Digital Archiving in the Pharmaceutical Industry

Posted by Lauren Ford on Jun 17, 2015 7:23:36 AM
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All over the pharmaceutical industry, both businesses and patients depend heavily on the integrity and confidentiality of archived records. In the highly regulated world of drug manufacturers, properly preserving documentation is a critical requirement for business continuity. As technology continues to advance, medical corporations need to embrace document management solutions, eSignature capabilities and the benefits of automating workflow processes to help ensure the wellbeing of patients, business and the pharmaceutical industry.

 

Minimize Compliance Risks

The U.S. Food and Drug Administration’s basic rules for the validation of electronic records and electronic signatures are outlined in an extensive compliance regulation, known as CFR part 11. One major advantage of implementing a digital content management system is the simplicity of falling into compliance with CFR part 11. In the pharmaceutical industry, a high level of confidence in the longevity of records is needed because the business depends on the information contained. A document management software system can preserve documentation for an infinite length of storage time while protecting the look and feel of original documents, a key element of preservation under CFR part 11.

Maintaining compliance with HIPAA is another complex, yet mandatory regulation for organizations in the healthcare field. Within this system, policies must be set company-wide to protect data from being wrongfully modified. A singular document management repository automatically logs which user performed an action to a document, which documents were modified, where within a document changes were made and when the action occurred. Document management software can simplify how patient information is handled by effortlessly transforming pharmaceutical businesses into HIPAA compliant providers.

Eliminate Costly Storage

Along with traditional Human Resources paperwork, such as payroll information and sensitive employee onboarding documents, pharmaceutical companies retain a large number of files including lab data, clinical research records and databases of raw prescription data. From a knowledge management and compliance point of view, all of this information is crucial to business so it must be properly stored.

Regulatory requirements define a two-year retention period for all documentation supporting the filing for a new drug approval. Yet patent disputes or legal actions from patients can dictate a whole new set of rules for documents and data retention. Because of this risk, many pharmaceutical companies retain paper copies indefinitely, but also experience astronomical storage costs to do so. By implementing an electronic document management system, pharmaceutical firms are able to reduce 80% of storage costs including file cabinets, folders and printing materials, while also freeing 40% of office space.

Improve Document Accessibility & Time Management

The ultimate goal of effective records management is fast, easy and accurate retrieval. Considered knowledge based organizations, pharmaceutical companies have a constant need to access records in their archives and distribute them to a variety of internal and external agents. Through advanced document workflows, a document management system allows stored files to be accessed and shared immediately, often without manual intervention.

Aside from opening office space and improving data entry, several pharmaceutical organizations are choosing to archive records digitally within a singular document management system to eliminate time management issues by streamlining collaboration and cutting document retrieval from a matter of hours to mere seconds. Embracing document management solutions, medical corporations can now effortlessly replace the inefficient flow of paper based files with an automated stream of data and documents to serve more patients at a faster rate.

Consequently, the pharmaceutical industry is now dealing with increasingly more records that originate in digital format. These electronic records hold dynamic content and features that need to be preserved, worked with and accessed over time. Digital archiving software simplifies the management of documentation to streamline productivity while ensuring confidentiality to provide pharmaceutical firms the ability to stay current with trends in technology.


GlobalSearch Document Management provides organizations in the pharmaceutical industry with a comprehensive system that complies with the required privacy and retention regulations of maintaining confidential medical documentation, while ultimately improve business processes. GlobalSearch’s built-in, proven technology accommodates pharmaceutical firms of all sizes with the tools to fully integrate into existing business application, provide record retention automation across all departments, safeguard sensitive patient data and monitor all user document activity. To learn more, schedule a demo today!

Topics: Paperless Office, Compliance, Document Management Software, Digital Storage, Enterprise Content Management