The pain points faced by GMP training management in enterprises
Complex regulatory requirements
There are many regulations and standards in the pharmaceutical industry, covering a wide range, and the training needs for employees are complex and strict. Therefore, employees need to understand and abide by various GMP standards, including drug production, quality control, equipment cleaning and employee hygiene requirements.
Diversified job requirements
Pharmaceutical enterprises involve various positions and responsibilities, and each position has specific GMP training needs. The content and form of training for different positions need to be tailored, which is difficult to manage and maintain.
Frequent regulatory updates
Drug regulatory authorities frequently update and modify GMP standards and regulations, and enterprises need to understand and adapt to the new requirements in time to ensure that the training content is updated in time and meets the latest regulations.
Complexity of training management
For large pharmaceutical enterprises, there are many employees and jobs. How to manage and supervise the implementation of the training plan and evaluate the training effect is a challenging task.
Tracking and evaluation of training effect
Pharmaceutical enterprises need to track and evaluate the training effect of employees, but the existing tracking and evaluation mechanism may not be perfect enough to objectively evaluate the training effect and the compliance level of employees.
Cindiotai? Quality compliance digital platform
Aotai? IT is a digital platform jointly built by industry experts and IT experts of Singedi. Taking "quality compliance experts" as the management concept and market positioning, we will help enterprises improve their quality compliance level, meet industry supervision, enhance their management capabilities, and speed up the listing of more safe, effective and reliable products. The Training Management System (TMS) was designed by New Dior Tai? One of the core systems on the platform.
Singedi GMP Training Management System (TMS) One-stop Training Solution for Pharmaceutical Enterprises
Xingedi GMP Training Management System (TMS) is based on the pharmaceutical industry, designed by quality management experts in the pharmaceutical industry, and provided with compliance guarantee by Kanglihua Consulting. The product design is in strict accordance with GMP, ICH Q7a, FDA 21CFR Part 1 1, cGMP and EU-GMP (attachment11). Xingedi GMP Training Management System (TMS) fully meets the requirements of industry regulations for training system, including. Supporting diversified training forms can meet the learning needs of different students and enhance the flexibility and convenience of training. At the same time, it supports the real-time tracking of training progress and effect, the management of training records and the automatic statistics of using reports, which is convenient for assessment at any time and improves the transparency and efficiency of management. TMS supports docking with Singedi DMS file system or third-party DMS system, which can automatically generate courses for files that need training, realize the seamless connection between training and file system, and improve the convenience of management.
Highlights of Xingedi GMP Training Management System (TMS)
Training matrix
The training matrix module is mainly used to formulate corresponding on-the-job training tasks for enterprise employees and realize real-time management of training progress, so as to realize closed-loop management of the whole process of training business. Support training needs in different scenarios such as induction training, job transfer training and regular training. Through the matrix, the training administrator can effectively manage the company's compliance training tasks and avoid the wrong delivery of training tasks. At the same time, when the file status changes, such as file upgrade, file freezing and file cancellation, the system can automatically identify and update the matrix.
training plan
The training plan module supports the automatic generation of individual annual/monthly training plans according to the job training matrix. The training plan includes course selection, version management, schedule management, authority allocation and audit trail, matrix view display, automatic task allocation, etc. At the same time, it supports tracking the completion of all planned items in the annual plan, and can conduct annual review and statistics.
Training files
Training files support three forms: individual viewing of employees, viewing of training administrators and providing official inspection requirements. You can clearly list the training task list, completion rate, specific examination results, qualification certificate (including the validity period of the certificate) and other information by year, month and day. Support the establishment of file standard template management, and support the manual uploading of basic information of existing personnel to the system, including degree certificates, academic certificates, technical qualification certificates, post qualification certificates, etc.
Item bank management
The item bank management module supports the multi-category design of test questions, including multiple-choice questions (single choice, multiple choice), fill-in-the-blank questions, true or false questions, short answer questions and so on. The system supports the automatic generation of test papers from the question bank of documents according to the number and types of test questions required by personnel. The system supports the wrong question analysis function. After scoring, the correct answer can be displayed, which provides the basis for answering questions. When the file is updated, the system will also inform the instructor in real time to update the content of the question bank in time.
Examination management
The examination management module provides examination management functions, including setting examination papers and examination times. , to ensure that students master the training content and improve the training quality. You can automatically generate test papers and random questions according to the question bank. For objective questions, the system can automatically mark and score. Support make-up exam function, can analyze the wrong questions that do not reach the full mark, and have the function of answering the wrong questions again. The system supports make-up exam functions, including the number of make-up exams and passing scores. During the assessment period, the system supports anti-cheating settings, including screen capture, reduction, screen capture and anti-hanging settings.
Lecturer management
Instructor management module has independent training instructor management function, and supports the approval process of instructor qualification application, modification and invalidation. Support the maintenance of internal lecturer and external lecturer functions. The system can import trainer qualifications in batches. The training instructor files entered into the system can be updated in real time, including name, age, position, professional title, teaching scope, teaching course list, evaluation feedback, etc.
Task notification
The task notification module supports multi-channel notification systems, including email, enterprise WeChat, system notification, WeChat, SMS, nailing and other multi-channel message notifications; Help improve timeliness and response speed. It can avoid the wrong distribution of core courses and make the training of enterprises compliant; Automation: tasks can be assigned automatically, reducing management workload; Security: It has the functions of authority control and audit trail to ensure the security of training data.
Training evaluation
Training evaluation module has the ability of real-time tracking and evaluation, which can help enterprises grasp the training progress and understand the training effect in real time, adjust and improve the training content and form in time, and ensure the effectiveness and compliance of training. Provide training matrix summary function, support multi-dimensional view of training results, evaluate employee training, and ensure that employee training achieves corresponding results. The training evaluation module has built-in pre-job evaluation of new employees, new post evaluation of employees and annual evaluation of employees. The system also supports user-defined evaluation items.
Certificate management
The certificate management module supports the setting, editing and issuing of post certificate templates; The post certificate is consistent with the provisions of the corresponding documents. When the document requirements or position templates change, the position certificate template can be automatically updated after the new document or template takes effect. The dynamic information such as personnel information, working time and post information in the certificate can be automatically matched by the system. At the same time, the system supports setting the validity period of post certificates, and can set expiration reminders, such as sending a notice one month before the qualification expires.
Brand course
The brand course module has built-in a large number of excellent courses, which are jointly created by authoritative institutions such as Kanglihua Consulting, Yunzi Medicine and Singedi Health * * *, such as GMP related laws and regulations interpretation, drug GCP, verification series, quality management QA system, production series and other course types.
Singedi's Total Quality Solution
With nearly 20 years of professional experience in the quality industry, Singedi's total quality solutions have helped many listed companies and small and medium-sized enterprises to realize the digital transformation of quality business, and helped users achieve the goals of improving product quality, reducing management costs, reducing enterprise operation risks, improving industry compliance and improving customer satisfaction.