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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