Metrohm NIRS XDS Transmission OptiProbe Analyzer - Manual (Page 82)

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9.2.3 Vision Validation Document Package
This Compact Disc (CD) contains full
documentation of the Vision Spectral Analysis
Software design process. This CD is available for
purchase through your Metrohm Distributor.
Documentation begins with the original Functional
Requirement Specification, Software Requirement
Specification, Architecture Documents, Code
Reviews, Test Results, Acceptance Tests, and other
important information.
At over 2000 pages, this CD will satisfy your Internal Audit Staff and external regulators that Vision
Software was designed from the first moment to be a fully code-validated, tested product for use in
the pharmaceutical industry. Documents were selected (from the enormous quantity of records in our
logs) based upon the patterns set during the many customer audits of our software development
process. Documents may be printed using Adobe Acrobat®, which is included on the CD for
download.
This CD is the most comprehensive, informative record of software validation anywhere in the
industry today. FOSS is also willing to host software audits (Upon agreed notice and terms) to those
customers wishing deeper information.
FOSS will host software audits by the FDA or other recognized regulatory bodies upon customer
request. Normal audit terms and scheduling policies will apply. Escrow agreements for source code
are available.
9.2.4 21 CFR Part 11 Compliance
Vision meets the strict requirements of 21 CFR (Code of Federal Regulations) Part 11, covering
Electronic Records and Signatures. Key compliance features include:
• Validation of system software and instrument connection
• Blocking of invalid or altered records
• Generates accurate and complete copies of records in human readable and electronic form
• Records protected and retrievable throughout their retention period, archive and backup
functions provided
• Limited system access to authorized individuals with unique User ID and Password
• Secure, computer-generated, time stamped audit trail that independently records the date
and time of operator entries/actions that create, modify, or delete electronic records
• Record changes shall not obscure previously recorded information
• Operational system checks to enforce permitted sequencing of steps and events, as
appropriate
• Use of device (e.g. terminal) checks to determine the validity of the source of data input or
operational instruction