Blood and Tissue

Good manufacturing practice (GMP) regulations Part 606, CLIA '88 requirements, increased regulations from the FDA for unlicensed blood establishments and transfusion services, competition within the blood banking profession, and increased cost pressures have changed the way the blood banking community conducts its business. In today's competitive environment, conducting business in a quality framework is no longer an option, but a must*.

Part of a quality assurance program includes maintaining and calibrating equipment and instruments, such as thermometers and centrifuges, and documenting those events to satisfy regulatory requirements.

Blue Mountain Regulatory Asset Manager is a browser-based solution for companies that are looking to improve collaboration across multiple groups involved with the management of assets. It combines all the unique features required by maintenance personnel, including work requests and inventory management, with all the features required by calibration personnel, including standards traceability and measurement data collection, in a single package that eliminates duplicated data entry on shared assets.

With everyone involved with the asset using the same application, notifications can be sent to all groups impacted by specific activity. This quick response can make a big difference in getting equipment back up and running quickly.The configurable approval routing system can even keep records from being used that have not been reviewed by the appropriate personnel.

Calibration Manager is the industry standard stand-alone Computerized Calibration Management System (CCMS). Designed for FDA regulated companies, the software allows you to track any type of equipment, schedule multiple events, and record measurement data information. You can also customize the software and manipulate the data to meet your facility's specific requirements. Calibration Manager has the best-in-class functionality, including Part 11 ER/ES, audit trail, custom security, and record archiving.

The state-of-the-art architecture of both Blue Mountain Regulatory Asset Manager and Calibration Manager, companies can install the software at one facility or for an entire organization.

A computerized system used in the manufacturing process must perform properly. Blue Mountain Quality Resources provides a complete Validation Protocol for all its products with the test scripts and guidelines to prove the effective functional use of the software. Blue Mountain also provides other validation resources, including a Software Quality Assurance Manual, training, and on-site validation.

*www.aabb.org - "Accreditation Program"