Research and Development Audit Software

Master schedule

Process-based inspections

Multi-site capabilities

QA statements

Audit certificates

21 CFR Part 11 compliance

Batch release

Life Sciences-specific Features

MasterControl is a demonstrated leading global provider of research and development software solutions for quality groups doing business in highly regulated industries. More than half of the top 20 pharmaceutical companies' audit groups rely on MasterControl research and development software for quality management within R&D groups.

Simplification through Automation

The MasterControl 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 as due dates approach.

Consolidated

MasterControl R&D software unites all quality programs into a single all-inclusive system. As such, all support and validation efforts can be shared across the organization. The solution provides maximum flexibility without the need for external consultants, vendor intervention, or additional programming support. The standard off-the-shelf MasterControl research and development software offering includes all the tools necessary to hit the ground running. Users simply decide which features to use when they are needed without being required to purchase costly add-on options.

Cost effective

MasterControl's software is intuitive and cuts training time, which brings a rapid return on investment at a low total cost of ownership. The scheduling and planning tools are also vital to maximizing resources.

Compliant

MasterControl's R&D system is fully compliant with FDA 21 CFR Part 11. Specific functionalities related to GLP, GCP, and GMP are included within the standard off-the-shelf product. The comprehensive software is based on a flexible access security model, and provides crucial compliance-oriented features such as audit trails and electronic signatures.

Flexible

MasterControl  audit management software has core business processes available "out of the box" and predefined built-in workflows that users can either utilize or customize to create a completely new workflow. This means that the system can easily be modified to conform to corporate policies and procedures without relying on external consultants. The long term effect is a reduced overall cost of ownership.

Electronic Tracking and Distribution

MasterControl's paperless research and development software system incorporates full electronic activity recording and distribution features, including response receipt and CAPA tracking.

Effective Reporting Tools

MasterControl software comes with data trending, metrics, and compliance surveillance tools that allow users to carefully monitor quality and compliance statuses. The holistic software solution incorporates trending/metrics data, risk assessment, and root cause analyses to increase the general effectiveness of quality and compliance surveillance. Numerous standard reports, as well as an ad-hoc query tool, provide comprehensive compliance analysis, CAPA conditions, and the statuses of various studies, projects, and activities.

Language Translation Tools

The system's multi-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 R&D audit software, thereby reducing the time actually required to implement the system.

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