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industr ies & solu tions
Electronic signature Data integrity regulations from regulatory authorities, such as the FDA, EU or MHRA, require that only authorised individuals are able to change critical process values. The electronic signature (eSig) helps to create a more secure application, especially in a GMP-regulated environment.
I NTRO D U C TI O N TO TH E E LE C TRO N I C S I G N AT U R E According to data integrity guidelines for the pharmaceutical industry, data must meet the Attributable, Legible, Contemporaneous, Original and Accurate principle - ALCOA for short. In the case of an electronic signature, the user needs to ‘sign‘ (by entering their username and password) if they are to make critical changes. In this way, we satisfy the ‘Attributable‘ principle. The change is then permanently stored in an audit trail database with a timestamp (Contemporaneously recorded) and the value information (Original and Accurate). Furthermore, actions can be retrieved for a review by quality assurance (QA) or an inspector (thereby fulfiling the requirement for the information to be Legible). Electronic signatures uniquely identify the user making the change and, as an option, another person may be required to electronically sign to verify the change. An application within a GMP-regulated environment typically contains critical parameters. They are called
critical process parameters (CPP) or GMP-relevant parameters. To translate this into the language that zenon speaks: they are select process variables. A critical parameter is, by definition, a variable that can have direct impact on a patient’s health. A two-step signature can also be enforced. In such a use case, if an operator wants to change a CPP, the system will notify them that a user with supervisory status is required to perform the change. Additionally, a third user with QA status may be required to verify the change. In such an example, all users would need to type in their user credentials and add a comment. An electronic record of each of the steps is created in the audit trail. This means that operating personnel no longer need to use pen and paper to record and sign for their actions. Using electronic signing, the potential to lose or damage such paper-based records is eliminated. As documentation is a requirement, all user actions are stored in a central database. Using easy filtering mechanisms, a comprehensive audit trail or signature
