Hardware change control

The RP must ensure that a hardware change control procedure, involving formal approvals and testing, is followed before hardware changes are implemented. 

Use established Change Control procedure to accommodate any new software/firmware or non-routine hardware changes ( 0)... 

The change control SOP warrants particular attention. This procedure should clearly spell out how any deviations in instrument operation/per-formance, and hardware/firmware/software updates are to be handled and documented. It should also make clear what distinguishes routine maintenance, minor vs. major changes and what the procedural differences should be. The change control procedure may be a specific SOP, as part of an HPLC system s validation plan, or as part of the corporate validation master plan (VMP) that is established within each company. 

One practical example of the consequences of change control is that in the regime of system/instrument change control, hardware, software and operational aspects such as routine operation, maintenance and data integrity are locked down in fixed configurations. Any modification that has not been anticipated in the initial qualification requires testing and documentation. 

A consistent and appropriate change control procedure must he capable of tracking the system operation and application software. The controls on data are extended to the system of hardware and software that manipulates that data. Here the primary tool for control is a clear and appropriate change control procedure. 

Change Control System configuration changes hardware, firmware, and software change and its impacts. 

Develop and implement rigorous configuration management and change control procedure for all your network hardware and software. This should also include updates of system drawings if there are any changes. 

The maintenance of computer systems becomes an essential issue, particularly when a new version of the supplier-supplied standard software is updated. A change control procedure must be implemented whereby changes in the software and computer hardware may be evaluated, approved, and installed. 

The final integrated hardware/software system must achieve a full IQ to verify that the predetermined hardware and software configuration specifications are satisfied. Be sure to verify that the software version installed on the final system is the same as the one used for OQ testing on the pilot system. If not, there must be formal change control documentation in place that verifies that the validated status of the software has not been affected. There must also be some operational testing done on the final system. If the validation plan has identified the need for IQ, OQ, and PQ, it would be reasonable to perform the OQ on the pilot system and PQ on the final system. If only IQ... 

It is particularly important to put in place quality control procedures for the development of hardware and software for plant automation. Good automated manufacturing practice provides a systematic and structured approach to the development of these systems including change control and validation methods. 

Inventory of items (hardware and software) constituting computer system Configuration management including version control Change control Document control... 

There were no written standard operating procedures for, but not limited to, system validation, hardware and software change control, revalidation,... [FDA Warning Letter]... 

Suppliers of computer systems and associated services must be managed to assure that the software, hardware, and/or related services they supply are fit for purpose. Enhancements and modifications to computer systems and associated documentation must be implemented under change control and, where appropriate, configuration management. Changes affecting the validated status of a computer system must be approved before they are implemented. 

Is there more than one change control system (hardware, software, infrastructure, networks) For each of these challenge as follows ... 

This describes the fnnctionality of the chosen or developed system and how it will fnlhll the nser reqnirements. This docnment is the specihcation against which the system operability will be tested and maintained. Specihc hardware and software prodncts may be referenced. The Fnnctional Specihcation shonld not dnplicate information available in standard prepnblished snpplier docn-mentation if commercial software/hardware is being nsed, as long as it is referenced and managed under change control. 

There were no written Standard Operating Procedures for hardware and software change control and software revision control. [FDA 2001]... 

Inadequate change control over any element of the system (i.e., hardware, software, procedures, people). 

System description of hardware and change control procedures This covers how the hardware components will be maintained (equivalent to the hardware configuration log) with the procedure to be adopted when the system configuration is changed. 

Servers should be subject to configuration management and change control procedures. Configuration records should be in place for server hardware and software. 

Installation qualification Change control reports Parameter change control records Descriptions of hardware redundancy features... 

Are change control procedures in place to manage changes to network hardware, firmware and software, including impact assessment of any application affected by change ... 

Do change control procedures require testing to be conducted when hardware or software is added, removed, or... 

Is there a change control procedure to ensure that all hardware and software changes are properly documented 11.10(k)2... 

This includes computer hardware, operating software with product name and revision number, application software with product name and revision number, network devices with product name, software and firmware revision, cables, documentation such as user manuals and configuration settings. Any changes should be documented following documented change control procedures. 

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