R-019-001_Software validation report 22_001 AppFire
| Name | Classification | Provider company | Developer company |
|---|---|---|---|
| Appfire | Electronic signature | Appfire Technologies, LLC | Appfire Technologies, LLC |
Expected use
This software will be used to electronically sign QMS documentation.
Objective
This procedure has an objective to validate the software in accordance with its expected use.
Methodology
Initially, the software is validated with a general procedure; all applications will be subjected to this generic procedure. Then, depending on its type, the software will be subjected, or not, to additional tests detailed below:
- Executable file in path.
- Software execution.
- Absence of error messages.
- Operating system stability.
Acceptance criteria
The acceptance criteria for each identified test is described below. If the results are not exactly the same as the ones defined in the acceptance criteria, the validation will be rejected:
- Not applicable, it is a cloud-based application.
- The software runs satisfactory. The application can be integrated in the QMS system.
- Absence of error messages. Error messages do not appear nor it does not harm other programs in execution.
- No color changes in the monitor, no unjustified or unusual delays or any other hardware or software error associated with the start of the program. The computer does not slow down.
Verification matrix
| Test | Passed | Observations |
|---|---|---|
| Sotware execution | Yes | |
| Opening the application in several browsers | Yes | |
| Creating and editing a document | Yes | |
| Saving a document | Yes | |
| Signing a document | Yes | |
| Registering signature date | Yes |
Validation history
| Responsible | Date | Passed |
|---|---|---|
| Taig Mac Carthy | 15/10/2022 | Yes |
| Written by | Reviewed by | Approved by |
|---|---|---|
E-Signature (Appfire integration):  Taig Mac Carthy 6759627FEFF4185E59808AEA1237659D Signer name: Taig Mac Carthy Signing time: Wed, 12 Oct 2022 13:56:15 GMT Reason: Creation of document | E-Signature (Appfire integration): Alfonso Medela 23728E51DB3B53136F3F4C4F1E0F331D Signer name: Alfonso Medela Signing time: Fri, 14 Oct 2022 14:08:37 GMT Reason: Reviewed | E-Signature (Appfire integration): Andy Aguilar ED6F6C3CAA00A1C2CF2E06B9D0ADF5DC Signer name: Andy Aguilar Signing time: Sat, 15 Oct 2022 14:07:45 GMT Reason: Approving document |
| Quality manager (QM) | Technical manager (PRRC) | General manager (GM) |