BlueCielo EDM & ALIM technologies|Pharma & Biotech Industry|Pentagon Solutions

Tested and trusted out-of-the-box solutions that ensure compliance with FDA and cGMP regulations while delivering faster time to market and reduced risk.

COSTLY COMPLIANCE

Global competitors are continually looking for innovative ways to bring new products to market faster – but maintaining compliance in stringently regulated environments can cause delays which easily reduce profit margins. Companies in the pharmaceutical, biotechnology, and medical device industries cannot afford to risk their reputations or their license to operate, so must ensure compliance at all times.

STRINGENT REGULATION

FDA compliance requires that GMP documentation must be stored in a repository with specific security roles and process controls for auditing. However the systems offering electronic signatures, controlled access, controlled printing, audit trail and information assurance are not always suited to managing engineering information, and often do not facilitate easy communication with external contractors

BlueCielo offers regulated companies an out-of-the-box business solution that manages current Good Manufacturing Practices (cGMP) engineering documentation throughout the management of change lifecycle. By adding specific features to the core data management engine, our solutions help to minimize risk, ensure compliance, and avoid costly recalls.

IT’S POSSIBLE WITH BLUECIELO MERIDIAN:

LESS EFFORT

Provide a “single source of truth” to manage engineering information with all the necessary technical controls. Support compliance with health, safety, environmental and government regulations, including: FDA CFR Part 11, GXP and the European Annex 11 of the EU Guide. Improve document workflows and enhance the management of change process, delivering seamless information exchange – from maintenance to operations, contractor to owner operator, and/or supplier to maintenance.

MORE REWARD

Enforce automatic workflows to increase the efficiency of design, production, and maintenance operations, while managing engineering information throughout the organization to avoid information errors and costly recalls. Our industry template for the pharmaceutical, biotech and medical device industries can help you to bring products to market faster and reduces costly errors, increasing revenue and subsequent profits. Get return on your investment in just 30 days.

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