Regulatory

HACCP - Meet Hazard Analysis and Critical Control Points (HACCP) mandates with structured processes, operational discipline, and coordination. Leading processors turn to EnteGreat ‘ eHACCP solution which delivers best practices to enforce compliance in an efficient and practical manner.

Lean Batch Records - EnteGreat’s solution eliminates the cost and hassle of maintaining unnecessary content in the batch record and substantial waste in the overall batch record review and management process. This waste can be eliminated from batch records and significant business value unlocked by applying Lean principals. Using this approach, manufacturers in life sciences and other sectors reduce the size and complexity of Batch Records by 20 to 50 percent.

Electronic Batch Records – 21 CFR Part 11 Life sciences, medical device and other regulated industries must move away from paper (hard copy) methods to maintain records for FDA-compliance purposes. EnteGreat’s comprehensive solution helps you meet 21 CFR Part 11 FDA mandates. Track complete process information, meet mandates, simplify record keeping, and increase in-process control.

Compliant Manufacturing Framework - The ability to systematically enforce compliance within manufacturing operations offers tremendous business benefits. This approach helps eliminate waste and non-value added tasks while improving product quality, operational performance, and streamlining time to market. The Compliant Manufacturing Framework^® extends SAP to the shop floor to deliver MES / EBR functionality.