Reed Tech™ and Schlafender Hase® are leaders in the life sciences industry, working together to help ensure that pharmaceutical companies and their products are compliant with global regulatory standards. Both companies understand and solve industry challenges with responsive solutions. 

Industry Challenges

Pharmaceutical companies operate in a highly regulated industry with countless regulations, mandates and deadlines that require fast turnaround times and, above all, accuracy. Both Reed Tech and Schlafender Hase strive to continuously meet these high standards.

Industry Requirement

Structured Product Labeling (SPL) is a Health Level Seven® (HL7®) International standard for regulatory guidance documents as a method for communicating product and facility information. Accepted by the U.S. Food & Drug Administration (FDA), SPL enhances the cohesiveness and honesty of product information, because it requires reliable structure and standardized terminology. SPL documents consist of not only the content of labeling (text, figures and tables), but also information about the product (drug listing data elements) that is machine-readable. 

The SPL specification was created to assure that there was a consistent way to develop labeling content. By using an established method for product labeling, enhancements and improvements can be attained throughout every step of the process, from the creation to the distribution of labeling content by industry and health authorities. The labeling of products is a crucial part of product life cycle management. 

Process Hurdles

Complicated: The procedure of product labeling is detailed, complicated and closely monitored. The content that the product label contains is very precise, especially regarding its safety data and adverse effects. With so many parties within the healthcare system relying on accurate information, it is problematic for one party to misinterpret another’s message. SPL solves for clear communication with regulated classifications. 

Many FDA divisions have required SPL since June 2009, including the Center for Biologics Evaluation and Research (CBER), Center for Veterinary Medicine (CVM), Office of Non-Prescription Drugs (ONPD), and Center for Devices and Radiological Health (CDRH). Other divisions, like the Center for Drug Evaluation and Research (CDER), have followed the requirement since October 2005. 

Cumbersome: Before a product is placed on the market, all accompanying instructions for use and artwork must be audited for accuracy and formatting. Manually editing technical documents creates a risk for errors. In the early days of providing file conversions services, Reed Tech quickly recognized this risk potential and sought a solution to minimize proofreading time and gain accuracy. As a best-in-class solutions provider, it was important for Reed Tech to establish data-quality processes using innovative software tools. The team tested several software programs that claimed to automatically compare Microsoft® Word to PDF and PDF to XML. At the end of the testing phase, the results from TVT were impressive. Reed Tech selected TVT from among other competitors as the tool of choice. 

Reed Tech is an industry leader in Structured Product Labeling (SPL) preparation, submission and life-cycle management for Pharmaceutical Establishment Registration and Product Labeling and Listing with 20+ years of experience preparing XML files and 15+ years supporting the pharmaceutical industry, starting with the initial 2005 U.S. FDA requirement for drug labeling to be submitted in the SPL format. 

As part of LexisNexis® and RELX Group®, Reed Tech has the bandwidth and capabilities to offer unparalleled support to handle volume spikes and help ensure all SPL conversions are delivered on time. The team acts as an extension of your regulatory team, equipped to handle night, weekend and holiday support. Reed Tech has delivered over 55,000 drug listings for more than 1,000 pharmaceutical manufacturers and distributors. 

Reed Tech supports the preparation and submission of a comprehensive list of SPL document types related to labeler code registration, establishment registration and drug labeling/listing for numerous scenarios including brand, generic, Rx, over the counter, human, animal and biologic. Other scenarios include API for further processing/finished for contract manufacturing organizations and private label distributor. In addition, Reed Tech supports special FDA reports for Generic Drug Facility Self-Id, Biologic Lot Distribution, REMS (Risk Evaluation Management System), Drug Sample Distribution Data (Affordable Care Act 6004), etc. Its core functionality includes data ingest, data validation, workflow, storage, version control, reporting, audit trail, SPL build and submission and export abilities. Reed Tech is 21 CFR Part 11 compliant. 

Schlafender Hase has created TVT®, the Text Verification Tool®, a software that verifies text, spelling, barcodes and artwork. This tool, originally developed in 2003, helps prevent misprints by inspecting files with different layouts and file formats to catch deviations early in the process. Schlafender Hase also allows TVT to be integrated into existing workflows at Reed Tech to help ensure that only approved content is printed or published. TVT is designed to be compliant with FDA and EMA by supporting SPL and QRD templates. TVT ensures compliant, error-free and consistent packaging. 

As best-in-class solutions providers, it was important to both Reed Tech and Schlafender Hase to establish quality, reliable working relationships to help ensure data quality and the very best outcomes for mutual customers. The team at Reed Tech tested several software programs that claimed to automatically compare Word to PDF and PDF to XML. At the end of the testing phase, the results from TVT, along with its reputation as the industry-leading proofreading tool on the market, led Reed Tech to select it from among its competitors as the tool of choice. The streamlined proofreading capability of TVT enhances the data quality output provided by Reed Tech.

Learn more about medical device product data management at Reed Tech