In a GMP regulated environment where all activities and daily operations are governed by documented written procedures, there is always a possibility to deviate from these written procedures in a planned or unplanned manner. Reporting of these Pharmaceutical manufacturing process specific deviations forms critical in order to correct, investigate and prevent similar deviations with an effective CAPA. But the manual deviation system involves a lot of paper work and is often characterized by slow investigations, approval delays, lack of traceability, ineffective communications and ultimately repeated deviations. This scenario shows the need for an automated Deviation Management Software for all Life Sciences companies.
Pharmaceutical Deviations Automation Software
AmpleLogic Pharma Process Deviation Management Software automates the current process of handling deviations from deviation reporting through investigation, implementation of associated CAPA and closure. This enables an organization to track deviations in real-time, pre-define responsibilities, control overdue/ delays and bring traceability across other Quality Systems that drive the Deviation Management System to be functionally effective.
The Deviation Management and Tacking Software is designed to provide seamless capabilities in linking the deviation quality system with critical quality systems such as CAPA, Change Control and others. For example all associated CAPAs originating from deviation are initiated and managed for effective closure at CAPA Management.
With configurable workflows and flexible workflow components/ sections it is easy for the Deviation Management Software to be transitioned into your current deviation process within in a short period. In-depth Deviation tracking and trending is made available at the click of a button with Summary Reports and Metrics Reports. Deviation Summary Report gives real-time summarized information within the selected deviation and deviation metrics reports bring high-level and in-depth performance visibility of Deviation Closures across the organization at any given point.
Besides providing best approach for effective closure of deviations, the Deviation Management 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 Deviations Tracking Software
This Deviation Management Software solution was developed based on extensive research on deviation guidelines from various regulatory agencies, in developing deviation software which is practical and problem oriented with these core benefits:
- Enterprise wide 24 x 7 accessibility to Deviation Management System that allows access from any point within the Organization at anytime
- Total compliance with 21 CFR part 11
- Live tracking of deviations with automated alerts and notifications
- Faster Deviation Reporting with simplified auto selections and reduced manual entry
- Accelerated Investigations with assignable investigation tasks and root cause analysis tool
- Improved Deviation Closure timelines with best practiced workflows
- Capabilities to integrate and establish closed-looping with other Quality System
- Customizable workflows to suit your current process
- Customizable Deviation Reports according to the deviation templates of the company
- Metrics Reports or Trends that are exclusively analytical and visually eye catching
Apart from being an industry standard and an effective Deviation Management Software, the deviation control system has several key features that enable organization and users to continuously improve the way deviations are handled
Simplified Deviation Reporting
Reporting an unplanned deviation or initiating planned deviation is made simple with easy to define fields that allow defining a deviation comprehensively but without much effort data entry effort from initiators.
Investigation & Root Cause Analysis
The Root Cause Analysis allows tasks assignment to the investigators and across the departments based upon criticality of the observation. These investigators in turn can create tasks and send to participants for response. The responses are evaluated for identification of root cause and submitted for CAPA Proposal. Due dates set ensure targeted closure of tasks and auto escalation upon overdue which maintains the nature of the Root Cause Analysis to be robust and effective.
Planned Deviations Review
Planned Deviations are handled through separate workflows after deviation reporting that allows them to be evaluated for repetitive nature, impact assessment and routing for approval prior to implementation.
Integrated Quality Systems
The Deviation Management Software is designed to be flexible in integrating with other quality systems and establish a seamless and controlled flow between deviation management and rest of the quality systems specially CAPA Management. The CAPAs originating can be initiated and closed at the CAPA Management with enabled status tracking at the Deviation Management.
Automated Alerts & Notifications
This is practical feature that ensures that the 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 to the concerned authority and helps resolve the issue.
Industries that can benefit from our Solution
- Medical Devices
- Contract Manufacturing
- General Manufacturing
- Food & Beverages