In FDA-regulated and ISO-certified environments, companies are expected to establish procedures for a change control system in order to ensure product quality and safety. Regulated and ISO companies are also expected to maintain detailed documentation on all changes that are made.
Given the multitude of ongoing processes for document change(design specs, formulations, SOPs, specifications for raw materials, etc.), a change control system that is automated is indispensable.
Best practice form
The change control system from MasterControl offers a pre-configured, multi-page best-practice form for collecting and tracking data throughout the entire change control process.
- A section in the change form captures information such as: description of change, justification, and impact. Both original and revised documents can be attached for easy comparison.
- The initiator of the change can use the same form for multiple changes. For example, the form for a change in a component used in making 10 products can have 10 attachments, greatly streamlining the process.
- The change control system prompts the initiator to evaluate the change in terms of training requirements, validation, and regulatory requirements prompting risk assessment.
- The initiator is also asked to classify the change as low, medium, and high. Any high-level change implies great impact on the product and is likely to require regulatory filing.
- In addition, the change control system prompts the initiator to categorize the change as routine, temporary or emergency. (A high-level change usually implies great impact on the product and is likely to require regulatory filing.)
- The form for change management can be customized to meet any unique requirements.
Additional features
Other important features provided by the change control system from MasterControl are outlined below.
Form-to-Form Launching – A change submission form can be launched directly from a Corrective/Preventive Action (CAPA) form, connecting one process to the next. MasterControl streamlines this process and maintains the links, making it easy to see what triggered the change. Relevant information from the CAPA form will be automatically entered into the change submission form, reducing data entry. It also shows the history of the entire process.
Document Approval via Forms – With the change control system from MasterControl, the change submission form and the documents linked to it can be approved all at once, avoiding repetitive steps.
Dependent Routing – Completion of a task can be made dependent on another task to give managers more control and reduce cycle time (by prompting users immediately to begin their next task). An innovative dependency tree graphically illustrates the relationships between dependent processes.
Dynamic Organizers – The MasterControl Organizer, similar to Windows Explorer, is an easy-to-use and dynamic tool for finding and retrieving documents. All SOPs and other documents related to a particular change can be grouped together. Users can create virtual folders within Organizers that will automatically retrieve documents based on pre-defined queries.
Powerful Reporting Tool – The change control system can group data together by time interval, then chart the data for a specified range of dates. For example, the number of customer complaints that have led to a change can be totaled for each week and charted for the last year. Data can be summarized at multiple levels, so that change orders can be reported on by product, department, root cause, etc.
For More Information
For more information about change management software, or the change control system from MasterControl, please feel free to contact a MasterControl representative.
