Metrohm NIRS XDS SmartProbe Analyzer - Manual (Page 88)

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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