2013 PDA/FDA Joint Regulatory Conference

Tyson Mew, president of Ofni Systems, will be at the 2013 PDA/FDA Joint Regulatory Conference in Washington DC on September 16-18, 2013. Ty will be demonstrating FastVal, Ofni Systems’ validation management system that provides validation managers with the unique ability to control their validation process. Using FastVal allows your validation engineers to do more testing while reducing the time required to complete a validation project by up to 70%. Ty will also be demonstrating ExcelSafe, which provides MS Excel spreadsheets with audit trails, individual user passwords and all of the technological controls required for compliance with 21 CFR 11 and other FDA regulations for electronic records and signatures.

The PDA/FDA Joint Regulatory Conference will provide FDA representatives and industry experts a forem to meet and discuss critical pharaceutical industry issues such as continual process validation, supplier management and quality oversite, supply chain and drug shortages and effective management of post inspection follow-ups. Parenteral Drug Association (PDA) is a global provider of science, technology and regulatory information and education for the pharmaceutical and biopharmaceutical community.

Ty Mew and Ofni Systems will be available throughout the conference to discuss validation management, spreadsheet compliance and accept resumes from validation professionals.

Registration information for the 2013 PDA/FDA Joint Regulatory Conference is available.

FDA Laboratory Information Bulletin 4524

FDA Laboratory Information Bulletin 4524

The FDA publishes an internal Laboratory Investigation Bulletin (LIB) each month that is distributed to all FDA employees. It contains articles written by FDA employees that describe methods, procedures and products that a site has used that have demonstrated a high degree of success or an improvement over an existing method. The goal of these articles is to promote best practices to other sites within the agency. In the June 2012 issue, the San Juan District Laboratory released a Laboratory Information Bulletin 4524 detailing their experiences with ExcelSafe.

The San Juan District Laboratory investigation showed that ExcelSafe improved the analytical spreadsheet’s application’s data integrity, security and template accountability by using electronic signatures, audit trails, and other compliance and tracking features. Using ExcelSafe improved laboratory efficiency by decreasing the time required for internal document review. They praised the ease of using ExcelSafe, noting that ExcelSafe had produced significant cost and time savings, and stated they would continue to use ExcelSafe.

Download a copy of Laboratory Information Bulletin 4524 “Evaluation of ExcelSafe to Implement Part 11 Rules in FDA Analyst WorkBook Files”

FDA Releases Laboratory Investigation Bulletin Discussing their Use of ExcelSafe

MS Excel is the FDA’s software of choice for processing results, analyzing and presenting scientific data in their chemical and microbiological laboratories. The FDA, like many organizations, uses Excel to record test results and other report data, and needs compliant, password protected spreadsheets. The San Juan District Laboratory wanted to retain the power and flexibility of Excel for their analysts, while transitioning to a paperless environment and remaining compliant with 21 CFR 11. In order to achieve these goals, the San Juan District Laboratory selected ExcelSafe by Ofni Systems.

The FDA publishes an internal Laboratory Investigation Bulletin (LIB) each month that is distributed to all FDA employees. It contains articles written by FDA employees that describe methods, procedures and products that a site has used that have demonstrated a high degree of success or an improvement over an existing method. The goal of these articles is to promote best practices to other sites within the agency. In the June 2012 issue, the San Juan District Laboratory released a Laboratory Information Bulletin 4524 “Evaluation of ExcelSafe to Implement Part 11 Rules in FDA Analyst WorkBook Files” detailing their experiences with ExcelSafe.

Click Here To Download
The San Juan District Laboratory investigation showed that ExcelSafe improved the analytical spreadsheet’s application’s data integrity, security and template accountability by using electronic signatures, audit trails, and other compliance and tracking features. Using ExcelSafe improved laboratory efficiency by decreasing the time required for internal document review. They praised the ease of using ExcelSafe, noting that ExcelSafe had produced significant cost and time savings, and stated they would continue to use ExcelSafe.
Learn more about ExcelSafe

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

About Ofni Systems
Ofni Systems is an industry leader for 21 CFR Part 11/Annex 11 compliance and automating the validation process. Started in 1999, their products for compliant databases and spreadsheets are used by the FDA, pharmaceutical, biotech and medical device companies across the globe. They are the creators of ExcelSafe for Excel spreadsheet security and the Part 11 Toolkit for compliant databases. They also are the creators of the FastVal validation software for generating and executing validation documents, and have been providing professional validation services using FastVal since 2006. The company’s products for computer validation, auditing and FDA submissions ensure that their clients meet all requirements for electronic records and electronic signatures. Ofni Systems provides live desktop support for superior customer support and training. For more information, call (919) 844-2494 or visit www.OfniSystems.com.

Ofni Systems to Exhibit at PDA FDA 2012 Conference: Redefining the C in CGMP Press Release

Tyson Mew, president of Ofni Systems will be at the 2012 PDA FDA Joint Regulatory Conference in Baltimore, MD on September 10-12. The PDA FDA conference has the title “Compliance through Quality Systems: Implementing & Advancing a Sustainable Global Quality Culture”. In joint collaboration with the FDA, PDA has designed the conference to reflect how a robust quality system can enhance business goals and objectives. The conference will feature a series of regulatory and industry leaders in quality and compliance.

Registration information for PDA FDA Joint Regulatory conference is available.Ty Mew and Ofni Systems will be available throughout the conference to discuss software compliance, demonstrate their validation automation tools and accept resumes from validation professionals.

About Ofni Systems
Ofni Systems is an industry leader for 21 CFR Part 11/Annex 11 compliance and automating the validation process. Started in 1999, their products for compliant databases and spreadsheets are used by the FDA, pharmaceutical, biotech and medical device companies across the globe. They are the creators of ExcelSafe for Excel spreadsheet security and the Part 11 Toolkit for compliant databases. They also are the creators of the FastVal validation software for generating and executing validation documents, and have been providing professional validation services using FastVal since 2006. The company’s products for computer validation, auditing and FDA submissions ensure that their clients meet all requirements for electronic records and electronic signatures. Ofni Systems provides live desktop support for superior customer support and training. For more information, call (919) 844-2494 or visit www.OfniSystems.com.

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

CDR Increasing Emphasizing on 21 CFR 11

IVT Validation Week at the DoubleTree Hotel

FDA Validation Inspections and Latest Trends – FDA Validation Inspections and Latest Trends – The presentation will discuss FDA audit observations relating to validation. In particular, the presentation will examine why validation is consistently one of the most common observations reported in FDA audits and which types of validations generate warning letters. In particular, the presentation will focus on Computer System Validation, Equipment Validation and Cleaning Validation.

Computer System Remediation & Validation for Regulatory Inspection – A Case Study – This presentation will outline a computer software validation compliance program. In particular, the presentation will demonstrate methods to generate validation documentation, and provide validation solutions for commonly used software like MS Access and MS Excel. The presentation will also include a validation case study review.

Philadelphia, PA