[Audio] Trackwise writing Technique. 02. 03. 04. 01. 

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1
 Indicates Good Quality Assurance and Control Benefits 2
 Traceability Benefits 3
 Knowledge Preservation Benefits 4
 Regulatory Compliance Benefits 5
 Shows Quality and Consistency Benefits 6
 Historical Data Analysis Benefits 7
 Avoids the risk in personnel interpretations Benefits 8
 Clarity and Efficiency Benefits 9
 Effective Communication Benefits 10
 Helps in understanding the discrepancy. Benefits 11
 Helps in audit data pulling. Benefits 12
 Keeps auditor happy Benefits 13
 Quality is not only in product but also in how we express. Benefits 14
 Helps in data trending. Benefits 15
 Saves time in searching multiple documents to understand the issues. Benefits 16
 Saves time by avoiding addendums and corrections. Benefits

[Audio] Here we are going to see trackwise writing technique in four different headings. 

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[Audio] Good Documentation Practice (G-D-P--) is a direct requirement of the Code of Good Manufacturing Practice (G-M-P--). It ensures the manufacture or quality assurance/ control of the product is not negatively impacted potentially enhancing product quality and patient safety.. 

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Good Documentation Practice (GDP) is a direct requirement of the Code of Good Manufacturing Practice (GMP). It ensures the manufacture or quality assurance/ control of the product is not negatively impacted, potentially enhancing product quality and patient safety.

1
 Indicates Good Quality Assurance and Control Benefits

5
 Shows Quality and Consistency Benefits

7
 Avoids the risk in personnel interpretations Benefits

10
 Helps in understanding the discrepancy. Benefits

11
 Helps in audit data pulling. Benefits

13
 Quality is not only in product but also in how we express. Benefits

15
 Saves time in searching multiple documents to understand the issues. Benefits

16
 Saves time by avoiding addendums and corrections. Benefits

[Audio] Let's see the benefits of Good writing in trackwise.
Good writing in trackwise Indicates Good Quality Assurance and Control.
Traceability.
Knowledge Preservation.
Regulatory Compliance.
Shows Quality and Consistency.
Historical Data Analysis.
Avoids the risk in personnel interpretations.
Clarity and Efficiency.
Effective Communication.
Helps in understanding the discrepancy.. 

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[Audio] Helps in audit data pulling.
Keeps auditor happy.
Quality is not only in product but also in how we express.
Helps in data trending.
Saves time in searching multiple documents to understand the issues.
Saves time by avoiding addendums and corrections.. 

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A screenshot of a computer

Description automatically generated  Keeping fields as empty

02. 03. 04. 01. 11 Helps in audit data pulling. Benefits. 

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A screenshot of a computer

Description automatically generated  Performing easy job rather than updating what is reviewed

02. 03. 04. 01. Examples. Track wise –Writing Technique. 

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A screenshot of a computer

Description automatically generated  Not providing sufficient information on the discrepancy

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A screenshot of a computer

Description automatically generated  Not writing the conclusion of investigation

A close up of a sign

Description automatically generated  Feeding unwanted details

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For OOS: Date of identification: Date of occurrence: Test parameter: Observed result.: Test limit: Specification name and number: Analyst name: Analysis date: Equipment name and ID: What to be

02. 03. 04. 01. Track wise –Writing Technique. A screenshot of a computer Description automatically generated Not writing the conclusion of investigation. 

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For Deviation: Date of identification: Date of occurrence: Discrepancy: Against what: Equipment details: Document details: Product details: Material details: Personnel details: What to be

02. 03. 04. 01. Track wise –Writing Technique. What to be & How to be. 

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For Generally All possible details need to be transcribed. For tables/graphs/diagrams, capture the summary/Inference of the section Attach respective attachments and give reference of the attachments Choose most appropriate root cause and sub cause. Choose “others” only in case of root cause which does not fit under any categories. Repeats and repeat trends needs to be carefully marked and ensure all the previous occurrences can be traced in sequentially. What to be

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Write “Not applicable” only in place of absolute fit
 Not writing “refer document”
 Traceable on tomorrow
 Should not create confusion.
 No unapproved abbreviations  (u, y, wt, wr, ASAP)
 Simple language
 3rd person should understand
 Should be short with 100% meaning.

Should be short with 100% meaning.. 02. 03. 04. 01. 

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Write “Not applicable” only in place of absolute fit

No unapproved abbreviations  (u, y, wt, wr, ASAP)

02. 03. 04. 01. Track wise –Writing Technique. Write “Not applicable” only in place of absolute fit. 

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PowerPoint Presentation

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Here we are going to see trackwise writing technique in four different headings

Good Documentation Practice (G-D-P--) is a direct requirement of the Code of Good Manufacturing Practice (G-M-P--). It ensures the manufacture or quality assurance/ control of the product is not negatively impacted
 potentially enhancing product quality and patient safety.

Let's see the benefits of Good writing in trackwise.
Good writing in trackwise Indicates Good Quality Assurance and Control.
Traceability.
Knowledge Preservation.
Regulatory Compliance.
Shows Quality and Consistency.
Historical Data Analysis.
Avoids the risk in personnel interpretations.
Clarity and Efficiency.
Effective Communication.
Helps in understanding the discrepancy.

Helps in audit data pulling.
Keeps auditor happy.
Quality is not only in product but also in how we express.
Helps in data trending.
Saves time in searching multiple documents to understand the issues.
Saves time by avoiding addendums and corrections.

PowerPoint Presentation

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