Change Control

Change Control Management or Change Control System

Change Control Management or Change Control plays a very vital role in pharmaceutical and life sciences companies, every change is reported by a change control process. When a change is made it is reported by a change control procedure and this is done before the product is approved by the company. This must be done to ensure that products are patterned to meet specific standards and for these standards to be thoroughly maintained. The standards are set by regulatory bodies like FDA, MHRA, EU Annex 11, WHO and it is pertinent that they be strictly adhered to.

Depending on the paper-based method for this process can be sometimes disappointing and inefficient as it takes more time and resources to get things done. Manual process also attracts many mistakes. This is why at AmpleLogic, Change Control has been made easy, effective and efficient with the introduction of the prestigious Change Control Management Software for all life science companies. This solution has been tried, tested and proven to be a lot more efficient than paper-based or manual solution when used for changed control.

Change control software will keep track of each and every change made to materials, methods, equipment and software and ensures that they are properly documented, validated, approved and traceable.

Change control is a very important part of pharmaceutical quality management system. Improper change control procedures will create a huge risk of non-compliance in many areas of quality system regulations.

To avoid any such deviations every change must be made according to approved policies and procedures

These can be divided into three types

  1. Minor
  2. Major
  3. Critical

Minor : A change that has no significant impact upon the quality, purity, strength, stability, safety or physical characteristic of the product.

Major : A change that has significant impact upon the quality, purity, strength, stability, safety or physical characteristic of the product.

Critical : A change that has a significant impact on quality and /or safety of the final product which requires the involvement of the corporate quality team

Challenges with the current manual system

  • Manual system is time-consuming considering that adjustments to standards requires reviews and due approvals to keep the system in a state of stability and work ability, this can be a bit too much for manual systems.
  • At multi-department level, management and activity tracking becomes extremely difficult.
  • Retrieval of existing data is difficult or almost impossible.
  • When documents are completed and documented, it is difficult to update them to make adjustments
  • When adjustments are finally made to documents, it is delayed by the system as it is very mechanical.
  • Regulatory bodies like the FDA, MHRA, WHO and EU Annex 11 are very dynamic, and they come up with new ideas frequently. It is difficult to train experts on how to adapt and adjust to these methods with a manual system.

Features of AmpleLogic Change Control Management Software 

Change Control System
Change Control Management Software Features

AmpleLogic Control Management Software is painstakingly developed taking some very vital features into consideration. Despite the fact that it is automated, it is designed to ease communication and coordination in order to make the change control process as smooth and easy as possible. AmpleLogic pays attention to the slightest of details as every feature are well documented.

Structured and consistent approach towards managing change

  • The entire process starts by making a `change request`. This action can be carried out by an internal user, client or supplier. Next, another option called `the Change Control Automation` improves the transparency across department throughout the change control life cycles from the initial to the final step.
  • This system is completely automated with good communication and information platform, email notifications, task management and escalation on pending actions to in-house team and suppliers. All these departments are properly integrated into to one system.

Documenting the details of change

  • The system has a very transparent step-wise change process e.g. Change request initiation, evaluation, implementation, verification, and closure increase the accountability along with automated logs and audit trails.
  • AmpleLogic change management solution auto-captures initiation information such as change type, Change Control number, who initiated it, department, change required and change proposed for and justification, image or PDF document can be attached as evidence.
  • This automated change control management solution allows users select review points to ascertain the change and verification on the software after implementation. Hence, it permits readjustments and updates.

Documentation of change approvals and implementation

  • The control change can be classified based on primary and secondary classification and it allows auto-communication to a cross-functional team, clients or contract giver.
  • The system monitors and reevaluates the entire control process to the very end.
  • It allows for multiple change requests on multiple products at a time.
  • Implementation of control can be made at a faster rate due to the option of subsequent or parallel implementation.

Seamless Integration

  • Can be easily integrated with Learning Management system, any change in the document will enable the option for new change control in the training task.
  • If any training is required for the initiated change control then it shall trigger to the LMS and if any document/SOP revision is required it shall be triggered to DMS
  • Reduces operation cost and cost of change management that would have been driven by an unnecessary system and this, in turn, decreases cycle time to the barest minimum.
  • AmpleLogic change control management integrates seamlessly with quality management modules such as CAPA and other quality process automation modules.

Benefits of AmpleLogic Change Control Management Software

AmpleLogic Change Control Management Solution is user-friendly as it is workflow-driven. It is so easy to operate that Its Change Control System Module allows the business user adopt the software within 3 hours of training. This system auto-generates the tasks, sends a timely reminder and escalations when needed. The software is also configurable and can accommodate the Customer Requirement at a faster pace. Below are some of the benefits AmpleLogic Change Control Management software provides:

Automated Alerts

  • Timely approvals and closures with its fully automated and predefined preventive notification, reminders, and escalation for efficiency and accuracy.
  • If the change control is not approved within time line then system shall ask for delay justification. Even before the system asks the user also has the provision to take the justification.
  • For each and every action item there will be a target date for completion, if the task is not completed within the target date, system shall ask the user to take the extension.

Easily Accessible and High Secure

  • 24*7 application accessibility with highly secure centralized database and end-user access.
  • For easy access on inbuilt electronic records notebook with desirable filter options on individual levels.
  • Online initiation, approval, assessments, and verification of Change control process with an electronic signature, activity stamp and addendum on existing change.

Efficient and Transparent

  • Better process control and effective business communication with less human error and no human dependency. This is a massive upgrade to the paper-based system that is mechanical and allows for multiple errors.
  • Detailed transactions information on change control workflow, process, module, and admin-level activities are thoroughly tracked by this software solution.

Better communication

  • Inbuilt emailing functionality that allows for smooth and easy communication with Customers and regulatory agencies like FDA, MHRA, and EU Annex 11.

Reports & Visual representation of Metrics

  • Quality Metrics reporting and traceability trends to check the Unit/Department Productivity and Performance status that provide up to date graphical report like pending tasks, completed tasks, personnel involved, time frames with an eye-catching visual representation.
  • This Change Control Module provides options like Dashboard, Analytics and Reporting of change control yearly, monthly, classification vise for each change control process type.

Few examples of various reports

  • Individual status of change control
  • Change control vs proposed area
  • Individual department wise change control
  • Department wise no CC logged for last 12 months
  • Extension wise CC implementations
  • Action wise extension taken

many more useful and insightful reports can be generated from the system

Seamless integration with other systems

  • Easy and seamless integration with other systems like email, AD, SAP/ ERP, Learning Management and Document Management system.
  • 21 CFR Part 11 and EU Annex 11 Complaint
  • Customization workflows suiting to customers process and, on the fly, Configurable changes in the existing process
Change Control Management
Benefits of Change Control Management Software

Kindly contact us for more information about how your organization can benefit from AmpleLogic Change Control Management System