Optimizing Validation Processes for Digitization: Why Paper to Glass Isn’t Enough
Optimizing validation processes for digitization is crucial for organizations that want to take full advantage of the benefits of digital transformation. The traditional paper-based processes are slow, error-prone, and resource-intensive. Digitization, however, allows organizations to streamline their processes, reduce costs, and increase efficiency.?Learn how in our Digital Validation Handbook.?
Digitization refers to the process of converting analog information into digital format. This includes data, images, and other forms of content that can be stored and accessed electronically. Digitization involves the use of technology to capture, process, and store information in a way that is easily accessible, searchable, and shareable.?
Digitization is becoming increasingly important in highly regulated industries as organizations strive to modernize their operations, keep up with technological advancements of the Industry 4.0 revolution, stay competitive, and?underpin commercial performance. Digitization allows for greater efficiency, accuracy, consistency, and speed in processing information, and increased accessibility and flexibility in sharing information.?
Limitations of Paper-to-Glass Approach?
The “paper-to-glass” concept refers to the transition from paper-based processes to digital processes. It involves the use of electronic devices—such as computers, tablets, and smartphones—to access and process information instead of using paper-based documents.?
Paper-to-glass, in general, focuses on digitizing documents to make validation more efficient?using scanners to help streamline document transfer and readability. The process typically involves?scanning paper documents and transmitting their digital files to stakeholders. Some solutions allow?for editing of a “layer” on top of the document, whereas others require the document to be printed,?manipulated, and then rescanned.?
This approach can remove the storage headaches of fully paper-based systems and greatly speeds the hand off of key documents, but it does not necessarily result in increased efficiency or accuracy. The scanning required means cycle times will still be longer than a?fully digital solution, and data integrity risks remain as key aspects (such as approval signatures)?happen offline?and may not be time stamped accurately. This also does little to utilize data within the documents, which limits the efficacy of a paper-to-glass solution. In fact, it can even create new limitations, such as:?
Lack of Integration With Other Systems??
Many highly regulated organizations still rely on multiple systems and applications to manage their processes, such as quality management systems (QMS), Laboratory Information Management Systems (LIMS), Enterprise Resource Planning (ERP) systems, and Document Management Systems (DMS), as well as other digital tools.?
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If these systems are not integrated, it can lead to inefficiencies, duplicate data entry, and errors. For example, if information is entered into multiple systems, it can be difficult to ensure that the information is consistent and up to date across all systems.??
To overcome this limitation, organizations need to implement strategies to integrate their systems and applications. This can involve the use of middleware or application programming interfaces (APIs) to connect different systems and allow for seamless data transfer and sharing.??
Challenges in Managing and Storing Electronic Documents??
Another limitation of the paper-to-glass approach is the difficulty in managing and storing electronic documents. While electronic documents can be easily shared and accessed, they can also be difficult to organize and manage, particularly if there are large volumes of documents.??
Organizations need to implement strategies to manage and store electronic documents effectively. This can involve the use of document management software, which allows for easy organization, search, and retrieval of documents. It can also involve the implementation of policies and procedures to ensure that documents are properly labeled, categorized, and stored.?
Ensuring Data Security??
One of the biggest concerns with digitization is data security. Electronic documents are vulnerable to hacking, data breaches, and other forms of cyber threats. In addition, electronic documents can be easily copied, shared, and distributed, which can increase the risk of unauthorized access and data leaks.
To address these concerns... head over to the?full article?on our?Kneat blog.