QMS Software Reflects GMP Standards
Over the years consumer safety problems served as a catalyst for change in industry regulation. For example, 107 people in the United States died in 1937 due to the antibacterial drug Elixir Sulfanilamide, forcing authorities worldwide to establish Good Manufacturing Practice (GMP) standards. QMS systems using QMS software are designed to implement GMP standards.
In the U.S., the Food and Drug Administration (FDA) enforces regulations for pharmaceutical, medical device, blood and biologics, and other regulated industries. The agency also provides guidances that offer a framework for establishing QMS systems.
In other parts of the world, there are similar regulations and standards that are driving the increasing use of QMS software. They include MHRA, EMA, and MHLW rules; EU Annex 11 and ICH guidelines; and ISO and EU GMP standards.
QMS Software and FDA Compliance
Of all the regulations that the FDA enforces, the two below are among the most important and the most widely applied worldwide. QMS software for life science companies are designed based on requirements that can be found in these regulations:
- 21 CFR Parts 210-211: This is the primary regulation that pharmaceutical companies must comply with. It covers every aspect of drug development and manufacturing, including the creation and maintenance of a QMS system.
- 21 CFR Part 820 (Quality System Regulation or QSR): This is the primary regulation for medical device companies. Similarly, it requires device manufacturers to establish controls in design, document, manufacturing, and production processes, as well as maintain a QMS system.
In addition to regulations that the FDA enforces, the agency encourages manufacturers to adhere to standards and guidelines that are deemed complementary. Robust QMS software usually address these standards in addition to FDA regulations:
- 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.
How MasterControl QMS Software Can Help You
FDA, ISO, EU directives, and other regulatory requirements require the establishment of a QMS system. MasterControl quality and compliance software provides an effective framework for a company’s QMS system by automating all documents- and forms-based processes, connecting all quality processes, and providing a centralized location for all documents.
Mobile Access: MasterControl offers a distinct advantage by providing mobile access, allowing users to access information and perform tasks using a tablet or a smartphone. Mobile access will offer greater flexibility for users and help boost overall efficiency and productivity.
Cloud-Based Services: Buying QMS software doesn’t have to be prohibitive. For companies concerned about the high cost of owning a QMS system, MasterControl offers cloud-based services. A cloud-based QMS system offers the same robust system in a secure environment without the need for a huge, up-front cost of, or a large IT staff.
MasterControl QMS software offers the following modules:
- 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.
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