Medical device industry

Every step of production requires strict process approval and execution, establishing a unified database to quickly retrieve required information and achieve information resource sharing

Industry background

The pharmaceutical equipment industry is the core research object of national life sciences, which is related to the ecological health of the people. The development speed of medicine and medical devices keeps up with the pace of the times. Pharmaceuticals must strictly follow the GMP drug production quality management standards, and there are extremely strict requirements for the integrity, authenticity, and traceability of data, records, and documents closely related to drug quality. Every step of production requires strict process approval and execution, establishing a unified database to quickly retrieve required information and achieve information resource sharing

Pain points

The document modification does not go through the approval process, personnel positions are adjusted without following the approval procedures, and the offline document management process is complex

After an employee resigns or transfers, project documents are lost or leaked, resulting in the leakage of industry secrets

The speed of document transfer and borrowing is slow, and documents are stored locally, making it difficult for colleagues on business trips to access them

Difficulty in tracking the production process and inability to identify the cause of problems; There are no relevant records of deviations in production and the handling of non-conforming products, making it difficult to trace data

The large number of files makes version control difficult, files are difficult to access, and storage costs increase

The data is scattered and stored on employees' computers, and the computer hardware is damaged, resulting in the loss of all files and affecting work progress

Solution

The Runpu Document Control Management System strictly regulates the management of GMP system documents throughout their entire lifecycle, including document editing, review, modification, distribution, borrowing, retrieval, and destruction

Document control management

1

Project management provides a separate project communication platform for various medical projects, customizes approval processes, strictly follows the approval process for standardized production, supports electronic signatures, and enables quick approval

Project Management

2

Medical archives are stored and archived, and project completion archives are automatically archived in the project archive management area. Runpu archive management is a comprehensive management system in the medical industry that mainly implements electronic archive management, supplemented by paper-based management

Archive management

3

Strictly divide document operation and usage permissions, unify the management of confidential documents, and ensure the security of document use

Permission management

4

The file history operation is recorded in the form of a report to ensure traceability afterwards. Errors in file operations can be backed up and restored