E-logbook cuts out wrist strain
for the drug industry that enables R&D teams and quality
control labs to maintain lab and GMP notebooks on computer
CT Consulting Group has developed PharmaLog, a new electronic logbook system for the pharmaceutical industry, which it says enables R&D teams and quality control laboratories to create and maintain lab and Good Manufacturing Practice notebooks on computer for the first time.
The intranet-based application utilises electronic signatures, multi-tiered privilege levels and time-stamped audit trails to ensure data integrity for legal and regulatory purposes, eliminating tampering risks that until now have forced pharma firms to maintain handwritten documentation of all lab and manufacturing work.
Developed in collaboration with major pharmaceutical companies, PharmaLog allows scientists and technicians to document required drug development and manufacturing information in electronic logbooks that are accessible to authorised users via password from any intranet-connected computer, according to CT Consulting. Electronic signatures are used to provide irrefutable identification of authors as well as date/time stamps that create a tamper-resistant audit trail.
All functions comply with the technical controls required by the US Food and Drug Administration's 21 CFR Part 11 rule for acceptance of electronic records and electronic signatures, it added.
"Lab and GMP notebooks are the last major area in the pharmaceutical world to resist automation, and the stumbling block has been the absence of strong security procedures that will ensure acceptance of data by legal and regulatory bodies," said Ron Harrison, president of CT Consulting. "PharmaLog finally breaks that logjam by incorporating FDA-approved security best practices into a complete electronic system built from the ground up for this purpose."
