Software Validation and eSignature (21 CFR Part-11 Compliant)

1. Software Validation

1factory provides a number of powerful features to support computer systems validation requirements. These include:

  • Role-based Access Control
  • Version Control of Plans
  • Change History for all Objects
  • Traceability of Every Measurement (User Name, Date and Time)

1factory performs verification testing on the system, and provides documentation to help customers with their validation testing (validation scripts).

1factory's verification test documentation includes detailed test cases with:

  • User Requirements
  • Required Inputs
  • Error Checks
  • Expected Outputs

Customers that require validation are hosted on a separate validated instance of the system. For every new release, 1factory provides an updated validation package.

2. Electronic Signatures (Part 11 Compliance)

With e-signature option enabled, you can capture user signatures every time a unit of work is completed. For each signing, 1factory captures:

  • The user's name
  • Digital signature
  • Date and time of signing
  • The meaning associated with the signing (e.g. the release of an Inspection Plan, or the Acceptance of a Lot)

Electronic signatures in 1factory are made up of two parts:

  • A Username (A unique ID assigned to a user)
  • A Password (Known only to the user).

We provide a number of additional controls to support electronic signatures. These include:

  • Password Requirements: Passwords must comply with NIST-800-171 requirements.
  • Password Reuse Restrictions: Password reuse is restricted for a certain number of generations.
  • User Time-Outs: Session time-outs force a user to log back into the system after a period of inactivity.
  • Account Locks: Accounts are locked if incorrect passwords are entered more than a defined number of times.
  • Logging and Traceability: A log of every user action in the system. For example, the 1factory system logs every change to a Control Plan in the Plan History. Similarly, every single measurement, and any edits to those measurements are logged along with User Name, Date, and Time Stamp.