Change Control Process

The Change Control Process ensures that every change is systematically reviewed, approved, and implemented to maintain quality, safety, and compliance. Each section of the process represents a specific stage that involves different roles and responsibilities to ensure the change is properly managed. Below is a detailed breakdown of the sections involved in the Change Control Process.

Section 1: Initial Request

The change request process starts with a user in the Initiator role, who creates a new record in the Change Control module. The Initiator completes Section 1: Change Request by providing detailed information about the proposed change, including its nature and rationale.

Navigation: Home screen > Change Control > Add.

The Initiator must also determine if the change will have any significant impact on the process or product in the section titled “Change Impact Document Review”. This includes selecting relevant documents such as:

• Standard Operating Procedures
• Batch Documentation
• Validation Reports
• Risk Assessments
• Other key specifications

Users with QA Specialist or QA Manager privileges can also update these fields.

Navigation: Home screen > Change Control > Edit. Highlighted are the fields that QA Specialists / QA Managers need to check.

Once the form is completed, the user moves the record to the "Section 1. Pending Approval Quality" step.

Note: If the "Initiating Unit" is the same as the "Receiving Unit", the system will require only one impact assessment from the department manager of this unit in Section 2. In such cases, the user must select the same unit for both fields.

Navigation: Home screen > Change Control > Edit. Highlighted is status "Section 1. Pending Approval Quality", which sends an automated notification to QA Specialists / Managers.

Updating the status automatically triggers an email notification to all users with QA Specialist and QA Manager privileges, informing them that a new change request requires their review.

The assigned QA user reviews the submitted details and, upon validation, locks the section by clicking the "Section Locked" button. Locking prevents further edits and ensures the initial request is finalized.

Navigation: Home screen > Change Control > Edit. Highlighted is the button that locks the section.

Locking the section also automatically generates Section 2, initiating the next phase of the review and approval process.

Home screen > Change Control > Edit. Highlighted is the Section 2 submodule, which is created (it can be seen by the counter of the records in submodules, which show one).

Locking Information

Users with the roles QA Specialist, QA Manager, and Quality Director have the ability to lock or unlock Section 1. These permissions are configurable and can be adjusted within the system settings.

Process Summary:

1. System Action: The Initiator creates a new Change Control record in the system.
2. User Action: The Initiator completes Section 1 by describing the proposed change and selecting relevant documents in the Change Impact Document Review section.
3. User Action: The record is transitioned to "Pending Approval Quality".
4. System Action: The system automatically notifies all users with QA Specialist and QA Manager privileges via email.
5. QA Specialist / QA Manager Action: Reviews the submitted details, locks Section 1 to finalize it, and triggers the automatic creation of Section 2.

Section 2: Change Coordination

Once Section 2 is created, the system sends email notifications to:

• The manager of the initiating department
• The manager of the receiving department (where the change will be applied)

1. Department Managers' Impact Assessments

Posting Impact Assessment Rules:

• If the initiating and receiving departments are the same, an assessment is required from only one manager.
• If the departments are different:
  • The system first requires feedback from the initiating department manager.
  • Only after this assessment is submitted can the receiving department manager provide their comments.

During this phase, additional managers from other departments can log into the system, navigate to Section 2 > Impact Assessment, and provide their assessments on the impact of the change.

2. Coordination

Once the department managers' comments are registered, the system automatically sends notifications to:

• The Author (Initiator)
• The QA Specialist
• The QA Manager

After the impact assessments are submitted, these users must:

• Add the approvers in the Section 2 > Approval Entities field.
• Move the record to the "Pending Coordination" step.

At this point, the system automatically triggers email requests to all approvers, asking them to either approve or reject the change request.

Note: Approvers receive automated daily email notifications for all unresolved requests.

• If any approver rejects the request, the system updates the record to "Rejected", and the process ends.
• If all approvers approve the request, the record is updated to "Approved", and an automatic notification is sent to the Quality Director.

