EAM for GMP Compliance
Product quality is always taken seriously in our industry, but we are now in a new era of higher GMP enforcement. Whether from FDA or international regulatory authorities, the bar has been raised for compliance.
New models for inspections, including Part 11 and Quality System Inspection Technique, are being implemented and companies not prepared are at risk of compliance deficiencies, product recalls, warnings and ultimately financial penalties and unwanted publicity.
At the same time, our industry is under tough financial constraints and cost cutting. With these opposing objectives, there has never been a better time for streamlining processes, automating work flow and improving record keeping to increase compliance.
Designed from the foundation up for GMP compliance, Blue Mountain Regulatory Asset Manager proven functionality is highly configurable, flexible and compliant. Blue Mountain RAM is uniquely suited to enable the highest GMP standards for calibration and maintenance, while being the most cost effective solution in the industry.
GMP Compliance with Blue Mountain RAM:
- Integrated Part 11 Work Flow with electronic signatures
- Best In Class GMP maintenance functionality
- Best In Class GMP calibration functionality
- Developed under GAMP 5 guidelines for software
- Robust security and database architecture
