Life Sciences Companies especially Pharma & Biotech have always desired for a simple, robust and flexible Change Control Management to effectively implement changes within their regulated GMP environment. The current paper based or manual change control system leaves scope for human errors, unwanted repetitions, lack traceability and many others which can drastically effect turn-around time, productivity and ultimately the product safety or quality. This scenario explains the need for Change Control Management Software for all Life Sciences companies
Change Control Management and Tracking Software
This Change Control Software provides an optimal solution to manage and control change requests within the regulated environment of an Organization by initiating, evaluating and implementing changes with verification over an automated and streamlined Change Control Software System. Any type of change can be proposed, routed for acceptance, evaluated based upon change type including classification, time lining implementation, appropriate reviews, recommendations and implementation approval and many other useful features are provided through workflows at this Change Control System . Approved Change is implemented through pre-defined implementation tasks and Change Control Tracking till closure. Defined timelines along with overdue controls ensure effective and quick change control closure.
The Change Control Software is designed to fully integrate with other critical Quality Systems such as CAPA to manage CAPA activities. The corrective or prevention actions which require changes are initiated, evaluated and implemented at Change Control Management with enabled tracking at the source Quality System i.e. CAPA Management.
With configurable workflows and flexible workflow components/ sections it is easy for the Change Control Management System to be transitioned into your current change control process within in a short period. Extensive Change Control Tracking and Analysis is made available at the click of a button with Summary Reports and Metrics Reports. Summary Report gives real-time summarized information within the selected change control and metrics reports bring high-level and in-depth performance visibility in closing change controls effectively within the timeline across the organization at any given point.
Besides providing best approach for effective management of change controls , the Change Control software is in total compliance with electronic records and management regulations such as 21 CFR Part 11, by providing audit trails, e-signatures, controlled printing, controlled access, records management and archival in accordance to regulatory standards and policies of an Organization.
Advantages with Change Control automation
This Change Control Software was developed based on extensive research of Change Control guidelines from various regulatory agencies and yet is flexible to be practical and problem oriented with these value-added core benefits:
- Enterprise wide 24 x 7 accessibility that allows change to be proposed and initiated at any time using this change control software
- Three phase simplified process – Initiation, Evaluation & Implementation
- Wide applicability to accommodate all types of changes from minor typographical corrections to critical Facility modifications
- Workflow sections specific to Change Type to set the best path for thorough evaluation and effective implementation
- Automated routing for Corporate review based upon criticality of change proposed
- In build Change Evaluation workflow to handle the Impacted documents and also the requirement of new Documents IntroductionLive tracking and traceability of changes with status, automated alerts and notifications
- Capabilities to integrate and establish closed-looping with other Quality Systems
- Customizable workflows to suit your current process
- Metrics Reports or Trends that are exclusively analytical and visually eye catching
Apart from being an industry standard and effective Change Control management solution, the system has several key features that enable organization and users to continuously improve the way changes are controlled and managed.
Change Control Automation and Tracking Key Features
Simplified Change Initiation
Often change initiators struggle in getting to describe the change to its closest meaning and end up with description that is not simple. The easy to define fields and logical data capture ensures that the change to be proposed is described is simple and informative.
When there is a similar change across multiple products and simultaneously, it is challenging for a manual system to track them and their change control flow. But this change control software allows selection and addition of impacted products to change initiation through which all product related changes are initiated in one go.
The feature allows the initiator to relate the proposed change into any one of the available types of change. These available change type selections are provided based upon extensive research across wide range of companies so proposed change can be exactly related to the one among available change type.
The feature allows a change to be classified into minor, major or critical so as to change the workflow strategy and automation as per the selected classification. The system ensures that minor changes are implemented in short period and critical changes are accelerated to close within targeted timelines as per business rules. Besides the system has capability to auto select the change classification based upon the change title.
Changes can be categorized as temporary or not which makes it easy to get back to temporary changes and has ability to prioritize changes based upon the nature of change such as routine or emergency
Quality Systems Switch
With cross-functional workflows that move through Quality Systems and loop back it is an essential need to make the interface as user-friendly as possible. The change control software allows a swift switching between Quality System with the harmonized single user-interface across all Quality Systems.
In-built Document Management
Changes are synonymous with document changes. Therefore there arises document that needs to be changed, approved and implemented to coordinate the proposed change. The change control software has feature to handle changes in impacted documents and also creation of new documents which can drafted, routed and approved.
This feature comes with an understanding that within a complex change, not all sub-changes are implemented simultaneously. In some cases there is a dependency between sub-changes and in some others there needs to be a sequence between any set of the sub-changes. So implementation tasks can be relatively inter-connected to establish dependency.
Complex changes involve a lot of documents that need changes across different departments. It makes sense to meaningfully group these documents to have an organized structure and access.
Integrated Quality Systems
The Change Control system is designed to be flexible in integrating with other quality systems and establish a seamless and controlled flow between change control and rest of the quality systems specially CAPA Management. The CAPA activities related to change control can be initiated, evaluated and implemented at Change Control System.
Disintegrating implementation into implementation tasks that can are assignable, traceable and manageable to implement and verify changes efficiently with accountability.
Automated Alerts & Notifications
This feature ensures that users are automatically communicated at defined frequencies and at defined workflow steps about the approaching target date for required actions. Users are notified directly through follow-up e-mails that are sent automatically to the user e-mail account. Besides the system auto escalates the overdue and helps resolve the issue.
You can feel free to reach us to know more about AmpleLogic Change Control System and get your questions answered.
Industries that can benefit from our Solution
- Contract Manufacturing