Case Study: Validating Mi-Co e-Forms System

Introduction

Mi-Co, the mobile data capture software company, needed assistance with validation of its flagship Mi-Forms e-forms system. Ofni Systems was recommended to Mi-Co due to the complexity of the system and the need to complete the project expeditiously. The Mi-Forms system is a proprietary system, combining ASP.Net web-based pages with local executable files. Communication between system components follows a client-server model. In particular, Mi-Co was concerned that its products meet 21 CFR Part 11 requirements regarding electronic records and electronic signatures. The company also needed to test e-forms throughout a combination of inputs and operational platforms.

Validation Process

The Mi-Forms system is a combination of several programs. Mi-Co was principally concerned with validating the Mi-Forms Server software, Mi-Forms Client software, and the digital pens used for input. The first step in the validation process was to gather system requirements. Through discussion with Mi-Co developers and careful examination of Mi-Co documentation, Ofni Systems created functional requirements for validating the Mi-Forms software. These requirements were further detailed in the design specification.

Prior to validation testing, Mi-Co assisted Ofni Systems in creating numerous testing environments. The Mi-Co Client software was tested on both the Microsoft XP and Vista operating systems. Mi-Forms were tested on paper, tablet PCs, and within the Mi-Forms client. The Mi-Forms system used two different digital input pens. Ofni Systems tested each digital pen with each operating system. Digital pens were tested by entering data onto paper forms, then synching the digital pens with the Mi-Forms system. Electronic forms were also tested by entering information through tablet PCs and the Mi-Forms client. Numerous types of data entry were tested, including handwriting recognition. The Mi-Forms system was fully tested and demonstrated that it met all established requirements.

Ofni Systems then tested the Mi-Forms system for compliance with 21 CFR Part 11. This included examining Mi-Forms compliance with accurate record generation, program timeout, audit trails, event logging, input checks, and password controls. Ofni Systems created protocols to test compliance for each element. The Mi-Forms system was tested, demonstrating that it was compliant with all aspects of 21 CFR Part 11.

Another important aspect of the Mi-Forms system requiring testing was forms events. Twelve specific forms events, affecting forms, fields, and pages were tested. Ofni Systems wrote test cases for each event. Each form event was tested on both Microsoft XP and Vista operating systems. All twelve events were successfully tested in both operating environments.

Conclusion

Ofni System’s validation of the Mi-Forms system allowed Mi-Co to quickly and efficiently demonstrate compliance with 21 CFR Part 11 regulations. After the validation process was complete, the validation results were reviewed and approved by a third party auditor. Ofni Systems and Mi-Co have established an agreement to continue auditing future versions of the Mi-Forms e-forms system.

About Mi-Co

Mi-Co, the mobile data capture company, provides digital writing software to increase the efficiency and effectiveness of the entire process of capturing and using data. Mi-Co’s end-to-end enterprise Mi-Forms Software System enables flexible forms design and the capture, handwriting verification, and communication of forms based data for enterprise users. Mi-Forms supports enterprise data capture using the Tablet PC, the Logitech IO Digital Pen, Pocket PC, and signature capture devices. Mi-Co is headquartered in Research Triangle Park, North Carolina.

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 their 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 www.OfniSystems.com.