Report Generation

LCMS Report Assembly & Production

ALTA uses a highly automated report generation system complete with file tracking and version control for all of our final reports. The major advantage to this approach is threefold:

Ø Change control procedures are incorporated that meet regulatory requirements based on GLP and 21 CFR Part 11.

Ø File tracking and version control greatly reduces QA review time for the final reports.

Ø Project Managers and report production coordinators can process large amounts of data and produce final reports without the need to “cut and paste”.

A detailed description of ALTA’s “just-in-time” idealized report assembly process can be found below.

Prior To Publishing Data

Data is reviewed by Analysts and QC personnel and then submitted to Project Management.
Project Management reviews data for overall study compliance.
25% of raw data is reviewed by QA after Project Management review.
Database is locked, incrementally, as sets are reviewed and approved (ALIS Incremental Database Lockdown).

Publishing Tables From ALIS Into Excel Files

Each report table is published to a separate Excel file.
Rev-01 files are output into both write and read only directories.
Tables are formatted by report writers according to sponsor requirements (Creation of Rev-X).
Tables are logged into a read-only directory after QC review.
QA checks version Rev-01 in read-only directory against Rev-X for any data or annotation changes using document comparison software tools, which eliminates the need for redundant data review.

Publishing Final Tables to PDF and Table Locking

Tables are numbered and files are published to PDF (stamping output with version #).
PDF tables are merged using Adobe Acrobat (Version numbers included).

Preparation of Draft Report

Cover report (text) is prepared in Word.
Project Manager reviews cover report and all associated tables.
Cover report, tables and appendix files (all PDF) are assembled (merged) in Adobe Acrobat and paginated.
Report is reviewed by Project Manager and submitted to QC (Report Rev-01).
Report is logged into a read-only directory after final QC review.

Generation of Final QA Reviewed Report

QA reviews report (Report Rev-X) utilizing software comparison tools that detect any changes from the original report.
Final Report is logged into a read-only directory.
Report is released and filed in the archive.