The pharmaceutical industry is as much built upon millions of pages of documents as it is upon hard work doing research in a laboratory. Proper documentation of procedures, results, and all manner of other important information is not only important to the efficient undertaking of laboratory work, but is typically a thing demanded by law. Needless to say, to manage documents effectively across all the domains of work being overseen within a single pharmaceutical company requires remarkable organizational ability.
The solution exists in the form of strong document management and control processes designed to keep track of the most important documents to a company’s work. Working in quality assurance and quality control, it’s important to have an understanding of how these processes work, in order to be able to contribute to maintaining them throughout your career.
Want to learn more about document management and control? Here’s what you need to know.
Document Management Is the General Process at the Root of Document Control
Within the pharmaceutical industry, “document management” generally refers to the general processes surrounding documentation. Activities that all within the umbrella of document management include storage, indexing, archiving, and other general activities surrounding the process of capturing the enormous amount of information created in the day-to-day world of the pharmaceutical industry.
Strictly speaking, the specific types of documentation that require document management but not document control often include material that is important to the internal operations of a company, but that isn’t of the highest order of import. Internal communications, contracts, and scanned files are a few of the kinds of records that can typically be said to be managed. It’s important to note, however, that some businesses may use the term “document management” interchangeably with the term “document control,” which is meant to apply to documented material that is critical to the running of an effective pharmaceutical operation. For this reason, professionals just starting out in a career in pharmaceutical quality assurance should be sure to pay close attention to the way their new workplace chooses to define its documenting.
Document Control Is a Higher Priority for Grads of Quality Assurance and Quality Control Courses
Within the pharmaceutical industry, generally speaking, the term “document control” will be applied to the management of the most important types of documents created by a business. This might mean specifications for a drug product, quality control procedures around a particular project, or any number of other highly specialized types of information that must be retained. Because these documents are so important, they tend to be kept around for many years, evolving over time as amendments are made to reflect any changes. Prior instances of the documents are also generally kept, as well as records of the changes made and the justification for making them. The goal here is to ensure required information is accurate and easily accessible when it is needed.
This type of document is immensely important to the healthy functioning of a pharmaceutical company, and draws on many of the skills learned when you study quality assurance and quality control—in adhering to regulatory standards, in correctly documenting essential processes and results, and more. In other words, document control is the type of work that tends to fall squarely within the domain of quality assurance and quality control. If you’re an organized person who loves getting into the nitty-gritty of your work, this is a task that you will probably take to with relish.
Do you want to become an expert in document control in the pharmaceutical industry?
Contact AAPS College to enroll in quality assurance and quality control courses!