Change Control Management Software
In the Life sciences Industry Change Control plays an important role. Being in GMP Environments Pharmaceutical Companies must report every change. When a change is made by adding a new procedure or changing an existing procedure it must be approved by appropriate authorities.
A pharmaceutical company that follows strict adherence to the policies laid down by regulatory authorities such as the US FDA and MHRA, will only proceed to make changes to any existing product after obtaining an approval from the regulatory bodies.
Managing a change in Pharmaceutical, Biotech and Life Sciences companies is challenging when the process is paper-based. In a cGMP regulated environment. Regulatory guidelines monitoring has a huge impact on quality performance. Paper-based, or manual change control systems have scope for human errors, unwanted repetitions, lack of traceability and many other challenges which affect turn-around time. This can drastically impact productivity and ultimately the product safety or quality.
Manual Change Control Issues in GMP Environments
- Some change controls takes months and years for closure. These scenarios explain the need for Change Control Management Software for Life Sciences companies.
- Manual handling of Change Control procedures sometimes results in poor Change management which in turn creates a huge risk of non-compliance.
- When the change is at the multi-department level, it’s challenging to manage and keep track of activities.
- A manual system makes it more difficult to update documentation, including detailed history of revisions for the product and the ability to easily retrieve relevant information required for implementing the changes.
- Adequate training of employees in the dynamic Change Control process is a prerequisite in USFDA, MHRA and EU environments. To make the change effective the impacted group must complete relevant Manual tracking of training completion is also challenging.
- Timely revert of temporary change controls is challenging.
- Manually need to check the logs/records for the Status on the Existing Change Controls
AmpleLogic Change Management Software Module is designed for GMP driven Pharmaceutical and Biotech Industry to streamline communication procedures and improve coordination for better management of every significant step of the Change Control process starting from Change initiation, approval, implementation until the closure of change control. The change request may be initiated by an internal user, client or supplier. Change Control Automation will improve transparency across departments throughout the Change Control life cycle from the initial to the final step.
The typical flow in the Change Control Software is as follows:
- Change Initiation and acceptance before change evaluation
- Evaluation of the change through evaluation activities.
- Proposed change implementation and implementation review before closure
- Tracking of change controls and implementation activities
The Change Control Software is built on AmpleLogic LOW CODE PLATFORM. The visual development approach helps in automating manual and paper-based processes to increase accuracy and quality while reducing costs
GMP Change Control Software Features
- This integrated system connects the relevant department under one Change control on the centralized information system with automated email notifications, task assignment, and escalation on pending actions to in-house team and suppliers.
- Transparent step-wise change process includes initiation of the change request, evaluation of the change, implementation, and verification of the change followed by closure, increases accountability along with automated logs and audit trails.
- Change Control solution will auto capture Initiation information such as Change type, Change Control number, initiated by, department, change required in, and change proposed for along with justification. It also supports the attachment of image of PDF documents as proof.
- Change Management software allows users to select review points to evaluate the change and verify the same after implementation.
- The option of primary and final classification on the change, through auto communication to a cross-functional team, client or contract giver.
- Manage all the aspects of the Change process starting from initiation till the end. Option to propose more than one change request under one change control number. Implementation could be subsequent or parallel for faster implementation based on the dependency.
- Easy integration with Learning Management system., Any change in the document will enable the option for new change controls in the training tasks.
- Reduces the costs of change management by automating several processes in Change Control. It also decreases the cycle time and operational costs incurred in change control by harmonizing the processes followed by the the organization.
- AmpleLogic Change Control software can be integrated with Other eQMS modules like CAPA, Learning Management System and DMS Software.
- Dashboard, data for analytics, along with reporting the change control on a monthly or annual basis and classification of change controls for each process type.
Change Control Automation benefits in Pharmaceutical and Biotech Industry
AmpleLogic’s Change Management Solution is a user-friendly, workflow-driven Change Control System Module which allows the businesses to adopt the software within 3 hours of training. It auto-generates tasks and sends timely reminders and escalations. The software is configurable, and it adapts to the business requirements at a quick pace.
- 24*7 access to the web-based application which features a highly secure and centralized database and end-user access.
- Better process control and effective business communication with less human error and no human dependency.
- Assured timely approvals & closures with the help of system generated notifications and reminders along with effective handling of escalations.
- Online initiation of change control request followed by approval, assessments and verification of the change control. The procedures include validation through electronic signatures and activity stamps. It also includes an addendum on the existing change.
- Users can easily access information related to a change control request by going through the electronic records. The data can be filtered on an individual level.
- This Change Control Management Solution tracks all activities on the change control workflow to provide users with detailed information of the process along with admin level activities.
- Smooth and easy communication with Customers and regulatory agencies like FDA, MHRA, and EU Annex 11 with inbuilt emailing functionality.
- Quality Metrics reporting and traceability trends to check the Unit/Department efficiency in handling activities related to change control. It also tracks the performance status of the departments through graphical representation of information like pending and completed tasks and the employee involved or responsible for the tasks and the time frames allocated for the activities.
- 21 CFR Part 11 and EU Annexures 11 Complaint and Customization workflows suiting to customer’s process and on the fly Configurable changes in the existing process
AmpleLogic GMP Change Management Software will comply with Electronic Record Standards defined by TGA, CDSCO, HEALTH CANADA, MCC, ANVISA, EMEA, SFDA, NAFDAC, MEDSAFE, MHLW, MCAZ, SWISSMEDIC, KFDA and MoH
Other industries that can take advantage of Product or Process Change Management Software
- Medical Devices
- Contract Manufacturing
- General Manufacturing
- Food & Beverages