123Compliance

123Compliance, founded in 2012 by Plarent Ymeri and another former Allergan employee, established itself as a provider of cloud-based quality and compliance solutions for the life sciences sector. The company's trajectory includes a significant milestone on April 10, 2015, when it secured $150,000 in a venture debt round from Lighter Capital. This culminated in its acquisition by Sparta Systems in January 2016, a strategic move to integrate 123Compliance's cloud-native platform with Sparta's established enterprise quality management software (EQMS).

The firm specializes in offering a suite of software solutions to small and mid-sized pharmaceutical and medical device companies. Its business centers on a cloud-based, mobile-enabled platform built on Salesforce, providing tools for quality management, complaint handling, and regulatory reporting. The platform is designed to be fully validated and compliant with 21 CFR Part 11, a critical FDA regulation, thereby helping clients maintain compliance throughout a product's lifecycle. Revenue was generated through annual service agreements, with costs around $10,000 for small companies and $50,000 for medium-sized ones, while larger project budgets were determined individually.

The core offering manages the entire customer complaint lifecycle, from initial logging through investigation, root cause analysis, and final regulatory reporting. Following the acquisition by Sparta Systems, new functionalities were added, such as product registration tracking to help manage submissions with global regulatory agencies. This integration aimed to create a 'Quality Business Network,' connecting manufacturers, suppliers, and distributors within a single digital ecosystem to enhance transparency and collaboration across the supply chain. The acquisition provided 123Compliance customers with access to Sparta's broader infrastructure and domain expertise, while Sparta leveraged 123Compliance's cloud technology to serve the SMB market and enhance its own cloud deployment capabilities.

Keywords: quality management system, QMS, regulatory compliance software, life sciences compliance, medical device compliance, pharmaceutical compliance, 21 CFR Part 11, complaint handling software, cloud-based QMS, Plarent Ymeri, Sparta Systems, document management system, regulatory reporting, Salesforce platform, adverse event reporting, quality business network, enterprise quality management software, EQMS, TrackWise