– Security: Computer system should be accessed by authorized person only.
Extent of security shall depend on criticality of computerized system.
This will include definition of all settings and parameters.
4.7.4 Hardware design shall define hardware components i.e. 4.7.5 Network design specification shall include network diagram, security consideration and performance requirement.
Suitable method like passwords, keys, biometrics, restricted access to the area should be in place.
– Electronic signature: Electronic signature should be secure and should represent the person who processed the data.
The following code example uses the derived class Text Box and validates an e-mail address that the user enters.
If the e-mail address is not in the standard format (containing "@" and "."), the validation fails, an Error Provider icon is displayed, and the event is canceled.
Additional checks can be included wherever applicable.4.8.2 Based on complexity of the system, protocols can be prepared for specific component/function separately. 4.8.5 Separate protocols or combined protocol can be prepared for IQ, OQ and PQ depending upon type of computer system, usage and its complexity. 4.8.7 Qualification/validation protocol shall contain following non-exhaustive content- – Objective – Scope – Roles and responsibilities – Tools required – Procedure – Acceptance criteria – Test data sheet – Reference 4.8.8 Computer system validation shall be executed as per pre-approved protocols.4.8.3 Each protocol shall identify following: – The specific task to be completed. Any change from the approved protocol shall be agreed by all concern department and deviation shall be logged if required.4.1 This procedure shall include validation of below computer system/software: Manufacturing automation computer system/software: PLCs (Programmable logical controllers), MMI (Man Machine Interphase), BMS (Building Management System) etc.Production monitoring computer system/software: Material management software, Material requisition and issuance software, work order management software, stock management software.