3. Quality Director Evaluation

The Quality Director opens Section 2 and enters their evaluation in the field "Regulatory Notification Assessment from Quality Director".

After providing their evaluation, the Quality Director determines whether additional assessments from the Research and Development Manager or the Health and Safety Manager are required.

• If no additional assessments are needed:
  • The Quality Director transitions the record to "No Additional Feedback Needed".
  • This action locks Section 2 and generates Section 3.
• If additional assessments are required:
  • The Quality Director activates the options "Requires Assessment from Research & Development Manager" and/or "Requires Assessment from Health and Safety Manager".
  • The record is moved to "Pending Additional Feedback".

The system then sends automated email notifications to the selected roles, prompting them to log in and provide their evaluations in the newly activated fields of Section 2.

4. R&D and Health & Safety Managers' Assessments

This step applies only when the Quality Director determines that assessments from the Research and Development Manager and/or the Health and Safety Manager are required.

Once the required evaluations are submitted:

• If only one assessment is required, Section 2 locks as soon as that role completes their input.
• If both assessments are required, Section 2 locks immediately after the second role submits their evaluation.

Locking Section 2 triggers the system to generate Section 3, advancing the process to the next phase.

Note: If a role needs to edit their assessment after the section is locked, they must contact a user with permissions to unlock the section.

Locking Information

Users with the roles QA Specialist, QA Manager, and Quality Director have the ability to lock or unlock Section 2. These permissions are configurable within the system settings.

Process Summary:

1. System Action: The system generates Section 2 and notifies the managers of the initiating and receiving departments.
2. Department Managers: Provide their impact assessments:
   • If departments are the same, feedback is required from one manager.
   • If departments are different, the initiating department submits feedback first.
3. System Action: Notifications are sent to the Author (Initiator), QA Specialist, and QA Manager.
4. User Action: Approvers are added in the Approval Entities field, and the record is moved to "Pending Coordination".
5. Approver Action: Approvers approve or reject the request:
   • If rejected, the record is marked as "Rejected".
   • If approved, the record moves to "Approved".
6. System Action: The system notifies the Quality Director.
7. Quality Director Action: Evaluates Section 2 and determines whether additional assessments are required.
8. R&D and Health & Safety Action: Submit their assessments if required. Section 2 is then locked.
9. System Action: Locking Section 2 generates Section 3, advancing the process.

Section 3: Impact Assessment of the Change

Upon the automatic creation of Section 3, the system sends an email notification to users with QA Director privileges, prompting them to review the section.

1. Determining Additional Coordination

Before proceeding with the impact assessment, the QA Director must first determine whether additional coordination from specific employees (e.g., subject matter experts) is required:

• If additional coordination is not needed, the QA Director proceeds with the regular steps of completing the Impact Assessment.
• If additional coordination is needed, the QA Director transitions Section 3 to the status "New Reviewers Required".

Note: While Section 3 is in the "New Reviewers Required" status, it cannot be locked until the additional coordination is complete.

2. Handling Additional Coordination

Once Section 3 is moved to "New Reviewers Required", the system automatically updates Section 2 to the status "Pending Second Coordination Entities".

At this point, the QA Director must:

• Open Section 2.
• Enter the new approval entities (employees responsible for additional coordination).
• Move Section 2 to the status "Pending Second Coordination Review".

This triggers the system to send email notifications to the new approval entities, requesting their review.

The process for approvals/rejections in this phase is identical to the process described earlier in Section 2:

• If any reviewer rejects the request, the system updates the change control record to "Rejected", and the process ends.
• If all reviewers approve the request:
  • The system automatically locks Section 2.
  • Section 3 updates to the status "Additional Review Completed".

