The management of GMP documents and records in pharmaceutical enterprises is not only an important core component of GMP quality assurance system in pharmaceutical enterprises, but also the basis, basis and norm of all activities. Facing more and more complicated internal processes and stricter external compliance requirements, the number of GMP documents and business processes are becoming more and more complicated. In the whole pharmaceutical production process, thousands of documents and forms are used to solve the drafting, approval, countersigning, approval, training, distribution, receiving, modification, auditing, filing, printing and recycling of documents in a traditional manual way, which brings management.

(1) introduction of DMS file management system

Akso eGMP DMS file management system is a file system designed around GMP requirements. The whole process from drafting, joint review, examination and approval, publication, entry into force, revision, issuance, reissue, printing, version upgrade, review and invalidation is controlled according to GMP requirements, and the whole life cycle management of documents for review and log tracking is realized according to the authority control function. It can effectively control the approval management, version control, authority allocation and log tracking of files, which is convenient and easy to use. Support multi-party online collaborative editing of documents, making cooperation smoother and more efficient, and also support effective management of file distribution, record receipt and payment, and balance.

(3) Outstanding advantages

1, file association:

You can concatenate all upstream, downstream and horizontal files. In system management, when the content of a node changes, it will notify the relevant files, so that the owners of these files can check and confirm, which can effectively identify the contradictions and omissions between various processes, ensure the consistency of all file contents, and will not make the executors make mistakes and confusion.

2. Efficient collaboration:

Support online collaborative editing, online annotation and other functions of documents, and relevant parties of document management can collaborate online immediately, which greatly improves the work efficiency of documents.

3. Full-text search:

Powerful content search function, you can find all the titles and contents of SOP with one click, and realize the query without dead ends.

4, mobile office:

Documents can be approved at any time, not limited by work area, and can also be approved by mobile phone, which shortens the file circulation time and improves efficiency.

5. User-defined reports:

You can check the status of files at any time, identify bottlenecks and risks in file management, provide trend warnings and share them with team members and partners.

For more information, you can download Akso Egmp dms from Baidu.