(Sparta Systems: Holmdel, NJ) -- TrackWise SelectStart is a purpose-built quality management solution created specifically for small to medium-size companies across different segments of life science industries. These emerging companies have the same rigorous quality and regulatory requirements as multibillion dollar organizations but don’t have the same resources and budget. They face pressure to maintain the highest level of quality in every facet of their operations and must maintain compliance with a growing list of regulations, including:

• Title 21 CFR Part 11—“Electronic records and electronic signatures”

• ISO 9001—“Quality management systems—Requirements”

• ICH E8—“General considerations for clinical trials”

• Title 21 CFR Part 803—“Medical device reporting”

• Title 21 CFR Part 820—“Quality system regulation”

• ICH Q7A—“Good manufacturing practice for active pharmaceutical ingredients”

• ISO 13485—“Medical devices—Quality management systems—Requirements for regulatory purposes”

• ISO 14971—“Medical devices—Application of risk management to medical devices”

• Title 21 CFR Part 210—“Current good manufacturing practice in manufacturing, processing, packing, or holding of drugs; general”

• Title 21 CFR Part 211—“Current good manufacturing practice for finished pharmaceuticals” 

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