3. Proceeding with the Impact Assessment

Once Section 3 is in the status "Additional Review Completed", the QA Director can proceed with the regular steps:

• Log into the system, open Section 3, and complete the Impact Assessment of the Change, classifying the change based on its potential impact.
• Determine if a review by the Change Control Committee (CCC) is required and activate the corresponding option if needed.
• Lock Section 3 by clicking the "Lock Section" button.

4. Automatic Progression

• Locking Section 3 automatically generates Section 4 for the next phase of the process.
• If the CCC Review option is activated, the system also generates Section 6 for committee review.

Locking Information

• Section 3 can only be locked or unlocked by users with QA Director privileges.
• This ensures only authorized personnel can manage this critical phase of the process.

Process Summary:

1. System Action:
   • Section 3 is created, and QA Director users are notified.
2. QA Director Decision:
   • Determine if additional coordination is required.
   • If yes, move Section 3 to "New Reviewers Required".
3. System Action:
   • Section 2 is updated to "Pending Second Coordination Entities".
4. QA Director Action:
   • Enter new approval entities in Section 2.
   • Move Section 2 to "Pending Second Coordination Review".
5. System Action:
   • Notifications are sent to new approval entities for review.
6. Employee Action:
   • Approval entities review and approve/reject:
   • If rejected, the change control record is marked as "Rejected", and the process ends.
   • If approved, Section 2 is locked, and Section 3 updates to "Additional Review Completed".
7. QA Director Action:
   • Proceed with the regular Impact Assessment of the change.
8. System Action:
   • Locking Section 3 generates Section 4.
   • If CCC review is required, Section 6 is also generated.

Section 4: Change Effectiveness Assessment

Upon the automatic creation of Section 4, the system sends an email notification to users with the QA Director privilege, prompting them to complete the section. The QA Director must assess whether an Effectiveness Evaluation is required for the proposed change.

In this section, the QA Director reviews the impact of the change and determines whether it is necessary to conduct an evaluation of the change's effectiveness. The QA Director fills out the appropriate fields, deciding whether the evaluation is needed by toggling the "Effectiveness Evaluation Required" option.

If the QA Director determines that an effectiveness evaluation is necessary, the system automatically creates Section 11 for the effectiveness evaluation process. Once the fields in Section 4 are completed, the QA Director locks the section by clicking the "Lock Section" button.

Upon locking Section 4, the system automatically generates Section 7 to proceed with the next step of the change control process. If the effectiveness evaluation is required, Section 11 will also be created at the same time.

The section can only be unlocked or locked by users with the QA Director privilege, ensuring proper control and oversight of this critical step in the process.

• Step 1: The system automatically generates Section 4 and sends email notifications to QA Director users.
• Step 2: The QA Director logs into the system, reviews the change, and assesses whether an effectiveness evaluation is required, filling in the relevant fields in Section 4.
• Step 3: The QA Director toggles the "Effectiveness Evaluation Required" option if necessary.
• Step 4: Once the fields are filled, the QA Director locks the section, triggering the system to automatically create Section 7 for the next step.
• Step 5: If an effectiveness evaluation is required, Section 11 is automatically generated alongside Section 7.
• Step 6: The QA Director has exclusive control over unlocking and locking Section 4.

Section 5: Implementation Plan

Section 5 is the stage where tasks are added, edited, or removed as part of the implementation plan for the change request. These tasks can be modified continuously until Section 7 is confirmed. Once Section 7 is confirmed, the implementation plan becomes final and can no longer be altered.

The following roles have the authority to add, edit, or remove tasks in Section 5:

• The Initiator of the change request
• Users with the QA Specialist and QA Manager privileges
• The Quality Director
• The head of the department that initiated the change
• The head of the department where the change will be applied

Each of the above users can access the change request record, open the Section 5 submodule, and manage the tasks within the implementation plan by adding, editing, or removing tasks as needed. This allows continuous refinement of the plan until it is finalized in Section 7.

Once Section 7 is confirmed, the implementation plan is locked, and no further changes can be made to the tasks. At this point, the tasks become final, and the plan must be executed according to the tasks defined in Section 5.

