Compliance Management Software for Pharmaceutical Industry
AmpleLogic Compliance Management System is one of our unique web-based solutions. It helps ensure that there is clarity of operations by organizing a set of the company’s internal controls done accurately in compliance with the ever dynamic requirements. These requirements are basically from Regulation standards, Policies, Acts, codes, etc. made available to enhance production. This software solution stores and control these policies and ensures that they are strictly complied to and the fact that policies change frequently makes this solution very relevant. It is essential in enabling companies manage changes to applicable laws like environmental, health, safety, etc. in order to help them curb or eliminate compliance deviations and non-compliance risks.
Non-compliance to statutory regulations is a risk to several global organizations worldwide and in remote areas. This has posed a great problem to these organizations during production especially in life sciences and also affects the reputation of these brands in essence.
However, AmpleLogic Compliance Software Solution was developed to solve all of these problems and primarily helps in managing all the compliance requirements of any organization. This solution helps in meeting the needs of the organization as regards production, it streamlines manufacturing processes ensuring that they are intact and also helps in reducing errors created by the manual process.
Challenges of Compliance Management in Life Sciences & Pharmaceutical Industries
After a thorough research carried out by our team of experts, we discovered that some of challenges organizations face when using the manual process include:
- Manual process makes it difficult for relevant information related to compliance activities to be documented in registers or logbooks as this process is basically mechanical.
- Compliance status recorded can be too bogus for organization executives to easily peruse through and this includes past compliance status reports.
- With manual compliance management, license details and renewed due dates can be easily forgotten as there are no alerts or notifications.
- License details are not easily spotted in reports and hence, it is difficult to ascertain if they fall short of regulatory standards and acts.
- It may involve the compilation of hundreds of excel spreadsheets in order to support compliance management. This is extremely time-consuming and easily prone to unnecessary errors.
- The legacy systems or traditional tools used in the manual process may not be designed to meet necessary requirements
Features of AmpleLogic Pharmaceutical Compliance Software System
- Compliance Management Software is uniquely designed with a built-in flexible business workflow processes which are quite technical. Predefined processes have also been incorporated in to the software so that customers can easily customize them in order to create a completely unique workflow based on what their businesses require.
- Compliance Solutions is compliant with 21 CFR Part 11. Hence, it meets and satisfies regulatory standards.
- AmpleLogic Compliance Software solution is easily accessible and useable with good user security. This solution provides essential features such as electronic signatures, audit trails, multi-password protections, and user time-stamped activity, etc.
- It has a feature that allows the system to be operated in the user’s local language preventing language barrier and enhancing translation.
- AmpleLogic System comes with Interactive dashboards. This is vital in compliance management because reports are provided with live visibility to all departments in the organization.
- Tasks, triggers, and notifications are automatically generated to specific users when these tasks must be performed. These notifications can also be set for status updates, requests, issues, complaints, assignment and more.
- The system safeguards the integrity of compliance data or information. It also monitors the changes made to all the records in the system.
- Compliance Management Solution helps to create customized reports and automatically generate the compliance reports that are required for the audits of these reports.
AmpleLogic 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