QMS Audit Software Solutions

No more transferring of notes and observations manually. Automated audit processes ensure that all QMS audit-related tasks are complete and on time. From planning and scheduling, through observations, to closure.

The cost and complexities of QMS audit software systems are major obstacles that keep quality organizations tied to paper – until now. MasterControl’s auditing software solution allows quality organizations to connect auditing with other quality processes, including corrective action/preventive action (CAPA), risk management, and supplier management. Stakeholders, auditors, and inspectors can all find the documents they need in one centralized repository.

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MasterControl Audit

Frequently Asked Questions About QMS Audits

What is a QMS audit?

MasterControl’s QMS audit software for life sciences

A quality management system (QMS) audit entails reviewing your quality management system to identify potential flaws and new opportunities to improve and optimize your system. This generally involves evaluating your processes, product inputs and outputs, as well as partnerships, including suppliers.

Audits may recur on a regular basis and attempt to review your system from the top down. Or they may be targeted to address singular occurrences and particular areas of your system.

What are 3 types of quality audits?

There are three main types of QMS audits.

Internal. This type of audit is performed by quality organizations to evaluate their own adherence to current good manufacturing practices (CGMPs).

External. This type of audit is performed by a third-party inspector. It focuses on regulatory compliance.

Supplier. Quality organizations perform these audits to evaluate potential or present suppliers.

How do I prepare for a QMS audit?

The purpose of the QMS audit will dictate the approach that you take to prepare for and/or complete it. It may recur on a regular basis as you review your quality management system from the top down. Or it may be targeted to address a singular occurrence of particular area of your system.

Prepare in three simple steps:

Address past problems.

Be familiar with current regulations.

Review common citations.

Free QMS Audit Resources

Select all the QMS audit resources you’re interested in downloading.

Data Sheet: MasterControl Audit
Industry Brief: Quality Audit - A Tool for Continuous Improvement and Compliance Industry Brief: Compliance Audits: 4 Solutions to Avoid Failure

MasterControl QMS Audit Software

Learn how MasterControl integrates QMS audit process with CAPA, risk management, supplier management, etc. to facilitate compliance and collaboration among stakeholders

Streamline Audit Planning and Scheduling.

Don’t risk missing essential audits, steps, or findings. Our automated QMS audit software sets the first steps in motion for you.
Use Pre-Configured Audit Templates.

You can go into your audits fully prepared with pre-configured checklists and upload your observations ASAP.
Start With Compliance Built In.

MasterControl quality management systems are specifically designed to facilitate compliance for life sciences and other regulated industries beholden to CGMPs.
Take the Paper Out of Document Management.

MasterControl continues to master electronic records and the e-signatures that are so essential to modern compliance.
Accelerate and Simplify Validation.

Cut down validation time from months to hours. Leverage MasterControl validation tools to focus on critical processes.