Briefs

Group Backs FDA’s RFID Push

The Healthcare Distribution Management Association (HDMA) said earlier this month that it supports the FDA’s decision to lift the stay on the Prescription Drug Marketing Act (PDMA) final rule. By implementing the final rule on Dec. 1, the FDA is taking a step forward to further ensure patient safety, prescription drug integrity and supply chain security, HDMA said June 9.

HDMA in February called for the implementation of the pedigree provisions of the PDMA as an important interim measure to further improve supply-chain security and patient safety. But the pedigree provisions are just one part of a comprehensive anti-counterfeiting strategy that must involve manufacturers, distributors and pharmacies. HDMA supports the adoption of current and emerging track-and-trace technologies such as RFID.

“We have zero tolerance for criminals who counterfeit patient medicines, and we commend the FDA for moving forward with implementation of the PDMA final rule,” said HDMA President and CEO John Gray. “This is an important step in an ongoing, multi-layered battle plan to further secure the supply chain and protect patient safety.”

IBS America Unveils QSi Version 6.0

IBS America, a provider of compliance management solutions, announced the release of its newest version of its integrated client-server based compliance software, QSi System version 6.0, easing enterprise compliance with evolving occupational health and safety, quality, environmental and automotive quality mandates.

QSi System version 6.0 is designed as a client server solution using the IBM Lotus Notes Domino application server. The latest version of QSi includes integrated support for the newest QSi System module: Occupational Health and Safety Management (e.g., ISO 18001), building off additional modules for Quality Management (e.g., ISO 9000), Environmental Management (e.g., ISO 14000), Automotive Quality Management (e.g. TS 16949) and the FDA requirements of 21 CFR Part 11.

Version 6.0 features include extensive enhancements to the employee training suite and an improved user interface and consistent layouts that allow managers to easily view training requirements and monitor courses, certifications and qualifications of employees. It is also simple for trainers to schedule training classes and for employees to sign up for and acknowledge receipt of training, the company said in a June 12 announcement.

Octagon Wins Innovation Award

Octagon Research Solutions, a provider of services that improve esubmission efficiencies in clinical R&D, was awarded a “Stevie” for “Most Innovative Company” at the 2006 American Business Awards, the company said June 13. Octagon synchronizes processes and increases automation to reduce island-to-island inefficiencies within the clinical research and development process. Its services work to leverage the power of electronic submissions through cross-functional esubmissions expertise, a holistic process approach, deep domain knowledge and integrated solutions.