To ensure that enterprises stably produce pharmaceuticals that meet quality standards and intended uses, GMP (Good Manufacturing Practice) compliance training is mandatory and crucial in the pharmaceutical industry. With the strengthened supervision of pharmaceutical enterprises by regulatory authorities in China, the United States, Europe, and other regions, as well as the increased emphasis on quality traceability of pharmaceutical enterprises, there is a growing requirement for pharmaceutical enterprises to continuously enhance the management and control of the reliability of quality system data. Since training is a fundamental element of the quality assurance system, digital management of training has attracted increasing attention from pharmaceutical enterprises.
The pharmaceutical industry has a multitude of regulations and standards covering a wide range, resulting in complex and strict training requirements for employees. Therefore, employees need to understand and comply with various GMP standards, including requirements related to pharmaceutical production, quality control, equipment cleaning, and employee hygiene.
Drug regulatory authorities frequently update and revise GMP standards and regulations. Enterprises need to promptly understand and adapt to the new requirements to ensure that training content is updated in a timely manner and complies with the latest regulations.
Pharmaceutical enterprises involve a variety of positions and job responsibilities, and each position has specific GMP training needs. The training content and formats for different positions need to be customized, which brings great difficulties to management and maintenance.
For large-scale pharmaceutical enterprises, there are a large number of employees and various positions. How to uniformly manage and supervise the implementation of training plans and the evaluation of training effects is a challenging task.
Pharmaceutical enterprises need to track and evaluate the training effects of employees, but the existing tracking and evaluation mechanisms may be insufficient, making it difficult to objectively assess the effectiveness of training and the compliance level of employees.
OwlTrust® is a digital platform jointly developed by Hippocrates's industry experts and IT experts. With the management concept and market positioning of "Quality and Compliance Expert", it helps enterprises improve their quality and compliance levels, meet industry supervision requirements, enhance enterprise management capabilities, and accelerate the launch of more safe, effective, and high-quality products. The Training Management System (TMS) is one of the core systems on the Hippocrates Owltrust® platform.
Rooted in the pharmaceutical industry, the Hippocrates GMP Training Management System (TMS) is designed by pharmaceutical industry quality management experts. Its product design strictly adheres to standards and specifications such as GMP, ICH Q7a, FDA 21 CFR Part 11, cGMP, EU-GMP (ANNEX 11), and ISPE GAMP5. The Hippocrates GMP Training Management System (TMS) fully meets the industry regulatory requirements for the training system. It supports diverse training formats to meet the learning needs of different trainees, enhancing the flexibility and convenience of training. At the same time, it enables real-time tracking of training progress and effects, manages training records, and automatically generates statistical reports, facilitating preparation for audits at any time and improving the transparency and efficiency of management. The TMS supports integration with the Hippocrates DMS (Document Management System) or third-party DMS. It can automatically generate courses from documents that require training, realizing seamless connection between training and the document system and improving management convenience.
The Training Matrix module is mainly used to formulate corresponding on-the-job training tasks for the enterprise's in-service employees and realize real-time management of training progress, thereby achieving closed-loop management of the entire training business process. It supports training needs for different scenarios such as induction training, job transfer training, and periodic training. Through the matrix, training administrators can effectively manage the company's compliance training tasks and avoid incorrect or missed assignment of training tasks. Meanwhile, when the document status changes (e.g., document version upgrade, document freezing, document revocation), the system can automatically identify and update the matrix.
Based on the job training matrix, the Training Planning module supports the automatic generation of personal annual/monthly training plans. The training plan includes course selection, version management, plan progress management, permission assignment, audit trail, matrix view display, and automatic task assignment. It also supports tracking the completion status of each item in the annual plan, as well as conducting annual reviews and statistics.
The Training Archive Library supports three access modes: employee self-viewing, training administrator viewing, and official inspection needs. It can clearly list the training task list, completion rate, specific exam scores, and the qualification certificates obtained by employees (including certificate validity periods) by year, month, and day. It supports the management of standardized archive templates and allows manual upload of existing employee basic information into the system, including academic degree certificates, educational certificates, technical qualification certificates, and on-the-job qualification certificates.
