Download - Documentation Management By Sneha
![Page 1: Documentation Management By Sneha](https://reader035.vdocuments.mx/reader035/viewer/2022081505/555cbb15d8b42a64718b4833/html5/thumbnails/1.jpg)
DOCUMENTATION MANAGEMENT
Presented By,Sneha Deshpande
1
![Page 2: Documentation Management By Sneha](https://reader035.vdocuments.mx/reader035/viewer/2022081505/555cbb15d8b42a64718b4833/html5/thumbnails/2.jpg)
What is a document?
• Wikipedia defines a document as, a bounded physical representation of a body of information designed with the capacity and is usually intended to communicate.
2
![Page 3: Documentation Management By Sneha](https://reader035.vdocuments.mx/reader035/viewer/2022081505/555cbb15d8b42a64718b4833/html5/thumbnails/3.jpg)
Documents filed in Pharmaceutical Industry
3
![Page 4: Documentation Management By Sneha](https://reader035.vdocuments.mx/reader035/viewer/2022081505/555cbb15d8b42a64718b4833/html5/thumbnails/4.jpg)
Systematic Classification
4
![Page 5: Documentation Management By Sneha](https://reader035.vdocuments.mx/reader035/viewer/2022081505/555cbb15d8b42a64718b4833/html5/thumbnails/5.jpg)
Some statistics!
• On an average, for an aseptic process 74 Controlled design documents and 13 Validation Documents (document revisions are not included) are need to prepare, reviewed and approved.
5
![Page 6: Documentation Management By Sneha](https://reader035.vdocuments.mx/reader035/viewer/2022081505/555cbb15d8b42a64718b4833/html5/thumbnails/6.jpg)
FDA Guidelines on GDPs
• GDP’s for Entering Raw data– No scratch papers. Use only Labnotebooks– Use only pen. No pencils.– Sign & date. No backdating is allowed.
• GDPs on changes made to raw data– Sign and date– Use of error codes
6
![Page 7: Documentation Management By Sneha](https://reader035.vdocuments.mx/reader035/viewer/2022081505/555cbb15d8b42a64718b4833/html5/thumbnails/7.jpg)
FDA Guidelines on GDPs Cont..
Table 1: Commonly used Error codes with examples7
![Page 8: Documentation Management By Sneha](https://reader035.vdocuments.mx/reader035/viewer/2022081505/555cbb15d8b42a64718b4833/html5/thumbnails/8.jpg)
FDA Guidelines on GDPs Cont..
• General Practices:
– Follow SOPs– Document revision no– Correct dating– Employee training record
8
![Page 9: Documentation Management By Sneha](https://reader035.vdocuments.mx/reader035/viewer/2022081505/555cbb15d8b42a64718b4833/html5/thumbnails/9.jpg)
Trends in Warning letters for not following GDPs
• Common Observations:– Documents were not signed– Document Revision number was missing.– Document was either not dated or backdated.– SOP’s were not followed.– Laboratory test records were incomplete. – Employee training records were missing.
Conclusion: All basic mistakes: sign of mismanagement
9
![Page 10: Documentation Management By Sneha](https://reader035.vdocuments.mx/reader035/viewer/2022081505/555cbb15d8b42a64718b4833/html5/thumbnails/10.jpg)
Need for Document management system
• For paper based systems:– 9 +3 =12– Also• Makes 20 copies of each document• Spends $20 on labor to file each of the document• Looses 1 out of 20 office documents• Spends $120 on every misfiled document• Spends $250 recreating each lost document• Spends $25000 to fill four drawer file cabinet and
$2000 annually to maintain it
10
![Page 11: Documentation Management By Sneha](https://reader035.vdocuments.mx/reader035/viewer/2022081505/555cbb15d8b42a64718b4833/html5/thumbnails/11.jpg)
Document management system (DMS)
• Document management (DM) can be defined as; creation, storage, organization, transmission, retrieval, manipulation, update, archival and retirement of documents based on organizational needs.
11
![Page 12: Documentation Management By Sneha](https://reader035.vdocuments.mx/reader035/viewer/2022081505/555cbb15d8b42a64718b4833/html5/thumbnails/12.jpg)
Document management system (DMS)Cont..
• Mathematically;• Document Management = (Content Management) + (Attribute Management)
12
![Page 13: Documentation Management By Sneha](https://reader035.vdocuments.mx/reader035/viewer/2022081505/555cbb15d8b42a64718b4833/html5/thumbnails/13.jpg)
Electronic Document management System (EDMS)
Few such EDMS are enlisted below.•ColumbiaSoft8
•OpenDocMan9
•MetricStream10
•M-Files13
![Page 14: Documentation Management By Sneha](https://reader035.vdocuments.mx/reader035/viewer/2022081505/555cbb15d8b42a64718b4833/html5/thumbnails/14.jpg)
Electronic Document management System (EDMS)
• Basic components of any EDMS:– Import tool– Tool for storage– Indexing tool – Distribution tool– Security measures
14
![Page 15: Documentation Management By Sneha](https://reader035.vdocuments.mx/reader035/viewer/2022081505/555cbb15d8b42a64718b4833/html5/thumbnails/15.jpg)
s
• Introduced by Motive systems Inc.• Type of EDMS
• Software features:– Unique login ID and password – Document vault– creates a separate drive – Check in - check out
15
![Page 16: Documentation Management By Sneha](https://reader035.vdocuments.mx/reader035/viewer/2022081505/555cbb15d8b42a64718b4833/html5/thumbnails/16.jpg)
• Software features Cont..
Fig: Centralized document storage system offered by M- Files
16
![Page 17: Documentation Management By Sneha](https://reader035.vdocuments.mx/reader035/viewer/2022081505/555cbb15d8b42a64718b4833/html5/thumbnails/17.jpg)
• Software features Cont..• Compliance with part 11
Sr. No.
21 CFR part 11 Requirements. Corresponding M-file Features
1 Limited system access Administrator decides the collaborators; thus allowing only authorized users to access system.
2 Authorized personnel have education, training and experience to perform their given tasks.
3 Operational system checks Administrator has the right to conduct the periodic system checks.
4 Electronic signature is legal equivalence of handwritten signature.
Whenever user signs up M- files he has to agree with this part 11 requirement.
17
![Page 18: Documentation Management By Sneha](https://reader035.vdocuments.mx/reader035/viewer/2022081505/555cbb15d8b42a64718b4833/html5/thumbnails/18.jpg)
• To achieve compliance success: – Software system under use is updated– documents and procedures are validated– Periodic audit trails– backup copy of all records
18
![Page 19: Documentation Management By Sneha](https://reader035.vdocuments.mx/reader035/viewer/2022081505/555cbb15d8b42a64718b4833/html5/thumbnails/19.jpg)
Conclusion
• “If it is not written, it does not exists”• Document Management- integral component
of Quality management System (QMS)• “Tech-world”- many E-solutions available• Use of correct solution.
19
![Page 20: Documentation Management By Sneha](https://reader035.vdocuments.mx/reader035/viewer/2022081505/555cbb15d8b42a64718b4833/html5/thumbnails/20.jpg)
References
• http://www.thefreedictionary.com/document, document, as on 11/29/09
• http://en.wikipedia.org/wiki/Document, document, as on 11/29/09
• PME 643 lecture 4: Important Project Documents• http://www.wcaslab.com/qa/sop/2240v4%20-%20Good%20D
ocumentation%20Practices.pdf, GDPs, as on 11/29/09
20