Managing a change for Pharmaceutical, Biotech and Lifesciences companies is challenging with paper-based process.
In a GMP regulated environment where regulatory guidelines monitoring has a huge impact on the quality performance, paper based, or manual change control system has scope for human errors, unwanted repetitions, lack of traceability and many other challenges which effect turn-around time can drastically, productivity and ultimately the product safety or quality.
Some change control takes months and years for closure. These scenarios explain the need for Change Control Management Software for all Life Sciences companies.
Manual handling of Change Control procedures sometimes results in poor Change Control which in turn creates a huge risk of non-compliance.
Change Control plays a crucial role for a pharmaceutical company where strict adherence to regulatory bodies like FDA, MHRA environment is required to approve policies and procedures, it is a key factor in keeping manufacturing operations in a state of control.
Challenges with the current manual system
- Each change to previously approved requirements needs a review and authorization to keep the system in its original state of “proven stability” this takes a lot of time when the process is manual.
- When the change is at multi department, it’s challenging to manage and keep track of activities.
- A manual system makes it more difficult to update documentation, including revision history and to find /retrieve necessary data to support a change.
- The proposed change may be delayed when an outside record does not show revision history, or testing may be duplicated because documentation has not been updated with results of previous testing.
- Adequate training of employees in dynamic Change Control process is a prerequisite in FDA, MHRA and EU environments. When training management is not connected to the rest of the quality process, such as in manual systems, keeping training with current procedures that have changed can be difficult.
- Timely revert of temporary change controls is challenging.
- Manually need to check the logs/records for the effectiveness check dates.
Change Control Software Features
AmpleLogic Change Control Module is designed to maintain smooth communication and coordination in order to manage every significant step of Change Control process starting from Change initiation, approval, implementation till the closure of change control. Change request may be requested by internal user, client or supplier. Change Control Automation will improve the transparency across department throughout the Change Control lifecycle from initial to final step.
- This integrated system connects relevant department under one Change control on centralized information system with automated email notification, task assignment and escalation on pending actions to in-house team and suppliers.
- Transparent step vise change process e.g. Change request initiation, evaluation, implementation, verification and closure increase the accountability along with automated logs and audit trails.
- Auto capture of Initiation information such as Change type, Change Control number, initiated by, department, change required in, and change proposed for and justification, image or PDF document can be attached as an evidence.
- Software allow the users to select review points to evaluate the change and verification on the same after implementation.
- Option of primary and final classification on the change, auto communication to 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 control in training task.
- Reduces the costs of change management driven by unnecessary system, decrease the cycle time and operation cost by harmonized process in the organization.
- Integration with Quality Management modules CAPA and Learning Management System.
- Dashboard, Analytics and Reporting of Change Control yearly, monthly, classification vise for each process type.
Benefits of AmpleLogic Change Control software
AmpleLogic’s user friendly, workflow driven Change Control System Module allows the business user’s in adopting the software within 3 hours of training. It auto generates the tasks and sends timely reminder and escalations. The software is configurable, and it can accommodate the Customer Requirement in faster pace.
- 24*7 round the clock web-based application accessibility with highly secure centralized data base and end user access.
- Better process control and effective business communication with less human error and no human dependency.
- Assured timely approvals & closure with automated and predefined preventive notification, reminders and escalation.
- Online Initiation, approval, assessments and Verification of Change control process with electronic signature, activity stamp and addendum on existing change.
- Easy access on inbuilt electronic records notebook with desirable filter options on individual level.
- Traces and detailed transactions information on change control workflow, process, module and admin level activities.
- Smooth and easy communication with Customers and regulatory agencies like FDA, MHA and EU with inbuilt emailing functionality.
- 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 eye catching visual representation.
- Integration with email, AD, SAP/ ERP, Learning Management and Document Management system.
- 21 CFR Part 11 and EU Annexures 11 Complaint and Customization workflows suiting to customers process and on the fly Configurable changes in existing process