the alternatives systems is required in less time period to fulfill the need.
15. Tracking Of Validated Process:
The defined and validated procedures should be followed with the alternative system in case of any break down occurs with the working systems. Remedial action should also be recorded for any failures.
16. Analyzing The Possible Errors:
A recorder or analyzer should also be installed with the system which can keep the checks on the possible errors occurring during the process and immediate corrective actions should be taken in response to any errors.
17. Requirement Of Proper Agreement:
A formal agreement should be made with the outside agencies if the services are taken from them so that you can claim the errors of the system to them and they are responsible to check these errors.
18. Dispensing of products:
A qualified person is provided with the authority to dispense and release the supply using a computer system.
To summarize the requirements and essentials of the computerized systems, it can be seen that replacement of manual operations with computerized system is not an easy thing. It may require the fulfillment of principles, validations, authorized personnel, and other system requirements. system requirements may include complete data processing, monitoring of data, alternations if required, use of alternatives in case of any breakdown, validation, analyzing and in last dispensing and releasing the product under proper agreement.