Compliance and efficiency, accelerate the digital transformation of pharmaceutical enterprises, and create a new document resource center for pharmaceutical enterprises

GMP/GSP It is the lowest threshold of the pharmaceutical industry , Although since 2019 year 12 month 1 The date of , From law to department regulation , No more GMP Relevant provisions of certification , But canceling certification is not the same as canceling GMP！

For non conformity GMP/GSP/GLP/GCP Required drug manufacturers , Will be ordered to rectify 、 Fines, etc , If the circumstances are serious, the drug approval certificate may even be revoked 、 Drug production license 、 Drug business license, etc .

Good and orderly documents are an essential part of the quality assurance system .

 

In the production and research and development of drugs , Lots of pictures of drugs 、 Clinical report 、 Scientific research materials and other documents are stored on the office computer or attached storage of each department , Not only is it difficult to summarize and control the data , There is also the risk of loss .

Pharmaceutical companies are facing increasingly cumbersome internal processes and increasingly stringent external regulatory compliance requirements , Cloud box replaces the traditional file management , Optimize the document business process of pharmaceutical enterprises through information means 、 Assist pharmaceutical enterprises to safely manage massive amounts of document data .

01、 Build a standardized enterprise document resource center

GMP The central guiding ideology of includes “ All work is documented ”, Make the document the of the enterprise “ law ”, Oppose plagiarism 、 Copy hard copy and execute documents, go through the motions or regard documents as decorations .

Cloud box helps pharmaceutical enterprises build a unified Document Resource Center , except GMP file , Also manage all kinds of administration 、 Research and development 、 Sales and other electronic documents , Such as management strategy 、 Drug formula 、 Sales data, etc , Form a unified enterprise document access portal . An update , Silent global synchronization .

Through the document resource platform GMP file management , Shorten the time of document effectiveness and distribution , Completely empty QA There are mountains of documents to be issued on the engineer's desktop 、 Records to be approved . Improve QA The efficiency of the Department .

02、 Leading safety leakage system

Huge R & D, production and sales data are the lifeblood of pharmaceutical enterprises .

Printed files 、 Uncontrolled electronic data is copied at will 、 Delete 、 Even unauthorized viewing , Even if the content is leaked, there is no trace , The security and integrity of pharmaceutical enterprise data cannot be guaranteed .

The document resource platform has a powerful and leading security system , Protect the security of pharmaceutical enterprise data , Include ： The system is available online at any time 、12 Level authority control 、 Data handover of resignation documents 、 Document and personnel confidentiality 、 Dynamic watermark 、 Anti copy, anti copy, anti screenshot, etc , The authority is strict to control the upload of each document 、 visit 、 preview 、 download 、 Modify etc. .

03、 Quick intelligent retrieval of documents

Massive data can be searched to locate the target file , Document resource platform retrieval function , According to the file name 、 Quick retrieval of document content and number .

For example, by searching “SOP-QA”, Quickly find all quality assurance procedure documents .

There is no dead end in the query result 、 And not affected by equipment 、 Geographical constraints , Personnel can independently check the contents of documents at any time , Don't call QA Department inquiry .

04、 From drafting to approval , Online orderly circulation

from GMP Draft document preparation 、 QA to examine 、 Department review 、 The deputy general manager in charge will take effect after the final approval . The whole process can be carried out with the help of cloud box 【 workflow 】 Realize online automatic circulation approval .

One workflow can set multiple approval nodes , Approvers in the same approval node can approve documents at the same time 、 In the process of flow , Approvers support receiving reminders 、 Modify online 、 Add attachments 、 Electronic signature, etc .

After the process is over , Original document 、《GMP Document drafting / Revision notes 》、 The joint review opinions and other materials will be filed uniformly .

【 workflow 】 Show all unfinished 、 Pending approval , Let everyone involved in the process know the work progress in real time .

05、 Historical version management and review

Always display the latest version of the file in the document resource platform , This avoids QA Department members in the old version WORD Last revision .

Support at the same time WORD Modify online , Automatically generate a new version after saving and submitting .

The document resource platform version does not limit the number of versions , It supports commenting on each version , It is convenient to provide follow-up review clues , In order to investigate the history of suspected nonconforming products .

06、 Audit and log tracking

If in daily GMP Deviation found in the activity , You can return to the document resource platform system for audit tracking , View the operation log of key data , Check who and when , What operations have been performed on the data , And then help find the root cause of the deviation .

The log records of cloud box are all inclusive , As small as the login and logout of personnel , Management changes from administrators , comprehensive 、 Record every action on the system in an all-round way , Satisfy GMP Audit trail control requirements .

07、 Medical data integration and open platform

When the informatization construction of pharmaceutical enterprises reaches a certain degree , There are many internal information systems, which are easy to form data islands .

Cloud box is born with data integration genes , With platform level openness and connectivity , And OA、LIMS、ERP、MES And other information systems integration and docking , Unified identity authentication 、 Unified storage , Data De duplication .

The data of each system flows smoothly through the cloud box , To promote research and development 、 Production and operation management , Improve the management efficiency of all links , Realize the digitalization of business flow 、 automation .

Cloud box meets domestic and foreign GMP and GSP And other medical management norms , So far, it has served Yaojie Ankang 、 Ke Runxi medical 、 Kangqi medicine 、 Ruijing medical 、 Corechi Group 、ChemoPower And many other medical research enterprises , Committed to cutting-edge digital technology , Break the traditional document management in the pharmaceutical industry “ difficult ” and “ slow ” The problem of , Build an easy-to-use 、 Security 、 Intelligent quality document management system of pharmaceutical enterprises .