MasterControl's compliance audit software systems are an indispensable tool for handling internal or external regulatory audits of quality processes. Utilizing MasterControl regulatory audit systems for such inspections will aid companies in determining outstanding actions as well as enable them to rapidly identify and better respond to all aspects of a regulatory authority's inspection focus.
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The MasterControl compliance audit software system can be deployed to meet local or global regulatory compliance requirements, and has been specifically developed to help clients:
MasterControl's compliance audit software system makes it possible for detailed inspection plans to be shared with appropriate authorized parties. Emails remind users and/or auditees of planned, current, and outstanding activities. The compliance system's unique scoring concept helps quality auditors assign numeric ratings based on assessments of the criticality, frequency, and impact of a finding.
The compliance system available from MasterControl includes specific features relating to quality inspections and provides users with options to:
MasterControl's compliance audit software system 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, we understand your business needs. 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's compliance audit software can be deployed as a local or global solution to meet all your quality audit needs. MasterControl provides a centralized database that can be used in one or more areas with as much or as little sharing of workflows and data as the user requires. The compliance software harmonizes processes between and across departments. 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's compliance audit software system meets the specific needs of all quality, audit, research and development groups.
MasterControl gives companies the freedom of automated quality processes, replacing inefficient paper-based or hybrid systems with an electronic compliance system that allows users to:
The MasterControl compliance audit software system'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 as due dates approach.
Numerous standard reports, as well as an ad-hoc query tool, provide compliance trend and metric analyses, CAPA status reports, and the status of studies, projects, and activities. Security features, audit trails, and compliance with U.S. 21 CFR Part 11 are all standard elements of MasterControl's software. Global deployment is simplified by the system's multiple language capabilities, which include single - and multi-byte characters.
Whether you are looking to learn more about compliance audit software system or our other exceptional products and services, MasterControl's team of experts is on hand to answer your questions. To learn more about implementing a software solution, call us toll free at 800-825-9117 or contact MasterControl online.