Problems of manual documentation in the pharmaceutical industry
                     Manual Documentation in the 
Pharmaceutical Segment – Problems 
(Analysis)
Document Classification in Pharmaceuticals
Document Classification in 
Pharmaceuticals
   For Organization & Personnel
   For Buildings & facilities
   For Equipment
   For Handling of R.M.& P.M
   For Production & process control
   For Packaging & Labeling control
   For Holding & Distribution
   For Laboratory Control
   For Records & Reports
   For Return & Salvaged finished products
Types of Documents used in 
Pharmaceuticals
Types of Documents used in 
Pharmaceuticals
   Medical specifications document
   Standard Operating Procedures (SOP documents)
   Test procedure documents
   Equipment list documents
   Analysis certificate documents
   Labels
   Medical records
   Organogram
   Medical job description documents
   Medicinal products manufacturing records
Challenges & Pain points in Manual 
Documentation
Problems of Manual Documentation in 
Pharma
 Document versioning issues
Problems of Manual Documentation in 
Pharma
 Unmanaged SOP Changes
Problems of Manual Documentation in 
Pharma
When multiple groups 
contribute to a project, 
producing a final report can be 
difficult to manage
Problems of Manual Documentation in 
Pharma
Outdated emergency procedures
Problems of Manual Documentation in 
Pharma
Problems in auditing the 
accounts
Problems of Manual Documentation in 
Pharma
Productivity issues in the  
manual documentation work
Problems of Manual Documentation in 
Pharma
Inefficient batch record 
processes – Ex: Scribal errors, 
illegal values, missing values in 
the batch record documents
Problems of Manual Documentation in 
Pharma
Inadequate data tracking in the 
paper-based documentation 
methodology
Problems of Manual Documentation in 
Pharma
Disconnected systems & lack of 
communication in between the 
pharmaceutical departments
Problems of Manual Documentation in 
Pharma
Issues in managing the high 
variability / dynamic nature of 
manufacturing segment in 
pharmaceuticals
Problems of Manual Documentation in 
Pharma
Difficulty in managing the 
medical sector with respect 
to the compliance regulations
Thank You
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