the GMP Electronic Notebook people

Our Markets

From the founding of the company, VelQuest has focused all of its efforts on the life science industry. Form late stage development to final product quality control and lot release, the SmartLab GMP Electronic Notebook System contains the necessary compliance requirements for cGMP operations. The system can be equally applied to ANY lab environment where rigorous adherence to approved test methods and standard operating procedures must be followed. From our founding in 1999, virtually all of our installations have been in pharmaceutical companies (large, small and generics) and supporting organizations such as contract research organizations (CROs).

Key to our success, is the operational benefits in taking a cGMP lab from a paper-based operation to paperless. Key issues include the following:

In VelQuest's paperless lab, all primary laboratory data and their compliance metadata are quickly and easily acquired in electronic form and stored in a secure, 21 CFR Part 11, cGMP-, GLP- compliant database.

  • Procedures are stored and accessed electronically, and are executed and documented in full compliance. Electronic Control Sheets, Test Methods and Standard Operating Procedures reside in a shared enterprise-wide database, so they are always current and consistent at all sites, anywhere around the world.
  • Redundant checking is replaced by at-a-glance "review by exception," where only the data that indicates audit trail or an out-of-limit condition need be reviewed. Because all necessary information is captured -- and instantly available in a relational structure -- reviews, approvals, investigations, audits and submissions are fast and painless.
  • Because there's always a ready, accurate and complete answer to the inevitable FDA question: "How do you know?" the risk of warning letters and citations is reduced.
  • Data available to other lab information systems are enhanced by additional, richer sources of laboratory data.
  • Not only does the lab operate more efficiently; errors are minimized because they can be flagged in real-time as a procedure is executed. Error prevention replaces the current mode of error detection.

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