Deviation Management

Deviation Management Software

Deviation management is a subset of the rules stated in good manufacturing practices in the life sciences industry. All deviations may be related to disparities between actual and expected or normal values for a process or product condition. Deviations require immediate attention, comprehensive examination, and immediate remedial action to prevent a recurrence.

Companies in the pharmaceutical and medicines regulation industries must conform strictly to current Good Manufacture Practices (GMPs) relating to the processes and controls that regulate product manufacturing. A deviation must be documented for every instance of non-adherence.

Many pharmaceutical and biotech companies currently operate on a daily basis with planned and unplanned deviations. Any time they are confronted by a regulatory authority, such as the FDA or MHRA, they must make sure that all deviation management information is recorded correctly and distributed to the appropriate departments so that the deviations can be studied and addressed appropriately.

All activities and everyday operations in a GMP-compliant organization are conducted following established protocols. A deviation from processes, whether intended or not, is likely if documentation is only available in written form. It is important to report these irregularities in pharmaceutical manufacturing processes so that a CAPA may be adopted to fix, investigate, and avoid future issues.

However, the manual deviation system is time-consuming and prone to delays, slow investigative procedures, and the inability to monitor the deviation management process. Ineffective communications and frequent deviations may also be factors. Every Life Sciences company can benefit from Automated Deviation Management Software, as in this case.

AmpleLogic Deviation Automation Software

The AmpleLogic Deviations Management Software was built on a LOW CODE PLATFORM, and it automates the manual processes of working with intended and unexpected deviations, starting with deviation reporting and continuing with inquiry, CAPA application, and closure. Quality metrics, with a drag-and-drop report generator, allow a thorough examination of all activities associated with each process, such as human error, equipment, and so on.

Managing deviations is critical to ensuring that products meet 21 CFR part 11 and EU Annex 11 quality standards, and this facilitates the creation of a solid and effective centralized quality management system by organizations.

Consequently, it brings about a solid and effective centralized quality management system.

Features of the Electronic Deviations Management Software

  • 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 designed to provide the best possible user experience and to make the review and approval process more automated by sending email alerts to the appropriate personnel for verification and escalation
  • The software offers a reliable audit trail that meets the requirements of part 11, and which organizations can trust. For improved compliance, the system is enabled for e-signatures, data integrity, and it simplifies the process of tracing records
  • Determining dependencies and connections with other modules based on USFDA quality modules using dynamic deviation reports.

Advantages of GMP Deviation Software 

  • Deviation Management System can be accessed from anywhere in the company, at any time, 24 hours a day, seven days a week.
  • Integrating the deviation software with other quality processes and systems such as CAPA, Change Control, and so on simplifies the overall quality management process.
  • Root Cause Analysis (RCA) processes can be regulated by giving users unique fields from which they can explain it clearly with different assessment methods like the fishbone approach, 5 why’s analysis, and so on. This helps in getting the most out of the analysis.
  • The system allows users to quickly detect the effects of deviations on established Critical Quality Attributes (CQAs) and Critical Process Parameters (CPPs) easily.
  • The priority of deviation (high, medium, or low) is influences how the action is taken.
  • Organizations are able to compile a wealth of intelligent data that would reduce the recurrence of deviation, and improve the current processes and operational efficiency through information gathered over time.
  • There is a rising demand for data integrity in the Life Sciences industry, as well as adherence to FDA, 21 CFR part 11, and EU Annex 11 regulatory standards. AmpleLogic Deviation Management Software was created to help organizations overcome these issues and boost their productivity.
  • The system can be connected and used with the Document Management System, allowing users to seamlessly access reference documents, re-saved templates, and Standard Operating Procedures (SOP) related to deviation management.
  • It allows for the automation of alerts and notifications as well as the live tracking of deviations.
  • The system makes it easy to report deviations and with fewer manual entries.
  • Results are gotten quicker as a result of the root cause analysis tool, and the ability to assign investigative assignments electronically.
  • Closure of deviations is faster with the aid of established workflows.
  • The software can interface with other quality programs for closed looping of deviations as well as other reliant actions performed  by related quality systems.
  • The system allows workflows to be tailored to meet the needs of the organization, and reports can be created using the company’s deviation templates to fit your existing process.
  • Metrics, reports, and trends can all be represented graphically and visually in the software, allowing organizations to gain a comprehensive understanding 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, toSFDA, NAFDAC, MEDSAFE, MHLW, MCAZ, SWISSMEDIC, KFDA, and MoH.

Other industries that can benefit from Deviations Automation Software are

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

For more information on how AmpleLogic Deviation Management can benefit your company, please contact us.