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Establishment of GLP Programs
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QAI Transitions Pharmaceutical Firm from Paper to Digital

 

Background & Challenges

Quality Associates Inc.’s client is a U.S-based pharmaceutical company that develops pioneering    drugs to improve the lives of people everywhere. The firm’s research constituted more than 100,000 printed documents, which were stored within folders in nearly 25 full-sized file cabinets.  But simply having these archives was not enough; the process of locating needed files forreference or auditing purposes wasted valuable time, and information could not be readily exchanged among the firm’s multiple locations.

As with any pharmaceutical firm, document security was a major concern. The firm’s reliance

on paper documentation meant that important records and reports could be misplaced due to employee error. Documents were also in danger of being damaged or even permanently lost as a result of an unforeseen disaster such as fire or flood.

Storage was another challenge. As boxes of files piled up, the firm knew that accessing the

files once they were moved to a remote offsite facility for long-term storage would make them even less accessible to staff.

Solution

The pharmaceutical firm decided to take a new approach and selected Quality Associates Inc. (QAI), a GSA Federal Supply Service (FSS) contractor. Founded in 1986, QAI has developed a strong track record in providing data conversion and archival services and systems for local, state, and federal government agencies, and private firms in regulated industries such as healthcare, finance, and legal.

QAI provided a complete services approach that provided the required staffing and technology resources. First, Quality Associates’ worked with the firm to understand their requirements. Then, QAI performed a pilot phase to make sure that printed documentation was transferred into digital format properly and met the client’s specifications before the rest of the work began. After the successful completion of the pilot phase, QAI established an off-site service bureau at its secure headquarters in Fulton, Maryland.

Specifically, QAI converted the electronic documents into searchable PDFs. Once converted,QAI performed quality control steps to ensure the clarity and accuracy of the captured content. QAI also verified that all electronic documents were fully compatible with the pharmaceutical firm’s Intranet. As QAI processed each “batch” of documents, it sent the images back to the firm on DVDs via overnight mail. This process provided the client with more convenient and continuous access to the documents throughout the project.

Results

The pharmaceutical company quickly received a comprehensive digital library housing all of its printed documentation. In fact, it took QAI only 30 days to scan, convert and perform quality assurance for the entire 100,000 document collection of print archives.

The firm then made the images accessible via its secure Intranet. Now, staff and researchers at the pharmaceutical company no longer need to search for research documentation within rooms full of file cabinets. Needed research documents can be found quickly and easily right from their desktop computers.  Internal audits are also easier because information is accessible with just a few clicks of the keyboard. Now, staff can focus on their work – and not locating the right document.

Scott Swidersky, director, Information Systems Division, Quality Associates, said,

“Pharmaceutical companies, by the nature of their work, perform extensive research

and long-term studies. In addition, maximizing staff resources and minimizing product

development lifecycles are critical for many of these organizations to remain productive

and successful. Thanks to new advancements in document conversion and archiving,

research staff can save precise time and effort because information is, literally, a few

keystrokes and clicks away.”

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