Closed Loop Change Management
As the saying goes, ‘without change, progress doesn't exist’, a drive for continuous improvement is the common denominator that initiates the need for a change. Inevitably, an organization will need to change a process, system or product, at some point in its lifecycle, in order to keep up with growing market demand and to keep pace with the competition.
While the reasons driving a need for change may vary - whether to offer the process improvement, product upgrade or to correct a defect - the process leading up to the change request process is always complicated and needs to be managed properly in order to result in an effective outcome and to meet the compliance requirements. The process of Change Management is often complex - involving several cross functional users, systems and/or processes and/or equipment and/or instruments and/or computer systems, various departments, suppliers and more. The Change Management process involves various levels of planning and sourcing, and collaborating with not only internal sources, but external sources as well. The bottom line is, increasing speed and complexity within the change management process demands more effective process management.
The ValGenesis system provides a closed loop change management process; the process begins with the initiation of the Change request, which may be from an internal member of the company. In ValGenesis, change control and validation are intertwined, in order to achieve a completely closed loop quality management process. The change control process within ValGenesis follows GAMP 5.0 guidelines, while providing users with the flexibility to configure the change management process to meet their existing business processes. ValGenesis electronically manages change requests and relates the impact of the changes to document deliverables that are generated in the system. Through the system, users are not only able to track changes but they are also able to see the document deliverables required as result of the change. Required documents are authored and executed within ValGenesis. At the time of final closure of the changes, all the impacted validation documents will be available for approvers to finally close the change control process.
Key Capabilities
Follows GAMP 5.0 Guidelines
The Change Control module in ValGenesis was designed with GAMP 5.0 in mind. This being said, the system still offers a high degree of flexibility in terms of allowing users to define one-to-many change control processes that more closely match their existing change control procedures. Through the ability to create multiple change control processes, ValGenesis can manage any type of change efficiently. Furthermore, change exceptions such as Like-for-like, Emergency etc. can be applied to change requests to further accelerate the change control process when warranted.
Highly Configurable and Flexible Process Maps
ValGenesis Change control module offers users the ability to configure any number of process maps. Process maps within the system determine how a change control should be handled, once it has been reviewed by the change review board. A process map is a user defined controlled workflow that is utilized to route a change control before and after the change has been implemented. Building Process maps include, determining the process and which user groups should review, document deliverables, how to implement and approval of the change control.
Validation Linked to Changes
ValGenesis is unique, insofar as the system links validation documents with change controls. ValGenesis provides a completely closed loop quality process allowing users to track changes and track document deliverables associated with the change. Once the required document deliverables have been specified, the documents will be available automatically to assign for development (authoring), or execution. By linking validation/controlled documents to changes, the system provides users a simplified mechanism to see how changes influence validation/controlled documents and track document progression.
Process Control
ValGenesis provides a high degree of control over the change management process. The system maintains a comprehensive audit trail for each change in the system, allowing users involved with the change to see the complete genealogy for the change control. It is through this transparency that system owners, change review board members, and any user involved with the change are able to attain better control on the process. Delays in the change control can be easily identified and rectified, therefore, the entire change management process can be accelerated.Features and Benefits
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Feature |
Benefit |
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Follows GAMP 5.0 Guidelines |
ValGenesis has been designed to follow GAMP 5.0 guidelines Changes are routed through a controlled workflow to ensure data integrity |
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Highly Configurable |
Process maps enable users to design any number of controlled process flows in the system to mirror existing change control process ValGenesis does not impose any restrictions on how changes should be managed |
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Validation documents Linked to Changes |
System automatically links changes to validation/controlled documents to achieve a 100% closed loop change management process Impacted validation/controlled documents related to changes can be easily tracked in the system |
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Process Control |
ValGenesis provides audit trails that capture each action taken allowing a high degree of transparency to the process Bottlenecks and delays in the process can be easily identified and quickly resolved to accelerate the change management process |
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Summary View |
ValGenesis provides a change summary, at any given time, that describes the change to be implemented, and identifies the affected validation/controlled documents, list of functional users/stakeholders, and action plans System allows the submission of the request to the appropriate individuals for approval. If the request is approved, it then allows monitoring of all associated activities, such as implementing the planned projects and action plans, and updating the associated documentation
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Reduces the Cycle Time for Engineering Changes |
Through the controlled workflow available in ValGenesis, the system will ensure that all the required information is sent to responsible individual(s), at scheduled times and in a predetermined way. As soon as one task (in a certain phase) is finished, the document will be sent to the person responsible for the next phase. Each user should complete the task on time (i.e. should meet the specified due date). Users are alerted with the due date when a task should be completed. Reduced time will translate into cost reduction, faster cycle times and improved productivity |
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Reduces the Costs of Change Management |
With the ValGenesis change management module, the client is able to assign a team of users to be responsible for all phases of a change process, including Change review board (CRB), stakeholders or cross-functional users, reviewers, approvers and system owners. The team is then able to follow up and collaborate easily because the change management system is automated. Hence, controlling the process is enhanced, bringing time savings and reducing overhead costs.An efficient change management process enhances customer satisfaction, production efficiency, and lowers production costs
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Tracks the Change Process in real time with metrics |
The Change Management process available in ValGenesis controls the flow of the change request process. It can easily provide information as to the tasks carried out on the project. This information could include, but not be limited to, the name of the person who carried out the task, when they started working on it, who they received it from, when they stopped working on it, etc. If there is any bottleneck in the process, the system will be able to trace back to see what happened |
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Manage and monitor the changes
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Change Management provides real time status reports. Changes will be easier to manage using the information available. The decision-makers will know which change processes have been completed, how many process are still pending and who is responsible for each one, etc. This will provide faster and more reliable reports than any manual reporting. In addition, the system provides information about past changes |
