Electronic Signatures within the HORIZON LIMS

Electronic signatures (eSignatures, e-signatures or eSigs) within the HORIZON LIMS/LIS comply with the FDA guidelines for electronic records and signatures (ERES) in Title 21 CFR Part 11 which defines the criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records (Title 21 CFR Part 11 Section 11.1) and EPA’s Cross-Media Electronic Reporting Rule (CROMERR).  CROMERR applies to and removes obstacles to submitting electronic documents to the EPA under Title 40 of the CFR. 

eSigs may turned off or on within HORIZON by a system administrator and are comprised of a combination of the user’s name, Login ID and password.  When electronic signatures are activated, steps cannot be marked as complete and moved forward without entering and authenticating a valid eSig.  eSigs may be used during login, transfer and sample disposal as required.  Chain of Custody (COC) eSig authentication may vary depending on the laboratory’s step by step flow with the COC process.  

Additional information electronic signature information may be found at:

https://www.fda.gov/industry/policiesguidance/important-information-about-digitalelectronic-signatures