Regulatory Compliance Management Software

The Regulatory Compliance Management System is a one-of-a-kind web-based solution from AmpleLogic. It contributes to operational clarity by organizing a set of internal controls that are carried out accurately in accordance with the constantly changing requirements. These criteria are derived mostly from regulatory standards, policies, legislation, and regulations that have been made public to facilitate manufacturing.

Compliance Management Software

This software solution records and controls these policies and ensures that they are rigorously adhered to, and given the frequency with which policies change, this solution is extremely relevant. It is critical in assisting organizations in managing changes to applicable regulations such as environmental, health, and safety to assist them in reducing or eliminating compliance deviations and non-compliance risks.

Several global organizations face the risks of non-compliance with statutory rules, both locally and globally. Especially in the life sciences, this has been a major concern for these organizations during production and harms the reputation of these brands.

Fortunately, the AmpleLogic Regulatory Compliance Software Solution was created to address all of these issues and, in particular, to assist organizations in handling all of their compliance obligations. This solution aids in fulfilling the production requirements of the business streamlines manufacturing processes to keep them intact, and also aids in minimizing the number of errors that are caused by the manual process as well.

Challenges of Compliance Management in Life Sciences & Pharmaceutical Industries

  • Our team of experts conducted an extensive study and discovered that firms employing the manual approach encounter several issues, including:
  • Due to the mechanical nature of the manual process, it is impossible to document significant information about compliance activities in registers or logbooks
  • Executives of organizations may find compliance status records, including prior compliance status reports, to be far too complex to quickly sift through.
  • Because there are no alerts or notifications in manual compliance management, license data and renewal dates are easily forgotten.
  • It’s difficult to see license details in reports, so it is hard to tell whether they don’t meet regulatory standards or laws.
  • To support compliance management, hundreds of excel spreadsheets may be compiled. This takes a long time and is rife with potential mistakes.
  • In the manual process, it is possible that the old systems and tools were not built to meet today’s standards

Features of AmpleLogic Pharmaceutical Compliance Software System

  • Uniquely created, the Compliance Management Software has business workflow processes with a high degree of technicality built-in. It makes it possible for clients to easily customize predefined processes to develop a workflow specifically tailored to their company’s needs.
  • Compliance Solutions complies with the requirements of 21 CFR Part 11. As a result, it complies with and meets regulatory norms.
  • The AmpleLogic regulatory Compliance Management Software solution is simple to use and maintains a high level of user security. Important features like electronic signatures, audit trails and multi-password security along with time-stamped activity are all included in this system.
  • A feature of the system allows it to be used in the user’s native language, which eliminates language barriers and improves translation.
  • The Interactive dashboards that come with the AmpleLogic System make it user-friendly. This is important in compliance management since all departments in the organization have real-time visibility into the reports.
  • When certain tasks must be completed, certain users are automatically notified via tasks, triggers, and notifications. Additionally, these notifications can be configured for status updates, requests, issues, complaints, and assignment.
  • The Compliance Management system ensures that compliance data or information is not tampered with. It also keeps track of any alterations made to any of the records in the system as a whole.
  • With this Compliance Management Solution, organizations can develop custom reports and have the system automatically generate compliance reports for your audits

AmpleLogic Regulatory Compliance Management Software complies with Electronic Record standards defined by TGA, CDSCO, HEALTH CANADA, MCC, ANVISA, EMEA, SFDA, NAFDAC, MEDSAFE, MHLW, MCAZ, SWISSMEDIC, KFDA, and MoH

Our On-Premise and Cloud-Based Compliance Management Software can also be used in the following industries:

  • Biologics
  • Medical Devices
  • Contract Development and Manufacturing Organization (CDMO)
  • Chemical Industry
  • Contract Manufacturing
  • Generics
  • General Manufacturing
  • Contract Research Organization (CRO)
  • Food & Beverages

Please get in touch with us if you’d like to learn more about how AmpleLogic Compliance Management System Software can improve your company’s productivity.

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