8 system validation – K-Patents PR-23 for K-Patents User Manual

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Complying with Documentation and Validation Regulations

6.8 System Validation

The system must be validated to prove that it complies with the technical requirements of
Part 11. The Installation Qualification, Operation Qualification, and Performance Qualification
(IQ/OQ/PQ) should also be performed.

6.9 K-Patents Refractometer System Adherence to

Part 11

It is not possible to supply a system “ready” compliant with Part 11. This is because the
requirements of Part 11 fall into two categories: those that are handled technically (through
software features), and those that are handled procedurally (such as through system
validation, SOPs, policies, etc.).

Part 11 applies to all computerized systems that create, modify, maintain, archive, or retrieve
records required by the FDA. K-Patents Pharma Refractometer generates electronic records
via Ethernet connection. These records can be stored as digital files and be printed out for
signature or filed and maintained as hard copies. The computer files are subject to Part 11
regulation. The instrument parameter and configuration changes also fall into this category.

These computer files may be used in either of two ways:

1. as a non-subject system by printing results, signing by hand, and maintaining

hard copies

2. as an electronic record-keeping system subject to Part 11 regulation.

Systems described by number 1 would be subject only to predicate rules, not Part 11.
Systems described by number 2 must comply with Part 11.

Please note: While K-Patents has taken account of the FDA Part 11 rules during
development of the Pharma Refractometer package and in the compilation of the
instructions and guidelines contained in this Instruction manual appendix, the system
described has not been approved or mandated by the FDA or any other government
agencies. So all compliance responsibility lies with the end user and K-Patents makes no
claims that the completion of all the procedures described here will exempt these companies
or individuals from FDA sanctions.