Collaborative Solution for Contract Manufacturing Quality Management (OWL MAH)
Hippocrates's "Collaborative Solution for Pharmaceutical Contract Manufacturing Quality Management" (referred to as "OWL® , OWL MAH®") is rooted in the pharmaceutical industry. Jointly designed by contract manufacturing management experts and quality management experts, it provides compliance assurance. The platform features flexible modular components, allowing enterprises to easily deploy on-demand throughout their digital transformation journey. Its design strictly adheres to standards and regulations such as GMP, ICH, FDA, cGMP, EU-GMP, and ISPE GAMP5, and complies with MAH regulatory requirements. It ensures the effective connection between the quality management system of the holder and that of the contracted manufacturer, ultimately helping the holder effectively reduce management costs and improve risk control capabilities.
The MAH system stipulates that the Marketing Authorization Holder (MAH) is the main responsible entity for pharmaceutical contract manufacturing. Regulations detail the responsibilities that holders and contracted manufacturers should fulfill, as well as the standards to be met in various activities, as follows:
OWL MAH is integrated with multiple sub-module systems based on the AOTAI Platform, including Document Management System, Training Management System, Quality Management System, Pharmacovigilance System, and Electronic Contract System. The AOTAI Platform has built-in configuration tools that enable the realization of MAH-specific processes without customization or programming. It can quickly customize forms, decision trees, and dashboards to meet the quality management collaboration needs between MAH holders and contracted manufacturers. It simplifies and accelerates approval and release processes, effectively ensuring that quality documents, records, reports, etc., are highly shared, transmitted in a timely manner, signed in real time, and stored for a long time between holders and contracted manufacturers, thereby effectively reducing management costs and improving risk control capabilities. The specific sub-modules are as follows:
The Document Management System (DMS) ensures that holders establish effective document management procedures, including: drafting, revision, review, approval, replacement or revocation, duplication, storage, and destruction of documents; document numbering and version control to ensure the validity and traceability of documents; regular review of documents to ensure their applicability; and timely mutual notification with relevant contracted enterprises of all key document changes involving contract manufacturing and sales activities.
The Training Management System (TMS) ensures the effective implementation of personnel roles and responsibilities in the holder's enterprise; it also ensures that personnel receive necessary training, such as pre-employment training and continuing training. Corresponding training matrices can be established for personnel in different positions, and various types of training plans (e.g., new employee training, retraining, annual training) can be formulated based on these matrices. Training is then conducted in accordance with the plans, and all training courses are accompanied by corresponding assessments and records, which can help the holder's enterprise evaluate and review training effectiveness.
The Quality Management System (QMS) integrates functions such as deviation management, CAPA, change management, release management, audit management, validation, complaint management, return and recall, and risk management. It can help holders fully implement quality management throughout the contract manufacturing process and ensure the effectiveness and reliability of the entire quality management system, thereby meeting regulatory and supervisory requirements. The release management module ensures that the production and inspection of each batch of released pharmaceuticals comply with relevant regulations and pharmaceutical registration management requirements.
(IV) Feature 4: Pharmacovigilance System (PVS)
The Pharmacovigilance System (PVS) integrates modules such as pharmacovigilance system documents, regulatory database, training, courses, quality management processes, electronic signatures, and SAE (Serious Adverse Event) assistant. It supports the full business process of compliant and efficient individual case collection, processing, reporting, and analysis. The system covers individual case safety management in different stages of pre-marketing and post-marketing of products. Singerdi's Pharmacovigilance System (PVS) can help holders quickly establish a pharmacovigilance business operation system that meets regulatory and supervisory requirements.
The Electronic Contract System (eSign) has built-in agreement templates for the entire contract manufacturing process, such as Contract Manufacturing Agreement Template and Contract Manufacturing Quality Agreement Template, helping holders sign contract manufacturing agreements and quality agreements that meet regulatory requirements with contracted manufacturers. The system supports multi-party document signing, signing reminders, attachment addition, and other functions. It adopts effective technologies to ensure the real identity of signing parties, prevent document tampering, and accurately record the signing time. It also protects enterprise data (transactions, documents, and files) through encryption methods, thereby ensuring the confidentiality and integrity of the holder's data. The Electronic Contract System widely supports various business scenarios of contract manufacturing.
The workflow module includes process management software tools. By modeling, automating, managing, monitoring, and optimizing the entire lifecycle of internal and external business processes of an enterprise, it solves business problems and helps enterprises improve profits.
Relying on the workflow platform, collaborative and standardized management of various quality processes can be realized, such as audits between MAH enterprises and suppliers, change control, and finished product release.
