Ofni Systems releases GxP Auditor to manage GxP Compliance Audits

RALEIGH NORTH CAROLINA – Monday, June 22, 2008 – Ofni Systems has released GxP Auditor, which facilitates and tracks the entire compliance audit process, from the initial letter to final closure. “GxP Auditor allows auditees to control the audit process, managing auditor requests, tracking observations and producing official responses,” said Ofni Systems President Tyson Mew.

GxP Auditor manages the GxP Audit:

• Track Auditor Requests and Schedule Presenters – Auditor requests are entered directly into GxP Auditor. Audit staff sees the requests automatically and can prioritize actions appropriately.
• Records Documents – GxP Auditor retains a complete list of all documents requested by auditors, including which documents auditors retained a copy.
• Facilitates Audit Team Communication – Auditor requests are entered in the Audit Room, and viewed in live-time in the Audit Preparation Room.

After the compliance audit, GxP Auditor:

• Track Audit Observations – Audit Observations can be prioritized, updated and organized.
• Track Corrective Actions and Audit Responses – GxP Auditor manages your responses to audit observations, allowing you to determine who in your organization is responsible for each corrective action and track completion for each item.

GxP Auditor has full reporting capabilities, including reports for auditor requests, inspection readiness actions, audit observations and observation responses. GxP Auditor features a user-friendly interface and is fully compliant with 21 CFR 11.

About Ofni Systems
Ofni Systems is an industry leader for 21 CFR Part 11 compliance. Their products for Part 11 compliant databases and spreadsheets are used by pharmaceutical, biotech and medical device companies across the globe, while it’s products for computer validation, auditing and FDA submissions ensure that their clients meet every requirement for electronic records and electronic signatures. The company provides live desktop support for superior customer support and training, and has been providing solutions to their clients since 1999. For more information, call (919) 844-2494 or visit http://www.OfniSystems.com.

Media Contact
Tyson Mew
President
Ofni Systems, Inc.
Phone: (919) 844 2494