As Technical Project Leader for a major pharmaceutical company, I was tasked with assessing uncontrolled MS Access database’s and developing a compliant and secure solution. The project involved multiple databases with repetitive tasks and lacked connectivity. After assessing the common features, I combined them according to relational database guidelines, designed and performed user acceptance testing, and performed a risk assessment and qualification for use in the lab.

To improve compliance in the quality control laboratory, I used the Split Database Architecture, which involved dividing the database into a front-end and a back-end. The front-end contained forms, queries, and reports, while the back-end contained tables. I distributed the front-end to each user, while the back-end was stored on a network share. This prevented users from modifying tables directly and reduced the risk of data corruption.

To prevent data breaches and unauthorized access, I created unique user accounts with passwords and configured user groups based on the level of access needed. This simplified management of access rights and administration. I also encrypted the database to prevent unauthorized access and automated the backup process to prevent data loss.

Finally, I developed usage and administration procedures to ensure that the new database was used in compliance with regulatory requirements.