Document Management System (DMS) for the Pharmaceutical Industry

Businesses in the pharmaceutical industry, whether small or large, are being faced with regulatory requirements that have proved complex, time-consuming, and growing by each day. Additionally, such companies are faced with a significant amount of paperwork that results from various operations involving medical, tax, and accounting regulations. With such administratively-intensive practices, it is crucial that pharmaceutical businesses adopt a document management system.

Having a document management system enables your pharmaceutical business to file scanned documents, forms, attachments, and emails automatically into a virtual filing cabinet, which helps to reduce any administration tasks and errors. By investing in a document management system, you can protect sensitive customer data through encryption, monitor efficiency, identify bottlenecks by having access to real-time work performance reports, and have your documents arranged in an organized manner for easy retrieval.

Some of the main documents that you can store and protect using a document management system for the pharmaceutical industry include:

• Customer information

Data on customers helps validate clinical studies and therefore hold great importance in supporting clinical trials and gaining FDA approvals in subsequent versions of the drug under trial. It is important that such information is well documented, filed, and protected from unauthorized access. Protecting such documents is also mandated under FDA regulations, and by getting a document management system to help with this, you will be taking the right steps toward upholding compliance.

• Clinical documents

A typical clinical study can last for up to 10 years and involve various documents on such matters as the study, patient enrollment, clinical study sites, and sponsors, among others. When the documents are collected, they help form the study’s TMF (trial master file). This documentation, which is important in the marketing phase, must be compiled, organized, and protected, therefore a need for a document management system.

• Pre-clinical documentation

A lot of work and time is put into the formalization of the right combination of biological and chemical substances used in making the new drug. During this phase, there is a significant amount of documentation that is created regarding chemistry and biological tests, and animal and laboratory studies. Therefore, in a bid to handle such documentation while ensuring compliance with FDA regulations, it is important to implement a document management system.

Benefits of investing in a document management system for the pharmaceutical industry

• Regulatory compliance by ensuring the availability of audit trails in stored information
• Reduced duplicated and redundant information
• Automation of major pharmaceutical document workflows
• Restricted access through enhanced information security
• Improved quality of data
• The presence of a repository that helps store and manage documents through the various stages of the clinical trials.