FDA Audit

Passing FDA audits and inspections requires continuous action and preparation on the part of every FDA-regulated company. Audit preparation simply doesn't happen overnight or within a few days/weeks. Solid audit preparation happens when audits are prepared for automatically every day and every hour.

MasterControl, Inc. helps FDA-regulated companies electronically control and streamline all quality related documentation and audit management processes. MasterControl's QMS software was in fact recently selected by the FDA as their QMS of choice and will therefore be the software that FDA auditors are familiar with. Why shouldn't your company benefit from the same solutions?

Select the type of audits that apply to you:

GLP Audits, GCP Audits, PV Audits, Vendor Audits, Supplier Audits

General Quality Audits, ISO Audits, GMP Audits

View Videos

Actelion Pharmaceuticals (3:04)

Passing Audits and Inspections with MasterControl (3:08)

How MasterControl Makes Your Job Easier (3:50)

Free Downloads
	White Paper: Quality Audit - A Tool for Continuous Improvement and Compliance
	White Paper: The Top 5 Benefits of Electronic GLP Audit Management
	Webinar: Automating Quality Audits for Regulatory Compliance
	Interactive and Live Demonstration: MasterControl Quality Suite Demonstration

MasterControl Audit Control

Whether you're looking for a solution that automates the audit management and preparation process for GLP, GCP, PV, Vendor, Supplier, General Quality, ISO or GMP audits, MasterControl has the out-of-the-box solution for your audit control needs. MasterControl has the solutions that are equipped to handle the needs of small companies or large enterprises including Tier 1 pharmaceutical or medical device companies.

MasterControl QAAD for Large Organizations

For large organizations, MasterControl provides MasterControl QAAD, the audit software solution that will prepare any large company for an FDA audit by providing the following:

Centralizes all audit information;
Allows users to communicate across departments regarding quality issues;
Allows users to define unlimited business areas;
Advanced CAPA functionality;
Allows auditors to manage QC, QA or QM activities;
Allows users to standardize risk assessments
Allows users to standardize categories, judgments, CAPAs, findings, memos, activity workflows, root causes and document templates;
Automates, reporting, report responses, email messages/notifications, system messages and the prioritization of audit findings;
Tracks CAPAs;
Simplifies follow-up activities;
Allows users to query for audit data including site, supplier, company or employee data;
Automates the control of external and internal audits

MasterControl Audit for Small Organizations

Smaller companies may want to consider the MasterControl QAAD solution (described above) but some companies may prefer the MasterControl Audit solution. MasterControl Audit is designed to meet the basic audit prepardness requirements for small to large sized companies that are regulated by the FDA. MasterControl Audit centralizes audit information (it's a web-based solution) and automates the scheduling of reoccurring audit activities. The solution also tracks audits and provides reporting capabilities for organized and quickly presentable audit reports. The solution also provides automated task assignment and automated follow-up.

Learn More

To learn more about preparing for FDA audits with MasterControlâ€™s automated audit solutions, please feel free to contact a MasterControl representative.