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The pressure for pharmaceutical companies to maintain well organized documentation is extremely high. In addition to the FDA and EMA’s strict regulations, documentation plays a critical role in several stages of pharmaceutical manufacturing. The heavy importance of good documentation in the industry means that digital documentation can provide three powerful benefits to pharmaceutical companies:

  1. Streamlined Documentation Processes
  2. Enhanced Record Keeping
  3. Increased Security

Here are each of the benefits discussed in detail:

Streamlined Documentation Processes

PDF technology revolutionizes the entire documentation process from the thousands of pages required for testing to the employee signatures at the end of each process. Even the process of leaving handwritten notes can be sped up greatly if the pdf technology includes annotation ability.

Signatures and certifications can be entered directly on an electronic document, the input can be done from any device – mobile, desktop or tablet, and all information is automatically backed up and stored. Advanced systems can even monitor the entire process to ensure that each step has been completed, halting manufacturing if a problem is found.

By streamlining the documentation process with digital documentation, you can save both time and money.

Enhanced Record Keeping

One of the biggest benefits attained by making the switch to digital documentation is the ability to greatly improve and speed up the record keeping process. Because documents must be held on file for years (in case of a complaint or recall), it’s crucial to have a great record keeping system in place. Not a single document must be missing, and just one misplaced document can cause a major headache for all parties involved. (Sometimes literally!) Luckily, if your pharmaceutical company uses digital documentation, finding a document is as easy as searching for it by name. PDF technology can turn a day long process of finding documents into a seconds long one.

Documents can no longer be replaced or lost, and with automatic backups and immediate filling, you’re guaranteed to have a complete batch record. This ensures compliance with Good Manufacturing Practices and other regulations. Should an audit occur, records will be readily available and organized.

Another powerful benefit is the ability to search within records. Rather than sorting through an entire record by hand, a pharmaceutical company that uses PDF technology can simply search and locate the right document instantly. Searching within records allows you to identify all documents with a certain manufacturing line (observing performance), pull all information from a specific day, or find every document in a certain batch record. With digital documentation, it’s easier than ever to find and analyze important information, providing executives with the ability to further optimize their business.

Increased Security

Because documents must be signed off by many different employees and departments, it can be tough to track down who had what and when. This can present pharmaceutical companies with a point of major concern as trade secrets and proprietary information must be kept confidential. With paper based record keeping, ensuring that a document stays secure is nearly impossible.

By utilizing PDF technology, a company can password protect sensitive information, limit the ability to view, print and edit documents, and even track who’s done what with each document. In addition to keeping trade secrets safe, electronic documentation also ensures that documents are always backed up and eliminates the risk of physical damage. Digital documentation is the only way you can truly have peace of mind when it comes to your document’s security.

To sum it all up:

Digital documentation can help your pharmaceutical company by:

  • Streamlining the Documentation Practices – With digital documentation, signatures can be electronically entered into the system, ensuring that each step of the manufacturing process is certified to be complete and compliant with regulations.
  • Automatically Compiling Documents into a Complete Batch Record – With all of the documentation already in the system, creating a complete batch record for each manufacturing run is done automatically.
  • Searching Records Electronically – Be able to easily access and pull the specific document you are looking for, whether searching by name, date, or other keywords.
  • Keeping Confidential Information Secure – Password protect and limit access to sensitive information, while storing and backing up documents electronically to ensure they are easily accessible and are not physically damaged.

 

Mobile PDF SDK and WebPDF Viewer are the leading solutions for implementing PDF technology in the pharmaceutical industry. Features such as enhanced document security and permissions API, digital signature API, and more make them go to picks for pharmaceutical companies looking for a blend of security and compliance. Plus, since they’re built on Foxit’s widely used PDF Core technology, they’ll deliver high performance, high reliability, and a plethora of useful features such as annotations, cross platform compatibility, rapid development/integration, and more.