Preface
The main body of data reliability assurance and implementation is human. It is obvious that it is meaningless to talk about the data reliability of drug life cycle without human activities. Because no matter electronic data or paper data are used in any link of GXP activities in the life cycle, human intervention or intervention is indispensable (such as collection, recording, processing, audit, decision-making, archiving, destruction, etc.). To explore the factors that influence the reliability of data, the following two aspects should be considered first:
Basic integrity and accomplishment
The lack of personal integrity will lead to cheating or fraud, which will eventually lead to data authenticity problems. This kind of situation will directly distort the truth of the original facts, thus leading to wrong decision-making and judgment (such as selecting good results through repeated tests, recording the unqualified data to the qualified range artificially, destroying or deleting the original electronic data or metadata to avoid inspection), leading to product quality or patient safety related risks. This intentional act is abominable, and it is also abhorrent and severely dealt with by regulatory agencies. As for the factors of fraud, the following is the famous fraud triangle model, which is applicable to all personnel, no matter the senior management, middle management or grass-roots employees.
Management and technical ability to adapt to post responsibilities
From the perspective of job responsibilities, the requirements of data reliability are generally divided into three levels: senior managers, middle managers and general employees. As one of the roles of suppliers, we will not explain it here. It has been described in the second quality management system of this series as data entrustment and outsourcing management.
Top management the top management of an enterprise shall be responsible for establishing a good corporate quality culture and allocating sufficient human and technical resources to ensure that the quality system meets the objective requirements for the reliability of product life cycle data and is ultimately responsible for the reliability of drug data within the organization. The top management of an enterprise should create a working environment that encourages employees to actively communicate failures and errors, including data reliability issues, so that corrective and preventive measures can be taken, and the quality of the organization's products and services can be improved. This includes ensuring that there is sufficient flow of information between employees at all levels. Any management practices that may prevent active and complete reporting of deviations, errors, omissions, and abnormal results, such as hierarchical constraints and a culture of blame, should be actively discouraged.
Middle management Management personnel at all levels shall establish and maintain a quality management system and relevant management procedures with data reliability as the key element; ensure that the work quality of employees related to data reliability is not affected by commercial, political, financial and other organizational pressures or motivations; actively participate in and promote activities to reduce data reliability risks in terms of process, method, environment, personnel, technology, etc 。 It is important to note that the WHO Di guidelines have more stringent requirements for middle management: "key personnel, including managers, supervisors and quality department personnel, shall be trained in measures to prevent and detect data problems. This may require specialized training in evaluation, auditing of electronic data and metadata (such as audit trails) set for the configuration of a single computerized system. ". At present, the current situation of the industry is that many supervisory roles such as middle management or QA it are not trained or do not have the data reliability knowledge suitable for their job responsibilities (for example, when asked about data backup in a pharmaceutical factory, it is found that the system administrator has not visited the system for a year and a half, because he does not know the system and is afraid to log in to the system).
All employees shall comply with the requirements of data management specifications and relevant internal management regulations of the company, and shall be responsible for reporting any problem of data reliability; all staff involved in GXP data shall complete data reliability training and agree to abide by relevant policies and management systems.
