BASF: Electronic Submissions to EPA, EUPOPE, & Canada

BASF contracted with QAI to assist them with a full electronic submission to the Environmental Protection Agency (EPA), EUPOPE, & Canada. The data compiled for these submissions included over 1000 reports totaling more than 1 million pages. The image files were in PDF and single page TIFF format with tagged metadata.

QAI’s expert team of Analysts were brought in to:

Export the data, which consisted of both the reports and their associated metadata, from the document repository (Documentum) at their Research Triangle Park, NC facility.

Transport the exported data back to the QAI Imaging Center located in Columbia, MD and prepare it for the conversion process.

Convert the single page TIFF files to multi-page TIFF documents.

Convert all multi-page TIFF documents to the PDF (image + hidden text) format.

Determine which document attributes were available from the Documentum metadata and provide this information to BASF staff for review (spreadsheet or database format). In some instances, additional attributes were required in order to be compliant with PMRA EDDE submission guidelines and CADDY guidelines. BASF was provided with an input format to enter the additional attributes.

Prepare bookmarks according to the format of the table of contents for each report. Create hyperlinks from the line items contained in the table of contents for each report. Both of these navigational features are requirements of the EDDE guidelines.

Populate the document information fields within the PDF files to contain all of the appropriate information and rename each document according to the EDDE guidelines. This procedure required several steps of concatenation to complete both the file renaming and population of the document information fields.

Master and Labeled CD’s for transport to BASF – Princeton, NJ, & BASF RTP, NC for upload into Core Dossier.

This task consisted of several different initiatives that were coordinated with QAI technical staff and BASF technical staff. The success of these projects enabled BASF to meet timely submission time frames that ensured cost savings and drastically reduced the review process through the regulatory agencies.