Paperless Documentation in Pharmaceutical Industry
As a QA personnel I have some nightmares like:
-How many filing cabinets will require to keep every batch record organized in order to manufacture your products?
-Are there numerous papers that require review?
-Are any documents missing?
Many people view maintaining paper records as a necessary evil. The benefits of switching to digital records outweigh the initial headache, and there is excellent software available today to assist you in going paperless.
Find below ten reason why we should move to paperless:
1. Storage
Over the course of any given product’s lifetime, you will accumulate mountains of paperwork, but electronic records take up far less space.
2. Record Retention and Recall
The more paperwork you have, the harder it may be to find records during an audit and waste valuable time doing so. You can easily search for and locate any information you require when your records are in electronic format.
3. Searchable
You can quickly locate the information you need by conducting a data search on individual or group records. It can help you in troubleshooting production or quality control issues if you have the ability to search for specific data.
4. Data Available for Trending
Want to know how a new component is doing in comparison to an old one? Are you trying to identify potential areas of concern in your manufacturing process? The information is much more easily accessible for data trending and analysis when electronic records are used.
5. Less Missing Information
Electronic records are easier to monitor and can assist operators in completing paperwork completely, even in cases where operator error or complete absence of paperwork occurs.
6. Accurate
Dates are consistently exact and generated by the system. You can rely on the accuracy of your records since time is never retroactively or forwardly dated. The need to interpret handwriting is also lessened by using drop-down menus and operator-entered data.
7. On-the-Spot Validation
While no one is flawless, conditional formatting and records with built-in limitations can help you get closer. Limits and conditional formatting can notify an operator of an issue before more resources and time are used when they enter data that does not match your production standards.
8. Materials Management
You can use electronic records to link your MMS and plan the use of materials or reagents.
9. Reduce Operator Error
Calculation by hand is risky business. With records that perform the calculations for you, make sure your recipes and parts are produced in accordance with your standards from lot to lot.
10. Electronic Signatures
Moving entirely to an electronic system is made easier by the use of electronic signatures in electronic records.
Now its up to us to think whether we do tedious jobs or go paperless to make life easier.
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Resource Person: Md. Ayub Hossain
