External Audit

External audits are conducted to determine the validity of quality documentation, to verify that quality documentation is accurate and to ensure that documentation corresponds with the regulations and standards that are required within regulated industries.

MasterControl, Inc. provides automated tools that maintain compliance, strictly control and manage documentation and streamline product lifecycle processes so that companies can always be ready for a planned or unplanned external audit.

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

How it Works

At the core of compliance and the successful completion of external audits are well maintained documentation, organized training records (i.e, training records that show proof that document related training is taking place) and the overall successful management of business practices from internal audit planning to customer complaints management and from change control to CAPA.

MasterControl enables the automation of audit preparation by controlling and recording all data for documentation, training, business processes and lifecycle management. For example, when external auditors arrive, they w ill find quick access to documentation, easy-to-follow audit trails (for both documentation and training) and a history of digital signatures that have been recorded in accordance with 21 CFR Part 11 standards. CAPA, change control, customer complaint, previous audit and other industry-specific forms are also electronically available in conjunction with related documentation and/or justification (e.g, for change control or CAPA processes). Analytics and reporting tools are also available and may be valuable during internal or external audit processes.

For More Information

To learn more about MasterControl audit software and additional automation solutions for regulated and standard-adhering industries, please feel free to contact a MasterControl representative.