Rohm & Haas: Electronic Submissions to EPA, EUPOPE, & Canada

QAI was contracted to provide document conversion support for Rohm & Haas to complete an electronic submission under the PMRA EDDE pilot guidelines. This exercise was conducted only on the reports for environmental fate studies for RH 7281 and Zoxium, which were made available to QAI as hard copies. After reviewing the guidelines, it was apparent that the submission would be most applicable and functional as a portable document format (image + hidden text) submission. The reasons for supporting this format were to maintain the original document as a graphic file while providing the reviewers with full-text search capabilities and increased navigational components. This allows for complex evaluation of the reports with multiple search requirements and provides the regulatory agencies with a non-platform specific format.

The submission was first prepared by collecting and verifying all of the reports required for the submission. Multiple indexes were required to describe the profiles of each of the studies, therefore an MS Access Database was created to maintain and log the appropriate fields. This database then created the File Name and Key Words required by the EDDE guidelines. While QAI’s IT staff was ultimately responsible for the submission, direct input from the scientific staff was required for validating the fielded data and proper recognition of the data fields. The scientific staff reviewed each report for completeness, assigned the DACO number to each study, and filled-in all applicable fields of the database for each report. While the submission was prepared primarily for PMRA, it also went to the EPA. Therefore, the US guideline for each report was also included.

Fielded data were assigned to each report to allow for automatically populating the information fields within the PDF files. The fields were also used to create the actual file name for each of the reports. After the reports were used to populate the fields within MS Access, they were then sent to our scanning facility for conversion to tiff images. The concatenation process used the MS Access database to produce the file name that was then used as the index for each of the documents. Once the documents were scanned and assigned their appropriate file name, the conversion from TIFF to PDF (image + hidden text) started. The next step was to populate the document information field within the PDF file. Utilizing the data produced in the MS Access file, a relation was created by file name and the remainder of the data to populate the assigned fields.

Once this stage was completed an effort began to produce Bookmarks and Hyperlinks. Because this process could not be automated, several people shared the efforts of populating the Bookmarks and Hyperlinks. As a standard method for producing the bookmarks, the original Table of Contents was used to determine the significance of the Bookmarks.

A Visual Basic Program was developed to create the directory structure and naming convention to facilitate the location of the data files. The program was designed to create organized DACO categories. Once the directory structure was completed an additional MAIN page was developed to assist with the navigation between the reports.

Before the CD-ROM was burned, we used Adobe Acrobat Catalog to create an index file of all the content within each of the documents. This allowed the reviewers to search for words and phrases within all of the documents that existed for the submission.