Task Management is a key part of the implementation phase, ensuring all necessary actions are outlined clearly and approved before execution begins.

There is no specific process for unlocking or locking Section 5, as it remains open for task modification until the confirmation of Section 7.

• Step 1: Authorized users open Section 5 to add, edit, or remove tasks in the implementation plan.
• Step 2: The tasks can be modified continuously until Section 7 is confirmed.
• Step 3: Once Section 7 is confirmed, the plan is locked, and no further changes can be made to the tasks in Section 5.

Section 6: Change Control Committee (CCC) Review

Section 6 is automatically created if the "Change Control Committee Review" option is selected in Section 3. Once Section 6 is created, the system automatically adds the members of the Change Control Committee (CCC) to the "Committee Members" submodule and sends email notifications to all committee members, instructing them to organize a meeting to proceed with the change review process.

During the meeting, committee members must:

• Open the change record in Section 6.
• Review the proposed change.
• Decide whether additional members should be added to the committee.
• Move Section 6 to the "For Approval" step once the review is complete.

While Section 6 is in the review phase, committee members can fill out important fields such as "Meeting Date", "Resolution", and "Comments/Recommendations". If these fields are not completed before the approval, they can be updated later after reopening the section, if necessary.

Before the change request moves forward for approval, the system automatically checks if tasks have been added in Section 5. If no tasks are found, the system prevents the change request from moving to the approval stage until tasks are defined in Section 5.

Once all CCC members approve the change, Section 6 is automatically updated to either Approved or Rejected. The system sends notifications to the change request initiator and other relevant users. If the request is rejected, the process ends. If the request is approved, Section 6 is locked, and it can only be manually reopened for further comments or updates if needed.

Approval and Rejection Process:

• CCC members move the section to the "For Approval" step after reviewing the change.
• The system checks if tasks in Section 5 are complete; if not, the approval process cannot continue.
• Upon approval by all members, Section 6 is automatically marked as Approved or Rejected.
• A notification is sent to the initiator, CCC members, QA Specialists, and QA Managers regarding the outcome.
• If the change is rejected, the process ends.
• If the change is approved, Section 6 is locked and can only be manually reopened for comments or updates.

Locking and Unlocking Process: Section 6 can only be unlocked or locked by the Change Control Committee (CCC). Members of the CCC are also the only ones authorized to move the section into the "For Approval" stage. Additionally, only the CCC can assign temporary members to participate in the approval process if necessary.

Section 7: Change Request Approval

Upon the automatic creation of Section 7, the system sends an email notification to the Quality Director for approval. The Quality Director must enter a comment and choose either the "Approved" or "Rejected" step.

• If the Quality Director selects "Rejected", the system marks the main change request as "Rejected", and the process is terminated.
• If the Quality Director selects "Approved":
  • The system checks:
    • Whether tasks have been entered in Section 5. If no tasks are found, approval is not allowed.
    • Whether Change Control Committee (CCC) Review is required for this change request. If it is required, and it is not approved yet, approval is not allowed. 
  • If tasks are present, the system creates a project linked to the main change request, along with tasks related to both the project and the change request.
  • The plan in Section 5 can no longer be modified, and the tasks from the plan are marked as "In Progress".

Upon approval, the system automatically generates Section 9, which tracks the execution of the tasks created in Section 5.

Process of Locking/Unlocking: This process does not apply to Section 7.

Task Management

After the approval in Section 7, the system automatically generates tasks and assigns them to the respective responsible users. Each assignee receives an email notification regarding their assigned tasks.

Tracking Progress and Status Changes

Task owners can update the status of their tasks by logging their progress in the Comment field. They can change the status to "In Progress", "Pending", or "Testing" when the task is complete. Moving a task to "Testing" requires a mandatory comment and triggers an automatic email to QA Specialists and QA Managers for review.

