Change Control

Change Control Management Software

Managing change is crucial in the life sciences industry. Pharmaceutical companies operating in GMP environments are required to disclose all changes. All changes must be approved by authorities before they can be implemented. Only after receiving clearance from regulatory agencies such as the US FDA and MHRA would a pharmaceutical organization make modifications to a current product.

In pharmaceutical, biotech, and life sciences firms, managing a change might be a challenge if the process is reliant on paper. In a cGMP-regulated setting. The surveillance of regulatory requirements has a significant influence on quality. As a result of human mistakes, unintended repetition, lack of traceability, and many other issues, paper-based or manual change control solutions slow down turnaround times. As a result, productivity and product safety or quality might be adversely affected.

Issues with Manual Change Control in GMP Environments

  • The completion of some change controls might take months or even years. As a result of these circumstances, Life Sciences organizations require Change Control Management software.

  • Poor Change Management can arise when Change Control processes are handled manually. This generates a high chance of non-compliance.

  • It is difficult to monitor and take account of operations when the change is at the multi-department stage.

  • With a manual approach, it’s more difficult to maintain product documentation, which includes a full record of modifications and the ability to readily obtain essential information necessary to execute the changes.

  • Employees must be trained in the unique Change Control process in environments such as the USFDA, the MHRA, and the European Union (EU). The concerned group must complete the time-consuming training manual tracking for the adjustment to be effective.

  • It is difficult to reverse temporary change restrictions on time.

  • It is necessary to manually verify the log information for the status of the existing change controls.

The AmpleLogic Change Management Software Module is intended for the GMP-driven Pharmaceutical and Biotech industries to simplify communication channels and better coordination for improved administration of every notable step of the Change Control process, beginning with change initiation, authorization, execution, and ending with change control closure. An internal user, client, or supplier may start the modification request. Change Control Automation will increase transparency throughout all departments from the beginning to the end of the Change Control life cycle.

In a typical Change Control Software workflow, the following steps are taken:

  • Before evaluating any change, it is launched and approved.

  • The change is evaluated through assessment activities.

  • Before closing, the proposed modification would be implemented and the implementation should be verified.

  • Monitoring of change controls and implementation processes.

The AmpleLogic LOW CODE PLATFORM is used to build the Change Control Software. The visual design method aids in the automation of manual and paper-based operations to improve precision and quality while lowering expenditures.

Features of GMP Change Control System

  • Change control on a consolidated information system with automatic email notifications, work assignments, and escalation of pending tasks to the internal team and suppliers is managed by this unified system, which connects the necessary departments

  • With computerized records and audit trails, a clear step-by-step change process that covers the inception of the change proposal, review of the change, execution, and validation of the change, coupled with the conclusion, enhances transparency

  • Initiation information such as change type, change control number, initiator, department, required change location, and change suggestion, as well as reason, will be automatically gathered by the Change Control Management. It also allows adding a picture or a PDF document as evidence.

  • Users can choose review points to examine and verify the modification once it has been executed.

  • The GMP Change Control Software allows you to automatically communicate how change is classified  primarily or ultimately to a client, customer, or cross-functional team.

  • You can initiate, monitor and track all phases of a change process from inception to finish. Also, you are allowed to submit several change requests under a single change control number. Following or parallel implementation might also be used to speed up execution based on the dependence.

  • Integrating with a learning management system is easy simple on the software. There will be new change controls available for training tasks if there is a modification to the document.

  • Its automation of various procedures in Change Control reduces the expenses of change management. Ensuring that processes are standardized throughout the organization reduces cycle time and operating expenses associated with change control.

  • Other eQMS modules, such as CAPA, Learning Management System, and DMS Software, can be linked with AmpleLogic Change Control software.

  • Provides Dashboard, data for analytics, monthly or yearly reporting on change control, and categorization of change controls for each type of process.

Advantages of Change Control Automation in the Pharmaceutical and Biotech Industries

Using AmpleLogic’s Change Management System, organizations may implement the program within 3 hours of training due to its user-friendly, workflow-driven Change Control System Modules. It generates tasks automatically and provides prompt notifications and escalations. The software is easily customizable and quickly adjusts to the needs of the organization.

  • This web-based application has a very secure and unified database as well as end-user access available 24 hours a day, and seven days a week.
  • Less human errors, improved process management, and effective corporate communication with no human reliance.
  • With the aid of system-generated alerts and prompts, we ensured timely confirmations and closures, as well as appropriate escalation management.
  • Change control requests are initiated online, followed by authorization, evaluations, and verification of the change control. Validation methods include electronic signatures and activity stamps. It also contains an addition to the current change.
  • Through the electronic records, users may readily retrieve information about a change control request. Individual filters can be applied to the data.
  • This Change Control Management Solution records all actions in the change control workflow to ensure users have access to the extensive information about the process, and also administrative operations.
  • Through the use of the built-in emailing feature, you may easily communicate with customers and regulatory authorities including FDA, MHRA, and EU Annex 11.
  • It checks the unit or department’s efficiency in handling change control operations using quality metrics reporting and traceability trends. In addition, it provides a visual representation of information such as pending and finished tasks, as well as the employees participating or accountable for the tasks and the time limits allotted for such activities.
  • Complaint and Customization processes tailored to the customer’s process and implemented on the go in accordance with 21 CFR Part 11 and EU Annex 11.  Modifications can also be made to the current process.
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Other industries where Product or Process Change Management Software might be beneficial are

  • Biologics
  • Medical Devices
  • Chemical
  • Contract Manufacturing
  • General Manufacturing
  • Food & Beverages
Change Control Management - Change Control Software
Change Control Management Software

Please contact for further information on the AmpleLogic Change Control Management System and the numerous benefits it may provide your organization.