III. Solution Value
(1) Core Value 1: Meeting Communication Mechanism Requirements
It helps holders establish a comprehensive communication mechanism with contracted manufacturers, defining the types of information to be communicated, communication methods, and timeframes. This ensures that all types of information related to the quality of contract-manufactured pharmaceuticals are shared and assessed in a timely and sufficient manner during the contract manufacturing period, effectively preventing quality risks and compliance risks arising from ineffective communication.
(2) Core Value 2: Meeting Contract Manufacturing Management Requirements
Through the platform, holders and contracted manufacturers sign the Contract Manufacturing Agreement and Contract Manufacturing Quality Agreement, ensuring the implementation of the legal obligations stipulated in the Drug Administration Law and various quality management requirements specified in the Good Manufacturing Practice (GMP) for pharmaceuticals.
(3) Core Value 3: Meeting Marketing Release Management Requirements
It helps holders establish pharmaceutical marketing release procedures, review the finished product release procedures of contracted manufacturers, define marketing release standards, and review the pharmaceutical production records, inspection records, and deviation investigations of contracted manufacturers. Pharmaceuticals can only be released for marketing after being signed off by the Qualified Person (QP).
IV. Application Scenarios
(1) Application Scenario: Quality Management Collaboration for Pharmaceutical Contract Manufacturing
Hippocrates's Collaborative Solution for Pharmaceutical Contract Manufacturing Quality Management (OWL MAH) is developed in accordance with the regulatory requirements of China's Marketing Authorization Holder (MAH) system. With a focus on the compliant and efficient handling of processes such as documentation, training, electronic contracts, pharmacovigilance, change management, deviation management, CAPA, OOS/OOT (Out of Specification/Out of Trend), audit, release, complaint management, return, non-conforming product handling, and risk management, it provides MAH holders with a complete collaborative solution for contract manufacturing quality management. It ensures that quality documents, relevant records, and reports are highly shared, transmitted in a timely manner, and effectively stored between holders and various contracted parties, simplifying and accelerating the approval and release processes between holders and contracted manufacturers. It ensures the effective and close connection between the quality management systems of holders and contracted manufacturers, thereby enabling the fulfillment of corresponding responsibilities for contract manufacturing quality management and ensuring that the contract-manufactured pharmaceuticals are safe, effective, and of controllable quality.
V. Technical Information
(I) Overall Architecture
AOTAI is a digital platform jointly created by Singerdi's industry experts and IT experts. With "Quality and Compliance Expert" as its management philosophy and market positioning, 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 Collaborative Solution for Pharmaceutical Contract Manufacturing Quality Management (OWL MAH) is one of the core solutions based on Singerdi's AOTAI Platform.
Applications on the AOTAI Platform can be customized into quality systems according to enterprise needs. The built-in configuration tools already include multiple functions of quality solutions, so no customization or programming is required to implement certain special processes. Trained personnel can quickly customize forms, decision trees, and dashboards to meet specific business needs.
The functions of the Collaborative Solution for Pharmaceutical Contract Manufacturing Quality Management include: main functional modules such as organization and personnel management, document and training management, record and release management, pharmacovigilance, and quality assurance and control. Among them, quality management includes modules such as supplier management, deviation management, event (OOX) management, CAPA management, change management, audit (self-inspection) management, validation management, complaint management, recall management, and risk management. The above roadmap clarifies the phased implementation path of the solution.
Quality and compliance processes are built on common master data, which only needs to be set up once and can be used in different modules of the entire system. New processes will automatically reference these data dictionaries to ensure that enterprises continue to use a "common language" as their quality systems evolve. The characteristics of the technical architecture include: the organizational hierarchy configuration is completely consistent with the company structure; it supports the aggregation or further viewing of detailed data at any level; and access to different organizational nodes in complex hierarchies can be restricted.
The superior design of the AOTAI Platform ensures that users can quickly access large volumes of records and data, thereby improving work efficiency. The "intelligent loading" of forms minimizes loading time. Frequently used data is cached to maximize network bandwidth utilization. Data is stored in an effective manner, and the distributed architecture is optimized for server expansion. Standard APIs greatly improve system access efficiency, including: automatic email notifications, SMS notifications, and dashboard alerts integrated into the workflow, which greatly reduce the risk of missing tasks or approvals. The background task submission and management mode supports users to perform other tasks simultaneously. A standard intermediate service layer is provided to support integration with any third-party system, facilitating data exchange between AOTAI and other application systems.
