MasterControl's Compliance Audit Software Systems are designed to Automate and Streamline Regulated Quality & Audit Processes
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.
Meet the Challenges of Regulatory Audit Hurdles with Compliance Audit Software Systems
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:
Manage any quality activity across the GxPs
Meet the challenges of GLP multi-site study requirements
Manage clinical trial site information including IRBs
Provide the electronic GLP master schedule
Handle process-based inspections
Maintain details on approved suppliers/third parties
Perform batch release
Assist qualified persons with their expanding review responsibilities
Issue QA statements and audit certificates
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:
Directly enter and categorize findings
Attach supporting evidence
Perform peer review
Approve reports prior to issue
Issue into a secure web browser or document for direct entry of responses and actions
Analyze root causes
Perform risk assessments
Enter auditor-specific notes
Features and Benefits of MasterControl's Compliance Audit Software System
Proven Solution for Life Sciences Companies: MasterControl is a demonstrated leading provider of compliance audit software solutions for audit
and quality groups in highly regulated industries. More than half of the world's top 20 pharmaceutical companies rely on MasterControl compliance audit software systems for their quality management.
Consolidated: MasterControl's compliance audit software unites all quality programs into a single comprehensive system, enabling validation and support efforts to be shared across the enterprise. The solution provides maximum flexibility without the need for vendor intervention, external consultants, or additional programming. MasterControl's quality compliance system includes all the necessary tools within the standard off-the-shelf product-users can decide which features to use without being required to purchase costly add-on options.
Cost effective: MasterControl is intuitive 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 system's scheduling and planning tools.
Compliant: MasterControl is fully compliant with U.S. 21 CFR Part 11. Specific functionalities related to GLP, GCP, and GMP are included with the standard off-the-shelf product. The comprehensive compliance audit software system is based on a flexible access security model, and provides crucial compliance-oriented features such as audit trails and electronic signatures.
Flexible: MasterControl's compliance audit software has core business processes available "out of the box" and includes predefined workflows that users can either customize or use as is to create a completely new workflow. This means that users can easily update the system to conform with internal procedures without needing assistance from consultants. This contributes to keeping ownership costs 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 compliance audit software systems come complete with data trending, metrics, and compliance surveillance tools to help monitor quality and compliance statuses. The 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 compliance audit software 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 the software.
More about MasterControl Compliance Audit Software System
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:
Create quality and compliance plans
Manage resources and projects
Write quality and compliance findings directly into the database
Perform peer review / approval prior to issuing reports
Electronically issue results to a document or web browser
Remotely record findings
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.
Contact Us About Our Compliance Audit Software Systems
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.
MasterControl Inc. and its partner, i4DM, are expanding their FDA project, serving as the QMS providers for a second FDA division. The two companies have been the QMS providers for the FDA's Office of Regulatory Affairs since 2009. Now they will also serve as quality providers for the Division of Pharmaceutical Analysis, which is part of the FDA's Center for Drug Evaluation and Research.