GMP Document Management System (DMS)
GMP document and record management is a crucial component of the quality assurance system in pharmaceutical enterprises, and it serves as the foundation and benchmark for GMP quality management. In today's era of advanced internet technology, digital management has become an indispensable management model across all industries; the advantages of systematic management—such as high efficiency, meticulousness, and real-time system logging—are particularly prominent in GMP document management for pharmaceutical enterprises.
With the strengthened regulatory oversight of Chinese pharmaceutical enterprises by the FDA and the increased emphasis on quality traceability for domestic pharmaceutical enterprises by the NMPA, enterprises are required to continuously enhance the reliability of internal data. Since documents are a fundamental element of the quality assurance system, digital document management has gained increasing attention from enterprises.
The traditional paper-based + manual management model previously adopted by pharmaceutical enterprises is inefficient yet labor-intensive, directly impacting enterprises' management costs, work efficiency, and the implementation of document management rules and standards. Furthermore, after document content is revised, accurately recalling distributed old versions of documents poses a major challenge to management efficiency. Therefore, addressing the challenges and shortcomings in document management regarding compliance, security, efficiency, and auditability is even more urgent for enterprises under strict supervision, such as those in the life sciences field.
Digital document management systems not only provide comprehensive document management solutions to improve management efficiency but also offer more convenient features for document management due to their online nature. From the initial stage of document drafting or revision, document and process sharing can be realized, allowing approvers and document administrators to view circulation progress and details in real time. After a document is approved or takes effect, the system can immediately notify the document administrator to download, print, and distribute it, while automatically triggering the recall of old versions.
OwlTrust® is a digital platform jointly developed by Hippocrates's industry experts and IT experts. With "Quality Compliance Expert" as its management philosophy and market positioning, it helps enterprises enhance quality compliance standards, meet industry regulatory requirements, improve management capabilities, and accelerate the launch of more safe, effective, and high-quality products. The Document Management System (DMS) is one of the core systems on the Hippocrates Owltrust® Platform.
Hippocrates's Document Management System (DMS) is primarily designed around the GMP requirements of pharmaceutical enterprises. It enables full-lifecycle management and multi-version control of documents across all stages, including document drafting, approval, distribution, release, training, effectiveness, upgrade, reissue, printing, review, and invalidation. The system provides flexible workflows for creating, approving, and modifying documents and Standard Operating Procedures (SOPs). Its streamlined folder structure and quick access links also help users quickly search for target directories and documents.
Hippocrates's DMS includes a full-task management module for document processes, which manages pending tasks, completed tasks, and tasks initiated by the user. Tasks can be filtered based on multiple criteria such as document number/name, task type, status, and progress. For approval tasks, users can click to view approval details; for tasks that are stuck in circulation, users can send a reminder to prompt the responsible person to complete the task in a timely manner, avoiding impacts on document management efficiency.
The system adopts a multi-level folder structure for document management, similar to offline file cabinets, which categorizes and manages all documents in the system in an organized manner.
The system supports the coexistence of multiple versions of document history records. It automatically generates version numbers for each effective version and draft version, enabling traceable sequence management of version iterations. After a document is upgraded, the system automatically triggers a notification for the new version to take effect, allowing relevant personnel to view and read the latest document in the system. At the same time, it triggers a recall reminder for printed copies of the old version to prevent the old version from being misused in production. Additionally, real-time records are kept in the printing ledger to ensure the balance of receipt and distribution of paper copies.
The system supports coding strategies composed of dynamic parameters such as document type, department, version number, serial number, and creation time. When a document or record is created, a unique custom code is automatically generated based on the coding strategy to prevent confusion. When a new version is created due to document upgrade, the custom code is synchronously updated with the version number, while historical versions and their version numbers are retained to facilitate version comparison, management, and traceability.
When a document has an association relationship with other documents in the system, mutual associations can be added. When a document is revised/upgraded or invalidated, its associated documents will receive system reminders. If impacts occur, corrective actions can be taken for the associated documents. The system provides two modes—associated document list and relationship graph—to facilitate administrators in viewing the document association system.
