Talk of going paperless started around 1975. Now it’s forty years later and the amount of paper we’re generating is a thousand times greater than it was in the 70’s.
Paperless Validation process in Pharmaceutical Industries
Talk of going paperless started around 1975. Now it’s forty years later and the amount of paper we’re generating is a thousand times greater than it was in the 70’s. It’s unclear why there’s resistance in going paperless especially given the advances in technology making paperless processes markedly more efficient and effective, and less costly. Yet still companies gravitate to paper as a false sense of security in the form of a paper comfort blanket, and the Pharmaceutical industry is all wrapped up in this figurative blanket.
Paper is a figurative comfort blanket providing a false sense of security for the Pharmaceutical industry
Paper Processing Costs
An example of the cost of paper versus paperless processes can be seen in Accounts Payable processes where the cost to handle and process an invoice can be from $20 to $30 per invoice as compared to under $5 for electronic processing. If it costs up to $30 to process paper invoices, how much more does it cost to handle controlled validation documentation given the extra processes involved to generate and maintain the documentation in a controlled state by individuals that are qualified by education, experience, and training? No doubt the answer is it costs hundreds of dollars, on a per document basis, to process validation documentation. Multiply this by the number of times a particular validation document is touched in the process and costs can jump to thousands of dollars on a per document basis.
Electronic Processes Improve Compliance
What are the benefits of paperless validation processes for the Pharmaceutical industry? One benefit is better adherence to regulation. For example, it’s a regulatory requirement that information be readily accessible. When effectively managed, electronic information is more readily accessible. It’s easier to access and distribute information in electronic format compared to obtaining paper documents from file cabinets in controlled document repositories. Getting to the right information is also easier because it’s easier to query data as compared to perusing volumes of paper documents. Furthermore, if a paper document is lost then deviations will need to be written and the lost document will need to be re-created. With electronic documentation, it’s unlikely the document will be lost and, if it is, the document can be restored from a backup.
Benefits of Electronic Execution
Another benefit of validation software is electronic execution. It’s easier to delegate validation tasks electronically compared to splitting up paper-based validation documentation and manually distributing the paper copies to individuals for execution. Electronically, the ability to track progress is automatic whereas with paper it’s a manual effort that experiences delays in compiling and reporting status.
The Bottom Line
Electronic processes have proven benefits, a few of which were identified in this article. All industries are constantly striving towards achieving paperless processes. In addition to improvements in efficiency and effectiveness, and cost savings, paperless processes are better for the environment. Now is the time for companies to explore how they can realize the benefits of paperless processes.
References
Steve Thompson is Senior Manager of Professional Services and is responsible for managing Implementation & Professional Services.
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