MaxisIT® is strictly committed to the highest quality that shows repetitive results and security of the client data and other data; this is ensured by following the procedures which are internationally accepted and approved as the best quality standards.
MaxisIT® is compliant with regulatory expectations for software developers and service providers within the global regulatory environment. MaxisIT® demonstrates compliance with Good Clinical Practice (GCP), regulations including US FDA 21 CFR parts 11, 312 and 812, the EU Commission Directive 2005/28/EC and ICH E6. In so doing, MaxisIT® can also demonstrate compliance with the ICH E6 sections on data handling and record keeping. Further, MaxisIT® products and services are flexible and can be configured to aid and support our clients with their overall GCP compliance.
Moreover, as a Software as a Service (SaaS) provider, MaxisIT® adheres to the data protection expectations as per ISO standards.
In addition, MaxisIT® products specifically support appropriate compliance with Electronic Records and Electronic Signature (ERES) requirements including the US FDA 21 CFR part 11 and Japan's Ministry of Health Labor and Welfare (MHLW) ERES Regulation. We provide further support to assist our clients with their ERES compliance by training users on the significance of electronic signatures and requiring documentation of such training prior to end users utilizing MaxisIT® products.
MaxisIT® has the following Quality Standards in Compliance at its software development and delivery center based in India:
MaxisIT® ensures that all the standards listed are perfectly maintained through regular audit checks internally as well as externally to identify the required adjustments from time to time. At MaxisIT® the procedures for quality are enhanced continuously for better performance there by eliminating the need for rework. MaxisIT® uses the software development methodologies and frameworks in compliance with the quality standards to reduce the scope of failure and to have a timely successful completion of deliverables.
MaxisIT's Quality Management System incorporates policies and procedures covering, but not limited to, such areas as Management Responsibility, Internal Audits, Corrective/Preventive Action, Records Retention, Control of Quality System Records and Client Complaints.
All MaxisIT® products are designed, built, validated and deployed using a standardized MaxisIT® Software Development Life Cycle. Product releases have documented requirements and design specifications and validation plans, along with a full suite of functional, operational, and performance tests. Each product release yields a Validation Certificate that includes a list of all documents that support the validated status of the product, plus release notes and impact statements.
Quality at MaxisIT's Core Value addition to the Project Lifecycle Management
Quality Management is a pragmatic approach that is changing the way organizations think about project lifecycle management by enabling them to proactively address quality from the very beginning of the project delivery lifecycle.
Quality Management aligns business priorities and quality expectations with project requirements, development activities and software testing with a comprehensive solution for software quality assurance, management and control.
Quality itself is often hard to define because it means different things to different people, but in the context of software quality assurance, the simple and appropriate definition of software quality is the convergence of complete requirements, correct code, and minimal defects that align to meet business goals.
MaxisIT's Quality & Regulatory Affairs team is involved in all aspects of MaxisIT's product and services business. Additionally, performs:
Event Date: December 8, 2013 Metuchen High School, NJ