GMP Quality Management System (QMS)
Due to the high attention paid by regulatory authorities to the pharmaceutical industry, pharmaceutical enterprises are currently facing unprecedented compliance pressures and challenges. Hippocrates QuaTrust® GMP Quality Management System (QMS) is a software system that meets both quality management standards and regulatory requirements. The quality management of products must meet the standards to satisfy the strict audits and inspections of customers and regulatory authorities; any unfavorable audit results may directly affect the company's profitability. Driven by the multiple pressures of regulatory compliance, process streamlining, cost reduction, and brand protection, pharmaceutical enterprises have generally regarded QMS informatization as one of the top priorities in their overall digital transformation. A scalable, flexible yet reliable quality management system now plays a crucial role and is a key link that every successful enterprise must attach importance to in realizing its quality vision and sustainable development. After more than a decade of development and continuous improvement of solutions, Hippocrates QuaTrust® GMP Quality Management System (QMS) has become the preferred digital quality solution for many leading pharmaceutical enterprises.
Enterprises shall establish a quality management department and a quality assurance system, which shall perform their duties independently to ensure the effective operation of the quality management department. The Qualified Person (QP) is mainly responsible for drug release and shall perform their duties independently to ensure that the production and inspection of each batch of released drugs comply with relevant regulations and drug registration management requirements.
Enterprises shall conduct self-inspections annually to assess the effectiveness of drug quality assurance measures and propose necessary corrective and preventive actions. Enterprises shall conduct regular audits on the operation of the quality management system to ensure that their production conditions, technical capabilities, and quality management continuously meet the quality requirements for drug production and relevant regulatory requirements.
Enterprises shall establish a change control system to evaluate and manage all changes that affect product quality. Changes requiring approval from drug regulatory authorities shall be implemented only after obtaining approval.
Enterprises shall establish operating procedures for deviation handling, specifying the procedures for reporting, recording, investigating, handling deviations or the corrective actions to be taken, with corresponding records kept.
Enterprises shall establish a CAPA system to investigate and take corrective and preventive actions in response to complaints, recalls, deviations, results of self-inspections or external inspections, process performance, and quality monitoring trends. The depth and form of investigation shall be commensurate with the risk level. The methods adopted by the CAPA system shall be capable of improving products and processes and enhancing the understanding of products and processes.
Enterprises shall identify the qualification or validation work required to demonstrate that the key elements of relevant operations can be effectively controlled. The scope and extent of qualification or validation shall be determined through risk assessment.
Enterprises shall establish drug marketing release procedures, clarify the factory release procedures and marketing release standards, review the drug production records, inspection records, deviation investigations, etc., and the drugs can be released for marketing only after being signed by the Qualified Person (QP).
Enterprises shall, in accordance with operating procedures, conduct a detailed review of all complaints and other information regarding potential quality defects of products. For all complaints about product defects, detailed records of all aspects of the complaint shall be kept, and a thorough investigation shall be conducted.
Enterprises shall establish a product recall system to enable the rapid and effective recall of all batches of products with quality defects or suspected quality defects from the market when necessary. Except for cases where there is evidence to prove that the quality of returned products is not affected, products returned or recalled due to quality reasons shall be supervised and destroyed in accordance with regulations.
Enterprises shall establish a material supplier management system and management files, and establish a list of qualified suppliers. When changing a material supplier, a quality audit or assessment of the new supplier shall be conducted; when changing a major material supplier, it is also necessary to conduct relevant validation and stability studies on the product.
OwlTrust® is a digital platform jointly developed by Hippocrates's industry experts and IT experts. With the management concept and market positioning of "Quality Compliance Expert", it helps enterprises improve their quality compliance level, meet industry supervision, enhance enterprise management capabilities, and accelerate the marketing of more safe, effective, and quality-reliable products. QuaTrust® Quality Management System (QMS) is one of the core systems on the Hippocrates Owltrust® platform.
Hippocrates QuaTrust®GMP Quality Management System (QMS) is developed based on the pharmaceutical industry, designed by pharmaceutical industry quality management experts, and supported by Kanglihua Consulting for compliance assurance. The 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 GAMP 5. The quality management system provides enterprises with a quality management system that meets global regulatory requirements, featuring flexible modular components, enabling enterprises to more easily deploy on-demand throughout their digital transformation. The system focuses on empowering the QA (Quality Assurance) departments of pharmaceutical enterprises, helping enterprises ensure the effectiveness and reliability of the entire quality management system, so as to meet the requirements of relevant domestic and foreign laws, regulations, and supervision. At the same time, it improves the operational efficiency of the quality management system, reduces the costs of manual operations and paper-based systems, and ultimately helps customers produce high-quality and trustworthy drugs, and enhance the overall quality management level.
The Change Management module can automatically manage all tasks related to change control, including change type, change tracking, and approval. The automation function helps streamline the standardized execution environment and assists enterprises in better complying with standards and specifications. It enables centralized management of all documents related to change control, making updates, searches, and retrievals easier.
By configuring the default functional assessment scope, the Change Management module can conduct mandatory scope assessments for certain types of changes to ensure the rationality and accuracy of change assessments. Meanwhile, the module supports the formulation of change implementation plans and tracks the execution of the plans.
The Deviation Management module is an important part of the Hippocrates QMS integrated suite and can be seamlessly integrated with other quality process applications of QMS. For example, deviation events can be associated with audits and customer complaints. It can automatically complete data collection, storage paths, tracking, and reporting of deviation events.
