Compliance Audit Software Systems

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

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

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.

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