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. 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.
9 of the 10 world's largest Pharmaceutical companies use BlueCielo solutions to maintain regulatory compliance
BlueCielo offers regulated companies an out-of-the-box business solution, which 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. That's why companies like Wyeth, Genzyme and Grifols choose BlueCielo software to maximize their profitability and reduce their risk.
Less effort, more reward
With BlueCielo solutions, you get a single source of truth to manage engineering information with all the necessary technical controls. Our software supports compliance with health, safety, environmental, and government regulations, including FDA CFR Part 11, GXP, and the European Annex 11 of the EU Guide. Our solutions improve document workflows and enhance the management of change process, delivering seamless information exchange from maintenance to operations, contractor to owner operator, and supplier to maintenance. BlueCielo Meridian software enforces 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 and can deliver a return on your investment in just 30 days.
What our customers say
"BlueCielo Meridian will take us to new levels of efficiency and compliance. The FDA Module provides the technical controls related to compliance with 21 CFR Part 11 necessary for our engineering drawings." - Genzyme
"BlueCielo Meridian and the FDA Module enabled us to easily meet our 21 CFR Part 11 and GMP regulatory requirements." - Wyeth
"Grifols has realized the anticipated efficiency gains in our capital projects and in streamlining information turnover between operations and maintenance. Additionally, BlueCielo's life sciences experience and quality-based implementation processes contributed to the successful system validation." - Grifols
How can BlueCielo Meridian help you?
Efficiency Enhance efficiency by integrating rendition in your business processes and avoid costly errors and recalls through improved communication.
Collaboration Improve communication with contractors and suppliers using exact security roles for authorized users with configurable process controls.
Security Protect your sensitive data during collaborative and concurrent projects with a central, secure repository for easy audits.
Profitability Reduce the total cost of ownership through decreased information management costs and leverage your existing system investments.
Regulatory compliance Deliver the technical controls for FDA 21 CFR Part 11. Control access, printing, eSignatures & eRecords for good laboratory practices (GLP), good clinical practices (GCP), and current good manufacturing practices (cGMP). Use computer system-validation templates to support GAMP 5.