QMS(Quality Management System)
Quality Management System (QMS) is a set of systems and methods used to manage and control quality-related activities, including deviation management, change management, CAPA management, supplier management, verification management, nonconforming product management, batch issuance, release management, complaints, recall, annual review, annual review and other modules. Features and functions such as quality document control and management, process management and optimization, risk management and evaluation, change control and management, nonconforming product management, internal audit and evaluation, and external partner management help ensure product quality stability, compliance, and continuous improvement and optimization of product quality.
The main Parts of QMS system is shown in the following figure:
The main features of the QMS system are as follows:
Deviation management: Support according to the enterprise process to set up in accordance with GMP requirements of the custom deviation management process, flexible setting of process parameters, timely alarm, QA confirmation release, automatic generation of deviation ledger.
Change management: Support to set a custom change management process in accordance with GMP requirements according to the enterprise process, flexibly set the change route, timely alarm timeout, custom process, and automatically generate the change ledger.
CAPA management: Support the establishment of customized CAPA management process in accordance with GMP requirements according to enterprise processes, support CAPA routes of different types and processes, timely alarm of timeout, custom processes, and automatic generation of change accounts.
Batch issue summary: Capture data from batch records, inspection records or auxiliary records, and automatically generate batch issue summary without filling in twice.
Release management: automatically associate production batch related information, easy to query, review and release.
Verification management: Support the automatic generation of verification plan, automatic reminder during implementation, and modify the validation validity period of the device after implementation.
Supplier management: Support supplier information management, support qualified supplier expiration reminder. Implement information management for the whole process of annual supplier audit.
Non-conforming product management: Support the information management of the whole process of non-conforming products, and customize the approval process of non-conforming products.
Customer complaints: Support the information management of customer complaint registration and processing processes.
Product recall: Support the information management of recall process, recall approval, processing, application and other process information management.
Self-inspection management: Support GMP self-inspection planning, process records and reports and other information management.
Printing materials....
Define the limit range and trigger the deviation automatically: