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Chemveda Confidential. . Document Control & Data Handling at Chemveda.

Chemveda Confidential. 2. Document control:-. Document: Document is any written statement or proof of any activity and it is required to minimize the risk of misinterpretation, Error inherent in oral and written communication to provide unambiguous procedure. Document control : Document control can be defined as a series of practices that ensure that documents are created, reviewed, distributed, and disposed of in an organized and verifiable manner. What is a document according ISO 9001? According to ISO Documents communicate information, provide evidence of conformity, and allow for knowledge sharing. ISO 9001 requires an organization establish, document, implement, and maintain a quality management system and continually improve its effectiveness..

Chemveda Confidential. 3. Document control:-. QMS documentation includes: Quality Policy: A quality policy is a brief statement that aligns with your organization's purpose, Mission and strategic direction , it provides a framework for quality objectives , and includes a commitment to meet applicable requirements (ISO 9001, customer, statutory or regulatory) as well as to continually improve. Quality Manual: A Quality Manual is a top-level document that describes an organization's Quality Management System (QMS). It can be used both internally (for employees) and externally (for customers and auditors)..

Chemveda Confidential. 4. Document control:-. 3. Documented procedures: ISO requires documented procedures that must be controlled. These activities include:.

Chemveda Confidential. 5. Document control:-. Additional documents may be needed to demonstrate an effective QMS. These documents must be controlled as well. Examples of these are: Quality objectives Process maps, process flow charts and/or process descriptions Organization charts Specifications Work and/or test instructions Documents containing internal communications Production schedules Approved supplier lists Test and inspection plans Quality plans.

Chemveda Confidential. 6. Document control:-. The key steps in the document control procedure are: Importance of Document Control:-.

Chemveda Confidential. 7. Document control/Data handling at Chemveda.

Chemveda Confidential. 8. Document control:-. Overview Documents & Numbering System at Chemveda: Quality manual : CVL-QM-000 2. Site Master File : SMF – 0.0 3. Validation Master Plan : VMP – 00.

Chemveda Confidential. 9. Document control:-. 4. Equipment Qualification protocols (Installation, Operation, Performance): XX/YY/ZZZ-RR 5. Equipment Qualification protocols (URS/ Design qualification) : VVV/ YY/ XXX/ZZ-RR.

Chemveda Confidential. 10. Document control:-. 6. Re-Qualification of Equipment’s : RQ/XXX/YY/ZZ-RR 7. Software Qualification Protocols (URS/ SRS) : VVV/ YY/ XXX/ZZZ-RR.

Chemveda Confidential. 11. Document control:-. 8. Software Qualification Protocols & Reports (Installation, Operation, Performance, Operation Performance Qualification): VVW/YY/XXX/ZZZ-RR 9. In-House Specification (IHS) Specification Numbering: CVL/IHS/YY/ZZZ.

Chemveda Confidential. 12. Document control:-. Lab Note Book: Lab notebooks shall be issued to the user department and the issuance and retrieval details shall be documented as per the lab note book issuance and retrieval record. Handling Data at Chemveda: Authorization of documents Preparation & Approval Master Copy Control/Uncontrolled copy/Issue Obsolete.

Chemveda Confidential. 13. Document control:-. Authorization and issuance of Loose Attachments / Printed books Format request form Document/Format issuance record”. QA representative shall photocopy required number of Attachments of the master copy and stamped with “issued by” with QA sign & date Formats/Log books retrieval (Formats/ log books retrieval ).

Chemveda Confidential. 14. Document control:-. Authorization of validation and Qualification protocols preparation of final version of protocol ‘MASTER COPY’ QA shall issue the validation or Qualification attachments/Formats of the protocol. Execution.

Chemveda Confidential. 15. Document control:-. Document validity : SOPs shall be effective for 2 years from the effective date unless reviewed and revised during the validity period. User department shall review the respective SOP’s and if there is any change, SOP shall be revised through document change request system. If no changes are required to be made following a review, the user department will inform to the QA through IOC (Inter office communication) After the review, if no changes are found in SOP, then master copy & controlled copies of the SOP shall be stamped as “SOP Reviewed Next date of review & Approved by sign & date” Vertically on the left side corner of the first page of the SOP to extend the validity period for another two years..

Chemveda Confidential. 16. Document control:-. Retention and control of Records: According to our SOP the following Documents Should not Destroyed. Destruction of document:.

INDIA USA. www.chemvedals.com. Chemveda Confidential.