ABSTRACT

In the context of computers, SLC documentation means records that provide information about development, configuration, operation and maintenance, from high-level design documents to end-user manuals. The computer system documentation covers the relevant steps of the lifecycle, related Standard Operating Procedures (SOPs), hardware, and the software (application and system). The complexity and amount of the documentation that are typically needed to support a validated computer system may vary from system to system depending on the regulated company validation strategies. Good documentation constitutes an essential part of the quality assurance system and is key to operating in compliance with the regulated environment. Protocols are documents prepared before conducting the software ­testing. Protocols commonly define test methods and for conduct of the study, and list acceptance. The fundamental element to use vendor documentation to support the manufacturing system verification, including the software controlling the manufacturing system, is an acceptable quality system by the vendor.