An Ergonomic Perspective of Software Validation in the Medical Product Manufacturing

Introduction

This chapter presents the eDHR Computerized System Validation Process (eDHR) in direct relation to the intended use of said software. This consists of electronically recording the history of medical devices that are manufactured in a company located in Tijuana. This work is referenced in the fifth version of the Good Automated Manufacturing Practice Guide 5 (GAMP5) of the International Society of Pharmaceutical Engineering (ISPE). This guide contains the implicit risk-based approach to the quality and labeling of medical devices. In addition, it is based on the regulations that companies regulated by the Food and Drug Administration (FDA) must abide by.

This is because the validation of computerized systems is of great importance in companies that manufacture medical products. This importance is due to the contribution in the FDA regulation on quality system management (standard 21CFR820), on electronic records and electronic signatures (standard 21CFR11) and on the minimum requirements of Good Manufacturing Practices Updated to manufacturing, processing, packaging or retention of finished drugs and pharmaceuticals (standard 21CFR210 / 211). Also, this is because it implies the assurance, with objective and documented evidence, the performance of its usual operation and that it would be reproducible, complying with the requirements set by its user.

The present proposal is to validate the progress on the productive floor of eDHR through the GAMP5 guide. Whose approach based on latent risk against the quality and labeling of medical devices is practical to ensure compliance with the FDA and its intended use. This objective can be solved in four phases which consists of organizing and integrating the project resources into a work plan, specifying the requirements that satisfy the user's need, verifying compliance with the requirements set forth by the user and therefore completing the validation.

Therefore, this effort is based on two main axes: one that adheres to legal compliance and the second to its intended use. The aforementioned elements, in duality, consolidate confidence in the performance of eDHR. Hence, to limit its scope, this project does not deal with software validation since it is the responsibility of the study in the computer science area. This is in itself, the validation of the union between a computer system and an operational process that is presented within the context in which the project is carried out.

This addresses the basic points that create the context where the validation activities take place. For this reason, it has resolved nonconformities that the manual procedure of the Device History Record (DHR) presents during its performance. Paper and ink are the means that the user previously used to capture data in the route, parameter and acceptance records that make up the DHR process. Following this, these paper records were sorted and piled up in packages averaging eighty sheets each. And therefore, the packages are packed in boxes controlled by an internal warehouse and an external one.

DHR's manual procedure helped to separate delicate and difficult-to-mitigate failures at the hands of the customer, affecting the credibility of quality in business operations. This had five origins. The first was due to the fact that manual method activities evidenced out-of-parameter data, expired calibration dates, rejected quality tests, and exposure to signature corruption. The second origin was due to the human factor that showed the omission of data, incorrect data, and captures in the wrong fields. The third origin was due to the environment where lost and/or misplaced documents have been found. The fourth was due to the material used and in which an excess of sheets of paper has been observed, together with the abuse during its handling. The last origin was due to the printing machine of which it was observed blurred or with excessive ink, incomplete, and with printing errors.