Spectra Manager™ CFR

21 CFR Part11 Requirements

• Electronic records and electronic signature
• Validation of Systems
• The ability to generate copies of records
• Protection of electronic records
• Limiting system access to authorized individuals
• Audit trail with time-stamp
• Use of authority checks

New Functions of Spectra Manager CFR

• Security manager
• Management of security information.
• Digital record of audit trail.
• Use of relational database.
• Validation of Systems
• Easy-to-use security information management.

Starting up Spectra Manager CFR

Startup window lists available resources (instruments, measurement programs and application programs).

Spectra Manager CFR

Access control for secure systems

Spectra Manager CFR - Secure Access

Spectra Manager CFR access requires Username and Password, assigned by the 'Workgroup' Manager.

Users - System Access

System access level determines access to Administrative Tools: Administrator, Power Users, Limited Users, and Users.

Use of Authority

Checks Firm Security of Spectra Manager CFR is established by its own security function as well as the Windows OS.

Spectra Manager CFR uses 2 systems of user classes.

• Access levels for the System group
• Administrators
• Power Users
• Users
• Operators
• Access levels for the Workgroup
• Managers
• Users
• Operators
  

Electronic Signatures

There are three levels of electronic signatures: Creation, Review, and Approval. Data files are always signed upon creation; i.e. spectral collection or data manipulation. Electronic signature also applied to Canvas templates or documents, instrument parameters and analysis methods (Quant, etc.)

Data File Audit Trails

Audit trail (History) is assigned to every data file, recording data manipulations on the spectral data.

Audit Trails

Instrument Parameters, Canvas Templates and Method Files.