Microtrac FLEX application software security features are designed to satisfy FDA 21CFR, Part 11 security requirements when all features are activated.
Those features include:
- Unique UserID and Password access to the application program for any number of users.
- User Pass word expiration
- Configurable User Groups
- Optional Provision for Requiring “Electronic Signatures” before all critical operations can be performed.
- Optional User Lockout in the event of a failed login attempt.
- Optional Application Lockout for all except an Administrator in the event of a failed login attempt.
- System administrator can Lock the application to all users.
- Options to Close and/or Lock the application if a period of inactivity (defined by the admin) has expired.
- Storage of “Electronic Signatures” (Unique UserID and UserPID) attached to measurement data in a secure database.
- Each measurement record maintains, displays and prints the following date and time information:
- Date & time of data acquisition
- Date & time of electronic signature
- Date & time of approval signature
- Date & time of recalculation
- Unalterable database measurement records
- Printed Reports with “Electronic Signatures” and references to Original Unaltered data (provides audit trail).
- Printed Reports indicate origin of the data and re-calculation* status.
- Measurement database is only compatible with Microtrac Application Software versions that support security.
- Measurement, Security and Configuration databases are Microsoft Access databases that are protected by “encryption” and a “password”. Microtrac databases cannot be opened or modified by any application except Microtrac FLEX software.
- Measurement database “secure records” remain so forever (unalterable).
- Database records CANNOT be DELETED when security is active or if the current record is a secure record.
- Parent / Child database record tracking.
- Option to require a new setzero (background) measurement for each sample measurement sequence.
Validation packages are available which include IQ/OQ documentation as well as Microtrac Reference Materials (Verification kits). Validation packages or individual verification kits can be purchased and used to verify/validate the performance of any Microtrac system produced over the past 20 years. Additionally, Microtrac has trained a network of Service Engineers who can be contracted to administer this validation testing anywhere in the world.