Download - Documentation Management By Sneha
DOCUMENTATION MANAGEMENT
Presented By,Sneha Deshpande
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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.
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Documents filed in Pharmaceutical Industry
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Systematic Classification
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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.
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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
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FDA Guidelines on GDPs Cont..
Table 1: Commonly used Error codes with examples7
FDA Guidelines on GDPs Cont..
• General Practices:
– Follow SOPs– Document revision no– Correct dating– Employee training record
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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
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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
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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.
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Document management system (DMS)Cont..
• Mathematically;• Document Management = (Content Management) + (Attribute Management)
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Electronic Document management System (EDMS)
Few such EDMS are enlisted below.•ColumbiaSoft8
•OpenDocMan9
•MetricStream10
•M-Files13
Electronic Document management System (EDMS)
• Basic components of any EDMS:– Import tool– Tool for storage– Indexing tool – Distribution tool– Security measures
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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
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• Software features Cont..
Fig: Centralized document storage system offered by M- Files
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• 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.
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• To achieve compliance success: – Software system under use is updated– documents and procedures are validated– Periodic audit trails– backup copy of all records
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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.
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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
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