During document drafting, revision, or upgrade, users can use online editing tools to modify content, make adjustments, or add comments. Revisers can also view others' revisions or added comments and comment on these comments. Through efficient online collaboration, the accuracy of document content is verified, avoiding offline repeated communications and multiple reworks. The content edited online is recorded in real time by the system, meeting audit and log management requirements.
For systems with a large number of documents and complex folder management hierarchies, the system supports full-text search of documents using keywords, quickly locating documents and content that meet the search criteria, and enabling quick navigation to the viewing path. The system also supports combined search and filtering using multiple keywords and criteria to quickly locate the desired documents.
Enterprises can customize management and approval processes based on actual scenarios such as document lifecycle, document review, document printing, revision, and borrowing. Approval modes and approvers can be preset based on document type and process, and specific operations and permissions during approval can be implemented through configuration.
Once a process is implemented, administrators can set whether to allow modifications to the referenced process configuration during document drafting. For strictly controlled documents under the GMP system, no modifications to any configuration are allowed, and the documents must be implemented and circulated in accordance with business standards. For other documents such as records and forms with lower confidentiality levels or more flexible approval systems, the system also supports appropriately relaxing restrictions to achieve a more flexible and convenient management and circulation model.
The system can achieve granular permission control through operation menu authorization—setting print operators, printable document types, and printing validity periods. It supports controlling printers, watermarks on printed copies, and controlled printing information such as printer, printing time, and recipient. The system automatically generates a printing ledger to record printing, recycling, and destruction operations in real time.
During printing, batch printing of multiple documents and bound printing are supported. Barcode technology is used to realize the recycling and destruction of paper printed copies or bound documents more quickly and accurately.
For documents requiring training, when the document circulates to the training node, it can be connected to the Training Management System (TMS). The document is automatically transmitted to the TMS and a course is generated; document recipients are automatically added as training participants and receive training tasks. Conditions for automatic training completion (such as "training completion rate") can be set for documents—when the conditions are met, the document is automatically released or takes effect.
In addition, for documents used in offline training, the system supports training administrators to upload training records and manually update the document training status. Whether training is implemented by connecting to the TMS or by manually uploading training records, the document system supports managing and viewing detailed training information of participants.
The system supports sending and receiving notifications via multiple channels, including email, WeChat Work, system notifications, WeChat, SMS, and DingTalk. It covers comprehensive business scenarios such as pending document process tasks, approval result feedback, review reminders, and associated document reminders, helping improve processing timeliness and response speed.
The system provides multi-dimensional document analysis reports, including document status statistics, document revision statistics, document first-pass rate analysis, user task processing analysis, and historical effective version statistics. It supports combined filtering and search based on criteria such as document information, user information, and document status nodes, and allows exporting to Excel locally for more dimensional data statistical analysis.
The system adopts a role-based and permission-based management model to control the modules that users with different identities can view and operate when accessing the document system. Based on document lifecycle nodes or different statuses, the system can set different permissions to ensure the right person views the right content at the right time.
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 achieve the digital transformation of quality-related operations. They have assisted users in achieving goals such as enhancing product quality, reducing management costs, mitigating corporate operational risks, improving industry compliance, and increasing customer satisfaction.
Since its establishment in 2006, after nearly 20 years of development, Hippocrates has adhered to the original mission of "creating social health value through technology." It is customer-centric, rooted in the life sciences and health industry (including pharmaceuticals, medical devices, food, cosmetics, etc.), and provides customers with cutting-edge digital solutions. Hippocrates helps enterprises enhance quality and compliance standards, reduce operational risks, improve operational efficiency, lower costs, and achieve intelligent management. It also facilitates the digital transformation of the industry and empowers the industry value chain. To date, Hippocrates has provided services and products to the following enterprises:
Hippocrates's Document Management System (DMS) not only has comprehensive system functions for full-lifecycle document management but also features open and standard API interfaces. It supports integration with multiple systems such as TMS, QMS, virtual data rooms, and archives to realize data interconnection and sharing.
Hippocrates not only provides solutions to enhance compliance and efficiency for the pharmaceutical industry but also is compatible with and adapts to enterprises' optimal application scenarios. It helps enterprises comprehensively establish and improve a sound digital GMP document management system, contributing to the digital transformation of enterprise quality management.
