Deviation Management

Deviation Management, and Tracking Software Solution

Deviation Management is used for the Pharma industry and Biotech industry. As of now many pharmaceutical industries and biotech industry work on unplanned and planned on a daily basis. While dealing with regulatory bodies like the US FDA and MHRA. They need to ensure that all the deviation management must be logged, circulated, studied and responded correctly to each associated process.

A strong CAPA system needs an efficient deviation handling system to evaluate the events based on the associated risk and act accordingly in a timely manner and also to verify the effectiveness of the actions taken.

In a GMP (Good Manufacturing Practice) 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 form critical in order to correct, investigate and prevent similar with an effective CAPA.

But the manual deviation system involves a lot of paperwork and is often characterized by slow investigations, approval delays, lack of traceability, ineffective communications and ultimately repeated. This scenario shows the need for automated Deviation Management Software for all Life Sciences companies.

Biochemical & Pharmaceutical Deviation Automation Software

AmpleLogic Deviation Management software automates efficiently, the manual process of handling all forms of deviations (Planned/Unplanned) from those reported through investigations, CAPA implementations, and closures. Features involved include Quality metrics and drag and drop report generator which gives the study of all the activities related to each process like human error, equipment, etc. This contributes to the continuous improvement of Quality in Pharmaceutical Companies.

Deviation handling plays a vital role in assuring the quality of products with adherence to 21 CFR part 11 and EU Annex 11 which is an essential aspect of an automated Centralized Quality Management System.

AmpleLogic Deviation Handling Software Features

  • Option to select the type and automatic display alteration of initiation information.
  • Product or Batch impact mapping.
  • Linking with repeated deviations based on company workflow.
  • Assignment of CAPAs to individuals, department or groups CAPA, action plan, action items are automatically assigned from application and option to attach additional action items if any.
  • Easy to use and workflow automates review & approval process while E-mail notifications are automatically sent to responsible users for verification and escalation.
  • End to end audit trail ensure to comply with part 11 requirements including E-signature, data integrity, record traceability, and data security.
  • Dynamic deviation reports to check the dependency and linking with other modules as per US FDA quality modules.

AmpleLogic Deviation software system Benefits

Deviation Handling

  • Enterprise-wide 24 x 7 accessibility to Deviation Management System that allows access from any point within the organization at any time.
  • Harmonizing the entire process of quality management by continuously integrating with other quality processes like CAPA, Change Control, etc.
  • Standardized Root Cause Analysis (RCA) and a distinct area to describe it with different methods of evaluation such as fish-bone method, 5 why’s analysis, etc., helps in maximum output.
  • Impact to predefined Critical Quality Attributes (CQA) and Critical Process Parameters (CPPs) can be easily identified with AmpleLogic Deviation Management Software.
  • Depending upon the priority of deviations (high, medium and low) actions can be taken.
  • The information gathered over time through investigations contains a wealth of data that can be used for continuous improvement, increasing productivity, and reducing the re occurrence of deviations.
  • Data integrity, compliance with FDA norms, 21 CFR part 11 and EU Annex 11 is one of the biggest challenges for pharmaceutical manufacturing companies, relying on AmpleLogic Deviation Management system resolves all the challenges.
  • Centralized access and integration with Document Management system allow getting supporting documents, SOP and pre-saved templates.
  • Live to track 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 another quality system.
  • Customizable workflows, deviation reports according to the deviation templates of the company to suit your current process.
  • Metrics reports or trends that are exclusively analytical and visually eye-catching
Deviation - Planned Deviation
Deviation – Planned Deviation

Kindly contact us for more information about how your organization can benefit from AmpleLogic Deviation Management