• "Assigned": Tasks are assigned to users who can begin execution.
• "In Progress": The task is actively being worked on by the assigned user.
• "Pending": Tasks that are blocked or waiting for dependencies are marked as pending.
• "Testing": When a task is completed and marked as ready for testing. This status change requires a mandatory comment.

When tasks are moved to "Testing", an automatic notification is sent to QA Specialists and QA Managers for review. If the task is approved, the QA Specialist or QA Manager can transition the task to "Completed". If the task is deemed incomplete, it is moved back to the "Assigned" status, and the task owner is notified via email for rework.

Completion of All Tasks

Once all tasks are moved to "Completed", the system automatically sends Section 9 ("Task Execution") for approval, and the process continues from there.

Comment Submission

To post a comment, the user must fill out the Comment field and then click the Save button to log the comment. Each status change must include a comment to track task progress.

Section 9: Task Execution

Section 9 is automatically created after the approval of Section 7 and initially remains in the status "Awaiting Task Execution". During this phase, tasks created in Section 5 are actively worked on and tracked. Once all tasks are either Completed or Rejected but closed, the system automatically transitions Section 9 to the "For Approval" status and sends an automatic email notification to QA Specialists for approval.

At this stage, QA Specialists and QA Managers have the following three options:

• Approve: The process moves forward to the next stage, and the system automatically generates Section 10.
• Reject: The process is terminated, and the change request is marked as "Rejected".
• Request Additional Tasks: The process loops back to Section 5, where new tasks can be added. The cycle repeats until all tasks are completed and approved, or the process is terminated.

If the option "Request Additional Tasks" is selected, the system automatically sends notifications to all users who have the ability to add tasks in Section 5. These include:

• The Initiator of the change request
• The Head of the Initiating Department
• The Head of the Affected Department
• QA Specialists
• QA Managers
• Quality Directors

New tasks are then entered into Section 5, and the process is monitored by QA Specialists, QA Managers, and the Quality Director. Once new tasks are confirmed by the Quality Director, Section 9 is updated to "Confirmed New Activities" status, and the system automatically generates these tasks within the Task Module.

After the newly created tasks are executed and closed, Section 9 transitions back to the "For Approval" step, and QA Specialists and QA Managers again have the three options: approve, reject, or request additional tasks. This cyclic process can repeat multiple times until all tasks are completed and approved, or the process is terminated with a rejection.

This cycle continues until a final decision is reached.

Process of Unlocking/Locking

This section does not involve any unlocking/locking mechanism.

Section 10: Change Finalization

Section 10 is automatically created after the approval of Section 9. At this point, the system sends an automatic email notification to the Quality Director for final approval.

The Quality Director opens Section 10, records a comment in the field "Remarks / Comments / Recommendations", and either approves or rejects the finalization of the change request:

• Reject: The system updates the main record of the change request to "Rejected" and the process ends.
• Approve: If Section 11 exists, which happens when the "Effectiveness Evaluation Required" button was activated in Section 4, the system sends Section 11 for approval to QA Specialists to inform them that an effectiveness evaluation of the change is required. Section 11 must then be approved or rejected based on documents verifying the effectiveness of the change in accordance with Section 4 when applicable. This is followed by reporting the completion of all planned activities and receiving feedback from the head of the department where the change was applied.

If Section 11 does not exist, the system updates the main record of the change request to "Completed" and the process is successfully finalized.

Section 11: Change Effectiveness Review

Section 11 is automatically created when Section 4 is locked, provided the "Effectiveness Evaluation Required" button was activated. After the approval of Section 10, the system sends an automatic notification to QA Specialists to inform them that an effectiveness evaluation of the change is required.

The QA Specialist can confirm the evaluation after entering the necessary information into all the activated fields:

• Confirm: Once the QA Specialist confirms the evaluation, the main record of the change request is moved to the "Confirmed" status and the process is completed.