The Question Bank Management module supports the design of multiple question types, including multiple-choice questions (single-select and multiple-select), fill-in-the-blank questions, true/false questions, and short-answer questions. The system can automatically generate test papers from the question bank according to the number of questions and question types required by users. It supports error analysis: after scoring, the correct answers can be displayed along with the basis for the answers. When documents are updated, the system will also promptly notify trainers to update the question bank content in a timely manner.
The Exam Management module provides exam management functions, including setting test papers and exam attempts, to ensure that trainees master the training content and improve training quality. It can automatically generate test papers based on the question bank, with random question selection. For objective questions, the system can automatically mark and score the papers. It supports make-up exams, allows analysis of incorrect answers for scores not reaching full marks, and provides the function of re-answering incorrect questions. The system supports setting the number of make-up attempts and the passing score for make-up exams. During the assessment period, the system supports anti-cheating settings, including settings for interface screen switching, window minimizing, screen capturing, and anti-idling.
The Trainer Management module has an independent training trainer management function, supporting the approval process for trainer qualification application, revision, and cancellation. It supports the management of internal and external trainers and allows batch import of trainer qualifications. The profiles of trainers entered into the system can be updated in real time, including information such as the trainer's name, age, position, professional title, teaching scope, list of courses taught, and evaluation feedback.
The Task Notification module supports a multi-channel notification system, including message notifications via email, WeChat Work, system notifications, WeChat, SMS, and DingTalk. It helps improve the timeliness of processing and response speed, avoids incorrect or missed assignment of core courses, and ensures the compliance of enterprise training. It enables automation: automatic assignment of tasks to reduce management workload. It also ensures security: with permission control and audit trail functions to protect the security of training data.
The Training Evaluation module has real-time tracking and evaluation capabilities, helping enterprises grasp training progress in real time, understand training effects, and promptly adjust and improve training content and formats to ensure the effectiveness and compliance of training. It provides a training matrix summary table function, supporting multi-dimensional viewing of training results and evaluation of employee training to ensure that employee training achieves the corresponding effects. The Training Evaluation module has built-in evaluations such as pre-employment evaluation for new employees, evaluation for employees in new positions, and annual employee evaluation. At the same time, the system supports custom evaluation items.
The Certificate Management module supports the setting, editing, and issuance of job certificate templates. Job certificates are consistent with the provisions of corresponding documents. When document requirements or job templates change, after the new documents or new templates take effect, the system can automatically update the job certificate templates. Dynamic information in certificates, such as employee information, on-the-job date, and position information, can be automatically matched and completed by the system. The system also supports setting the validity period of job certificates and can set expiration reminders (e.g., sending notifications one month before the qualification expires).
The Brand Courses module has a large number of high-quality built-in courseware, developed by a team of senior industry experts. These courses include systematic and series-based content such as GMP-related regulatory interpretation, pharmaceutical production management, testing and validation, quality management, and digital solutions.
With its professional experience in the quality industry, Hippocrates's comprehensive quality solutions have helped many listed companies and small and medium-sized enterprises achieve digital transformation of quality-related businesses. It has assisted users in achieving goals such as improving product quality, reducing management costs, lowering enterprise operational risks, enhancing industry compliance, and increasing customer satisfaction.
Adhering to the original aspiration of "Using Technology to Create Social Health Value" and focusing on customers, Hippocrates is rooted in the life and health industry (pharmaceuticals, medical devices, food, cosmetics, etc.) and provides customers with cutting-edge technology-based digital solutions. It helps enterprises improve quality and compliance levels, reduce operational risks, enhance business operation efficiency, lower costs, and achieve intelligent management. It also contributes to the digital transformation of the industry and empowers the industry value chain. So far, Singdi has provided services and products to the following enterprises:
As a one-stop solution, the Hippocrates GMP Training Management System (TMS) addresses the pain points of the pharmaceutical industry, such as complex regulatory requirements, diverse job requirements, and frequent regulatory updates. It provides core functions including comprehensive compliance, real-time transparent monitoring, training matrix, brand courses, and diverse training formats. With the support of these functions, pharmaceutical enterprises can effectively manage and implement training plans, enhance employees' understanding and compliance with GMP, and thereby improve the quality and safety of the production process.
