QMS Software

ISO 13485 and ISO 14971: These are voluntary standards that apply to medical device manufacturers. ISO 13485 focuses on the creation and maintenance of a QMS system, while ISO 14971 provides risk management guidelines that apply specifically to medical devices.

ICH Good Clinical Practice: Most pharmaceutical companies and CROs that conduct clinical research also adhere to International Conference for Harmonization’s (ICH) GCP guidelines for designing and conducting clinical trials for new medicines. 

They typically use QMS software specifically designed for the establishment of a clinical quality management system (CQMS) that would help them manage the clinical trial throughout its duration.

MasterControl Documents:

For most companies, this module typically serves as a centerpiece for an effective QMS system that greatly increases efficiency and productivity. It automates tracking, search, retrieval, routing, review, and approval of documents.

MasterControl Process:

Together with MasterControl Documents, this module can serve as the framework for a robust QMS system. It automates any forms-based process, offering best-practice forms that prompt users with selected data to reduce data entry and avoid common data-entry mistakes.

MasterControl CAPA:

This module makes it easy for companies switching from a manual QMS system to an automated system to implement a CAPA system. It offers industry best-practice forms that help reduce error in data entry. It streamlines the CAPA process by giving users the capability to launch a CAPA form another form, such as nonconformance.

MasterControl Training:

Unlike other QMS software, MasterControl Training does more than automate distribution and monitoring of training tasks. It also provides the capability for online grading of tests. It also has the advantage of sequencing training courses, so a trainee who completes a prerequisite course will automatically get the next training.

MasterControl Audit:

This module streamlines the audit process by automating all audit-related tasks and schedules. It provides robust tools for managing and conducting regular audits. MasterControl offers a key advantage over other QMS software with its capability to connect the audit management process with all other critical processes within the QMS system.