Software Validation and eSignature (21 CFR Part-11 Compliant)
Our Approach to Validation
Staying compliant with 21 CFR Part 11 and the FDA's Computer Software Assurance (CSA) is easy with 1factory. We provide the essential documentation and tools to make your software validation process smooth and efficient.
Understanding Computer Software Assurance (CSA)
The FDA's recent guidance on CSA encourages a smarter, risk-based approach to validation, moving away from rigid, traditional validation. This means you focus your testing on the potential risks the software poses to product quality or patient safety.
The Four Key Requirements of FDA's CSA:
- Define Use: Clearly state how you will use the software (e.g., to record and store calibration data).
- Assess Risk: Consider the potential risks if the software were to fail (e.g., marking a faulty gauge as acceptable).
- Perform Testing: Select the testing method appropriate for the risk level:
- For low-risk functions, use flexible, exploratory (unscripted) testing.
- For high-risk functions, conduct formal, scripted testing. You can leverage 1factory's existing internal verification test case documentation.
- Keep Records: Document your testing and results to prove the software works as intended.
Validation is a Joint Effort: Your Role vs. Our Role
CSA is a joint effort. Your responsibility is Validation (ensuring the software meets your specific business needs). Our responsibility is Verification (ensuring the software meets its own technical requirements).
| Your Responsibility (Validation) | 1factory's Responsibility (Verification) |
|---|---|
| Define your high-level user requirements. | Conduct verification testing on new features and bug fixes. |
| Evaluate risk associated with using 1factory. | Provide evidence of all verification testing and results. |
| Develop and perform testing appropriate to the risks identified. | Make all verification evidence available to customers. |
| Document your testing and keep a report of the results. | Provide an updated verification package with each new release. |
We release a Verification Package (including user requirements, error checks, and a testing summary) after every Validated environment update. This helps you easily create your own CSA report and test scripts. Customers are hosted on a separate validated instance of the system.
1factory's verification test documentation includes detailed test cases with: User Requirements, Required Inputs, Error Checks, and Expected Outputs.
21 CFR Part 11 Compliance (Electronic Records and Signatures)
All of 1factory's Manufacturing (Manufacturing Inspection, Receiving Inspection, Gage Calibration, PPAP, etc.) and QMS modules meet the 21 CFR Part 11 requirements for electronic records.
Key Compliance Features:
- Role-based Access Control
- Version Control of Plans and Documents
- Change History for all Objects
- Traceability of Every Measurement (User Name, Date and Time)
- Electronic record protection to prevent unauthorized alteration and loss.
Electronic Signature Compliance:
With our e-signature option enabled, you can capture user signatures every time a unit of work is completed. Per FDA requirements, electronic signatures in 1factory are made up of two parts: a Username (A unique ID assigned to a user) and a Password (Known only to the user).
Each time a document is electronically signed, the system captures:
- The user's name and 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)
Additional Security Controls
- Password Requirements: Passwords must comply with NIST-800-171 requirements.
- Password Reuse Restrictions: Password reuse is restricted.
- User Time-Outs: Session time-outs force re-login after inactivity.
- Account Locks: Accounts are locked if incorrect passwords are entered too many times.
- Logging and Traceability: A log of every user action, including changes to Control Plans and edits to measurements (logged with User Name, Date, and Time Stamp).
1factory is here to help ensure a smooth validation process. If you have any questions, please contact us at support@1factory.com.