The Deviation Management module can track all path information and data entered in electronic forms, enabling users encountering deviation issues to quickly identify the problem and understand the consequences of quality events during the handling process. It integrates the complete electronic approval process and guides users through the best-practice process to better resolve deviation events, from initiation to verification and resolution. Through seamless integration with QMS CAPA, more serious events can be immediately transferred to the remediation/prevention process for verification and resolution.
The Deviation Management module has a built-in RPN (Risk Priority Number) scoring mechanism and supports custom weights for each dimension.
The CAPA Management module automates the CAPA management process and provides best-practice functions to help users select data.
CAPA provides an "out-of-the-box" configuration, including a set of pre-packaged electronic forms, workflows, and business analytics. It automatically inputs and initiates information from different information sources, automatically inputting and linking information related to deviations, non-conformities, customer complaints, audits, and other issues that may trigger the corrective action process to the CAPA process.
The CAPA module enables automatic task assignment; for example, data entry and approval are automatically assigned to personnel or departments in the form of workflows. When a new CAPA-related task is generated, the system automatically notifies the corresponding user. It supports CAPA action plans and effectiveness checks (formulation of action plans, execution of action plans, and effectiveness checks).
The Audit Management module supports the in-depth integration of the audit process with other quality systems and modules to achieve the most effective quality management method. The audit process is connected with audit findings, which streamlines the process and ensures that issues identified during the audit are properly resolved. It can automatically perform task assignment, follow-up, reporting, review, and approval of audit documents. Among them, the master audit plan can plan the enterprise's annual audit plan. In addition, the system manages tasks required for various audits, such as preparing checklists, recording audit findings, and audit follow-up.
The audit process supports multiple ways to create audit plans (e.g., attachments, online audit forms, uploading to generate audit forms). It also supports real-time entry and effective tracking of audit findings.
The audit calendar sending function supports one-click export of audit calendar files, ensuring that the email system can easily open calendar audit events and send them to auditees. By integrating different stages, the Audit Management module streamlines the audit process, including: planning and scheduling, audit findings/reports, confirmation, and completion. Audit findings can record all findings during the audit process. The form integrates risk management functions to assess risks and collect the following information: risk category, severity, likelihood of recurrence, and whether CAPA is required. The system can directly initiate another form (e.g., audit finding form) in the CAPA form. The corresponding information in the audit finding form is automatically entered into the CAPA form, thereby reducing manual data entry errors. The audit summary is used to record basic information such as audit type, date, description, objectives, scope, audit areas, and lead auditor.
The Complaint Management module automatically arranges all tasks related to customer complaints, including data collection, notification, tracking, and reporting of overdue unfinished tasks.
The standardized complaint management process can realize the following functions: correctly recording customer complaints, collecting complaints, ensuring that the enterprise can obtain relevant information in a timely manner regardless of who receives the complaint, conducting timely investigations, coordinating solutions, and shortening the complaint handling cycle (from submission to resolution).
The best-practice process for complaints is part of a pre-configured multi-page form, which includes three main parts: customer complaint handling, automatic transfer to the content investigation stage, and successful resolution of the problem.
The Supplier Management module standardizes the supplier access process and qualification requirements, provides real-time feedback on supplier delivery quality, conducts regular supplier performance evaluations, tracks supplier rectification, and ultimately improves the supplier quality level.
The Supplier Management module enables online collaboration among relevant departments within the company, procurement departments, suppliers, and service providers, improving the accuracy and timeliness of information transmission and enhancing the overall efficiency of the procurement business process.
The Task Notification module supports a multi-channel notification system, including email, WeChat Work, system notifications, WeChat, SMS, DingTalk, and other channels for sending and receiving message notifications; it helps improve the timeliness of handling and response speed. It can avoid omissions in process links and make the enterprise's quality processes more compliant. In terms of automation: it can automatically assign tasks and reduce management workload. In terms of security: it has permission control and audit trail functions to ensure the security of quality data.
With nearly 20 years of professional experience in the quality industry, Hippocrates's comprehensive quality solutions have helped many listed companies and small and medium-sized enterprises realize the digital transformation of quality business, assisting users in achieving the goals of improving product quality, reducing management costs, lowering enterprise operational risks, enhancing industry compliance, and improving customer satisfaction.
Since its establishment in 2006, Hippocrates has gone through nearly 20 years of development. It has always adhered to the original aspiration of "creating social health value through technology", centered on customers, and based on the life and health industry (pharmaceuticals, medical devices, food, cosmetics, etc.) to provide customers with cutting-edge technology-based digital solutions. It helps enterprises improve quality and compliance levels, reduce operational risks, enhance business operation efficiency, reduce costs, and realize intelligent management; it also promotes the digital transformation of the industry and empowers the industry value chain. So far, Hippocrates has provided services and products to the following enterprises:
As a one-stop solution, Hippocrates GMP Quality Management System (QMS) addresses the complex regulatory requirements of the pharmaceutical industry. With the core focus on the compliant and efficient handling of processes such as changes, deviations, CAPA, OOS/OOT (Out of Specification/Out of Trend), audits, release, complaints, returns, and non-conforming product handling, it provides enterprises with a complete business solution. It helps enterprises achieve full compliance in quality event management and real-time transparent monitoring. While improving the degree of data utilization, it precipitates past experience in the form of knowledge for analysis and reuse, enabling data to empower the business in all aspects. It enhances employees' understanding and compliance with GMP, thereby improving the quality and safety of the production process.
