System owner

Most older SCADA systems (most systems in use) have no security features whatsoever. SCADA system owners must insist that their system vendor implement security features in the form of product patches or upgrades. Some newer SCADA devices are shipped with basic security features, but these are usually disabled to ensure ease of installation. 

F00009 Lead and Copper Rule Minor Revisions Fact Sheet for Public Water Systems That Serve More Than 50,000 Persons 816F00010 Lead and Copper Rule Minor Revisions Fact Sheet for Large System Owners and Operators [Draft]... 

Define the technology transfer team. Who is the system owner Who will operate and maintain the PA system Who are the reachback technical experts post commissioning ... 

The version of firmware may be inadvertently updated by the service engineer during service or routine maintenance without making the changes known to the system owners. The change may not have any impact on the operation of the instrument and may not be detected. However, the new firmware version is different from... 

If competition was to be introduced in a natural monopoly, the transportation system owner may create technical or economic barriers to entry for potential competitors. If a competitor attempts to enter the existing market by constructing a new pipeline, the incumbent transportation system owner will have the option of increasing the throughput and reducing the tariff until it eliminates potential willingness to construct a new competing pipeline, provided there is excess capacity in the system. 

The purpose of validation is to demonstrate the capability of the water treatment and air handling system to continuously supply the required quantity of water and air with the specified quality attributes. Documented means to provide documented evidence. Validation provides the system owner with the means of assessing when a water treatment and/or air handling system is operating outside established control parameter limits and provides a means for bringing the system back into a state of control. It results in written operating and maintenance procedures for personnel to follow, which in turn helps ensure consistent system performance. 

Following a successful periodic review, acceptance of the evaluation should be clearly stated in the periodic review report and approved by the system owner and signed by designated members of the validation team. 

The CSV Team includes persons in the organization who plan and execute the CSV activities, including the System Owner, System Users, Validation Coordinator, and specialists in various fields related to computer systems validation. The CSV Team is responsible for ... 

During this period the computer system high-level functionality is agreed upon with the users, system owner, developers, and quality for the operation and automation of the operation. Part 11 considerations are a key element in this phase, which includes the following activities. 

When multiple departments are involved in a project, the system owner will take responsibility for the validation documentation. Other departments will provide documentation and personnel to support the development, validation, and maintenance effort. 

Validation plans must be reviewed and approved by the author, the organization owning the execution of the plan, and by the system owner, because they will take the responsibility for the plan. 

The persons responsible for managing the change process evaluate the feasibility and impact of the proposed change in relation to their area of expertise and authority Areas that should be included in the evaluation process are, as applicable QA, regulatory compliance, area management, the system owner/sponsor, the end-user, and technology professionals (e.g., IT, engineering). 

The system owner, system administrator, system user, and system support personnel must participate in regular periodic reviews of the validated system. Upon completion of the periodic review, the findings must be documented and an action plan developed to correct any gaps found during the assessment. 

System owner The person(s) who have responsibility for the operational system, and bear the ultimate responsibility for ensuring a positive outcome of any regulatory inspection or quality audit of the system. 

The system life cycle starts with the conceptualization period. This period is critical and is the highest level of design, and is primarily the responsibility of the system owner. The purpose of the conceptualization period is to establish an integrated model of the operation to be automated or re-engineered. This model provides the criterion to company senior management, enabling them to make a business and/or regulatory decision on whether to continue with a project. 

The scope of the system generates many of the support requirements for the operations, usually provided by the system owner. The term requirement defines a bounded characterization of the scope of the system, and contains information essential to support the operation/operators. Some of these requirements include functional capacity, execution capability, operational usability, information needed to support validation, installation, commissioning, SLC documentation required, user s manuals, training, maintenance manual, system maintenance, system test plan, acceptance criteria, and regulatory compliance (e.g., Part 11). 

Risk is defined as the probability of an undesirable event occurring and the impact of that event if it does occur. The result of this analysis will influence the degree to which the system development, implementation, and maintenance activities are performed and documented. By evaluating the system risk analysis, the system owner may uncover potential problems, which can be avoided during the development process. The chances of a successful, if not perfect, system implementation are improved. 

During the software IQ the developer will produce a plan for installing the software in the target environment as specified by the technical requirements specification deliverable. The resources and information necessaiy to install the software product must be determined and be made available. The developer must assist the system owner and maintenance personnel with the setup activities where the installed software product is replacing an existing system, the developer must support any parallel operation activities required by the contract. The installation plan and procedures must be documented. 

Simply monitoring quality performance is just not adequate. The effectiveness of quality management systems should be actively managed and performance improvement opportunities seized. Business benefits should more than compensate for any investment in quality. Senior management, system owners, project managers, and anyone else involved with computer projects need to appreciate this. This book will help explain what needs to be done to successfully achieve quality and compliance of computer systems in the pharmaceutical and healthcare industries. 

System Owner/User Responsible for defining system requirements, ensuring that validation is conducted in a compliant manner, that appropriate user procedures are in place, that users are trained, and that validation is maintained once the system is in use, right on through to decommissioning. 

Most pharmaceutical and healthcare companies will split the roles mentioned above into several specific jobs as appropriate to their organizational structures. For instance, the Quality and Compliance role may be split into an Operations Quality Representative and a Validation Expert. Equally, the Developer role may consist of Project Manager, Project Engineers, and Supplier Representative. Similarly, System Owners may sometimes delegate responsibilities such as specific maintenance activities to a system administrator function that may be internal or external to the company. The Quality and Compliance role, however, must not be combined with other roles otherwise its independence will be compromised. 

System Owners/Users are accountable for assuring that computer systems used by them, or on their behalf by other organizations, in support of pharmaceutical regulatory requirements and pharmaceutical regulated areas or processes are compliant with pharmaceutical agency regulations, are properly validated, and are used in a compliant manner. 

Quality and Compliance are responsible for establishing necessary pohcies and procedures to manage validation and for approving validation work. They must be able to demonstrate their independence to the System Owner/User, and to the Developer and Operational Support organizations. 

A system owner should be (should have been) appointed for every system. This should be laid down in the system documentation (or validation plan). A proposal for a change should be directed first to the system owner, who shall be responsible for ensuring that all changes to the system are reviewed, authorized, documented, tested (if applicable), approved, and implemented in a controlled manner. The system owner may delegate this responsibility if permitted to do so in the validation documentation. 

Unique reference number, to be assigned by the system owner or his delegate using a logging mechanism... 

After implementation of the change (in the operation environment) the system owner should formally accept the change. This formal approval can be made based upon the test results, or the system owner might decide to perform some separate acceptance test. 

The diagram for the life cycle presented in Figure 5.1 is complemented in Figure 5.4 with one showing the main roles of System Owner/User, Developer, and Quality and Compliance defined in Chapter 3. Each role is described below. 

The System Owner/User role is responsible for defining and approving requirements. It should be possible to describe in overview the system to be implemented from this information. The System Owner/User should then agree with Quality and Compliance what functionality within the computer system is GxP critical. This is used to help select the supplier to develop the system. The System Owner/User should lead a Design Review to verify that what is being developed meets the requirements, with feedback to the design and development group(s) as required. The User Qualification Process should take account of GxP Assessment of critical functions, the capability... 

The Validation Plan must be reviewed and approved before issue. They are regulatory documents specifying the quality and compliance controls nsed to manage the deployment of a compnter system. At a minimum, a Validation Plan shonld be signed and dated by the System Owner as well as by the Quality and Compliance representative. 

Compile a list of systems, assign system owners, and identify those that need to be brought into compliance. Communicate the objective, including the support of management, to everyone involved. 

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