参照ISPE GAMP5 second version的描述和分级，自动灯检机属于四类。

验证方面，参照ISPE C&Q的要求评估执行IOQ和软件相关的测试。

对于PQ，为了证实灯检机的性能等于或优于人工目检，需要执行knapp测试。可参见USP1790 section6.3的要求。

USP 1790 section 6.3节选“Automated visual inspection (AVI) combines automated material handling of the containers with electronic sensing of

product appearance. Containers that do not meet pre-programmed acceptance criteria are automatically rejected by the
machine. Early machines performed inspection for particles and fill level, but manual or semi-automated inspection was required
for the container and closure system. Newer models have the capability to inspect all attributes of the containers, along with
the contents. As with MVI, machines often spin the containers to set particles in motion and make them easier to detect. Multiple
cameras are used to image various regions on the container in great detail. Each camera is coupled with unique lighting to
highlight specific defects in the region of interest. Light-field and dark-field lighting techniques offer the same benefits as white
and black backgrounds as discussed above, offering contrast for a full range of light- and dark-colored defects. A defect found
by any camera is tracked through the machine to allow accurate ejection by the reject system. These machines also offer detailed
reporting of defects observed in a specific production lot.
AVI offers advantages in the areas of throughput and consistency, compared with MVI (4). AVI may also offer enhanced
sensitivity for some defects, compared with MVI, but may suffer from higher false rejection rates due to the inability to tolerate
normal variation in containers or product. This is especially true for molded glass containers and flexible bags.
Validation of the automated inspection equipment should be based on comparison with the compendial manual inspection
process with an expectation that alternative inspection methods demonstrate equivalent or better performance. Significant
effort is required to program these systems and to test their performance against a range of known defects, as well as acceptable
containers.”

看一下我列举的分类的描述（description）和举例部分，不用看具体的厂家，功能上都差不多，没用过北京乐码，但是都差不多，可以看下分类相应的对应起来就行。

四类：软件复杂，代码不开放，可以通过输入一些参数达到相应的功能。

为什么归于4类呢？北京乐码的自动灯检机属于几类