Deviation Management

Deviation Management Software

In the Life Sciences Industry, Deviation management is a part of the guidelines outlined in Good Manufacturing Practices. All the deviations are potentially about the differences between observed value and expected or normal value for a process or product condition. Immediate attention must be paid to deviations with complete evaluation and an immediate corrective action which can prevent recurrence.

Pharmaceutical and Biotech companies must demonstrate strict adherence to current Good Manufacturing Practices related to the procedures and controls that govern product manufacturing in the pharmaceutical and drugs regulatory Industry. Any non-adherence must be recorded as a deviation.

As of now many pharmaceutical industries and biotech industries work on unplanned and planned deviations on a daily basis. When they are required to address regulatory authorities including the US FDA and MHRA, they need to ensure that all deviation management information is logged accurately and information about them is circulated to the necessary departments who can study and respond correctly to address the deviations.

In an organization that adheres to GMP guidelines, all activities and daily operations are carried out in compliance with documented procedures. When this documentation is available in written for only, there is a possibility to deviate from these procedures – planned or unplanned. It is important to report these pharmaceutical manufacturing process deviations in order to correct, investigate and prevent them with an effective CAPA.

But the manual deviation system involves a lot of paperwork and is rife with delays, slowed-down investigation procedures and an inability to track the deviation management process. It may also involve ineffective communications and ultimately repeated deviations. This scenario shows the need for automated Deviation Management Software for all Life Sciences companies.

AmpleLogic Deviation Automation Software

AmpleLogic Deviations Management Software has been developed on LOW CODE PLATFORM. It automates the manual process of handling planned and unplanned deviations from deviation reporting through investigation, CAPA implementation, and closure. Quality metrics, along with a drag & drop report generator provides a detailed study of all activities related to each process like human error, equipment, etc.

Deviation handling plays a vital role in assuring the quality of products with adherence to 21 CFR part 11 and EU Annex 11. This helps organizations create a strong and efficient centralized quality management system. .

As a result, it contributes to the continuous improvement of Quality in Pharmaceutical Companies.

Electronic  Deviations management Software Features

  • Users have the option to choose the type of initiation information along with automatic alterations on the display of data.
  • Pharmaceutical product or Batch impact mapping.
  • Linking with repeated deviations based on company workflow.
  • Assigning CAPAs to an individual or a department. Once the CAPAs are assigned, the system automatically assigns action plans and action items along with the option to attach additional action items if any.
  • The workflow is user-friendly and is designed to support automation of the review and approval process with the help of email notifications sent to responsible users for verification and escalation.
  • Organizations can depend on the software for a complete audit trail that supports compliance with part 11 requirements. The system also supports e-signatures, data integrity, and data security for better compliance. Additionally, it makes record traceability relatively easy.
  • Dynamic deviation reports to check dependency and links with other modules as per USFDA quality modules.

GMP Deviation Software Benefits

  • 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 quality management process by easily integrating the deviation software with other quality processes and systems like CAPA, Change Control, etc.
  • Supports standardization of the Root Cause Analysis (RCA) procedures providing users with distinctive fields to clearly describe it with different methods of evaluation such as fish bone method, 5 why’s analysis, etc., helps in maximum output.
  • Users can easily identify the impacts of the deviation on predefined Critical Quality Attributes (CQAs) as well as Critical Process Parameters (CPPs) with the help of the software.
  • Actions can be taken based upon the priority of deviations (high, medium and low).
  • The information gathered over time through investigations helps organizations put together scores of intelligent information which supports improvements in existing processes, higher operational efficiency and lower re-occurrence of deviations.
  • One of the biggest challenges faced by organizations in the Life Sciences industry, is the growing need for data integrity, and adherence to regulatory guidelines laid down by FDA, 21 CFR part 11, and EU Annex 11. AmpleLogic Deviation Management Software has been designed specifically to address these challenges and improve productivity.
  • The system supports centralization and integration with the Document Management System to help users easily access supporting documents, pre-saved templates and Standard Operating Procedures (SOP) relevant for deviation management.
  • It enables live tracking of deviations and supports automation of alerts and notifications.
  • Better reporting of deviations with minimal manual entries.
  • Faster outcomes supported by the root cause analysis tool and the ability to electronically assign investigation tasks
  • Accelerated closure of deviations with the help of proven workflows
  • The ability to integrate the software with other quality system for closed looping of the deviations and other dependent actions carried out through related quality systems.
  • The workflows can be customized as per the organization’s requirements and reports can be generated in accordance with the deviation templates of the company to suit your current process.
  • The software supports graphical and visual representation of metrics, reports and trends to help organizations get a complete view of the deviation management process.

Our Process Deviations Automation will also 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 Deviations Automation Software

  • Biologics
  • Medical Devices
  • Chemical
  • Contract Manufacturing
  • General Manufacturing
  • Food & Beverages
Deviation - Planned Deviation
Deviation – Planned Deviation

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