CAPA Mfg Tool app is a mobile application which will turn devices into data collecting instruments to be utilized regularly in the pharmaceutical laboratory and/or manufacturing facilities. It will collect factual information that is indispensable towards achieving superior pharmaceutical manufacturing investigations, and all at the fingertips of customers. It will also act as a mobile teaching platform that will serve as guide and as a rapid source of information for college students, educators, professionals and individuals looking to enter and advance in the regulated pharmaceutical industries, meeting current Good Manufacturing Practices (cGMP) and federal regulations for any unexplained discrepancy in the manufacturing of drug product (21CFR211 and 21CFR820).
The mobile app was developed as a user-friendly data collection and management system with dynamic graphical data entry interfaces. The user can easily create an investigation’s outline by simply completing the questions found in the investigation sections and attach photos taken using the device. Each section of the investigation consists of a compilation of striking Yes/ No questions required for the data collection of a robust cGMP investigation. The questions were created based on the owner’s expertise and knowledge in the quality and manufacturing areas of the pharmaceutical industries. Based on the user’s response, the mobile app will record the information selected and provide recommendations for additional data to be collected and required to continue the investigation process. The mobile app will allow the user to export the gathered information and recommendations.