All Documentation required by GMP Regulation is issued, managed and controlled by a Document Management System such as batch related documents as M-aster Batch Records - Processing and Packaging Instructions, Raw Data Records, Distribution Records, Standard Operating Procedures, Specifications, Test Methods and non batch related documents such as Qualification and Validation Documents, Complaint and Recalls Records, Environmental Monitoring Records, Utility Monitoring Records, Change Control Documentation, Engineering Drawings, Maintenance and Calibration Records, Equipment Logs, Personnel Training Records, Technical Agreements, Investigation and Reporting Records, Cleaning and Sanitization Records, Entry Records for Controlled Areas, Pest Control Records, Stability Records, Audit Reports, Regulatory Files, etc.
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Changes to architectural documents imply change control of the documentation.
对体系结构文档的更改意味着更改对文档的控制。
What is the procedure for change control system for the documentation?
文件变更控制体系程序是怎样的？
The change control system is a collection of formal documented procedures that define how project deliverables and documentation are controlled, changed, and approved.
变更控制系统是正式形成文件的过程的全体，用于确定控制、改变和批准项目可交付成果和文件的方式、方法。
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