GxP Compliance With Quality Tracking Software
Advanced trending tools make it possible for MasterControl quality tracking software users to quickly identify issues that impact quality and cost, and to ensure that appropriate follow-up and actions are taken. Features of the powerful analytics tools include:
- Cross discipline search capabilities
- Search refinement
- Ability to export to Microsoft Excel spreadsheets
- Data analysis for trend and metric reporting
To help companies deal with all types of quality issues, MasterControl quality tracking software incorporates the following regulatory features:
- The GLP module is designed specifically to assist quality groups working under the Good Laboratory Practice (GLP) requirements of OECD, U.S. CFR Title 21, and the U.S. CFR Title 40.
- The GLP module also includes all the functionality necessary to meet OECD requirements for the regulated master schedule, QA statements, and multi-site studies; the module also has a built in study-based, process inspection management tool.
- The GMP module is engineered to assist quality groups working under Good Manufacturing Practices of the U.S. CFR Title 21 and 91/356/EEC.
- The GMP module can also be used for batch release reviews.
- The GCP module can generate a GCP compliance statement.
- The GCP module is designed to assist quality groups working under the Good Clinical Practices requirements of ICH GCP and ICH GCVP.
- All modules (GLP, GCP, and GMP) track the status of internal and external sites, including suppliers and vendors.
Features and Benefits of the MasterControl Quality Tracking Software System
- Life sciences: MasterControl is a demonstrated leading provider of quality tracking software solutions for research and development quality groups in highly regulated industries. More than half of the top 20 pharmaceutical companies in the world rely on MasterControl quality tracking systems for their quality management within research and development groups.
- Consolidated: MasterControl quality tracking software unites all quality programs into a single comprehensive system, enabling validation and support efforts to be shared across an organization. The solution provides maximum flexibility without the need for vendor intervention, external consultants, or additional programming. The MasterControl system includes all the necessary tools within the standard off-the-shelf product - users decide which features they need without being required to purchase costly add-on options.
- Cost effective: MasterControl's software is intuitive, streamlines quality processes, and reduces training time, bringing a rapid return on investment at an amazingly low total cost of ownership. Staff resources are optimized by the MasterControl solution's scheduling and planning tools.
- Compliant: The MasterControl quality tracking system is fully compliant with U.S. 21 CFR Part 11. Specific functionality related to GLP, GCP, and GMP is included with the standard off-the-shelf product. The comprehensive tracking system is based on a flexible access security model and provides crucial compliance-oriented features such as audit trails and electronic signatures.
- Flexible: The MasterControl system has core business processes available "out of the box" and includes predefined workflows that users can either customize or utilize "as is" to create a completely new workflow. This means that users can easily update the system to conform to internal standards and procedures without requiring assistance from outside consultants. This helps keep the total cost of ownership low.
- Electronic Tracking and Distribution: A paperless solution, MasterControl incorporates full electronic activity recording and distribution features, including response receipt and CAPA tracking.
- Robust Reporting Tools: MasterControl quality tracking software comes with data trending, metrics, and compliance surveillance tools to help monitor quality and compliance statuses. The software solution incorporates trending/metrics data, risk assessment and root cause analysis to increase the overall effectiveness of quality and compliance surveillance.
- Language Translation Tools: The system's language capabilities can translate dictionary data and display system field labels in the user's local language (using either single or multi-byte characters).
- Reduced Implementation Time: Business processes are pre-mapped in the standard off-the-shelf product, reducing the time needed to implement and validate the software.
About the MasterControl Quality Tracking Software System
MasterControl's proven quality tracking software solution is a user-configurable, validated, off-the-shelf tool designed and developed by QA, for QA. Whether your company is a small start-up, a division of a larger organization, or a corporate group, MasterControl understands your business. Regardless of the organization's size, users can configure MasterControl's software to effectively manage quality, compliance, and CAPA programs. Versatile tools allow users to manage dictionary terminology, create custom screen labels, configure workflows, and design templates.
If your organization is responsible for GLP, GCP, GMP, environmental audits, vendor management, and/or pharmacovigilance/product safety audits, MasterControl quality tracking software can be deployed as a local or global solution to meet all your company's audit needs. The MasterControl solution provides a centralized database that can be used in one or more areas with as much or as little sharing of workflows and dictionary data as the user requires. The software harmonizes processes between and across audit groups. By having built-in regulatory requirements (i.e., GLP multi-site study capabilities, QA statements, a GLP master schedule, audit certificates, as well as batch release, "qualified person" tools, supplier evaluation, clinical trial monitoring, and key data capture) MasterControl software meets the specific needs of all research and development quality groups.
Numerous standard reports, as well as an ad-hoc query tool, provide compliance trend and metric analyses, CAPA status, and the status of studies, projects, and activities. Security features, audit trails, electronic signatures, and compliance with U.S. 21 CFR Part 11 are all standard features of the solution.
Automating Quality Processes with MasterControl Quality Tracking Software
MasterControl quality tracking software gives companies the freedom of automated processes, replacing inefficient paper-based systems with an electronic system that allows users to:
- Create quality and compliance plans
- Manage resources and projects
- Write quality and compliance findings directly into a centralized database
- Remotely record findings
- Perform peer review/approval prior to issuing reports
- Electronically issue results to a document or web browser
The MasterControl quality tracking software solution's web-based response features allow personnel to electronically receive findings and comments, respond to them, and track the status of individual CAPAs. Workflows can be configured to manage follow-up and implementation status, with email reminders automatically generated by the system as due dates approach.
Contact Us About Quality Tracking Software Systems
Whether you are looking to learn more about quality tracking software systems or our exceptional products and services, MasterControl's team of experts is on hand to answer your questions. To learn more about implementing an audit software solution, call us toll free at 800-825-9117 or contact MasterControl online.