KARMA LAB is specializing in implementing and performing prospective and retrospective validation protocols through well experienced team.
We use an efficient systematic approach to protocol development which allows for the preparation of the documentation in the shortest time possible. We also employ a pragmatic, common sense, approach to protocol execution which allows us to fulfill all regulatory requirements efficiently with a minimum of delay and with a minimum of interference with operations.
Installation Qualification Protocol
KARMA LAB can develop Installation Qualification Protocols for each critical utility or piece of equipment. The protocol provides for a systematic method of checking the static attributes of the equipment. The IQ will start with a description of the system. This description will describe what the system is intended to do, and all major components of the system. The system will be reviewed post-installation to verify that the system is as specified in the user requirement, detail design specifications, engineering drawings, data sheets, and manuals. As part of the IQ all such documentation will be identified and referenced.
“Equipment manufacturers can also use and execute our protocols as a Dry Run prior to shipping the equipment. This will accomplish two important goals. First, if something is wrong, the equipment manufacturer will discover it while the equipment is still under its full control at its site where all the resources and personnel are readily available to deal with the situation. Second, this will normally result in a shorter implementation time at the customer’s facility thus enabling them to put the equipment into production without undue delays.”
Operation Qualification Protocol
KARMA LAB can develop Operation Qualification Protocols to describe the operational and critical parameter testing required for proper operation of the system. Test objectives, methodologies, and acceptance criteria are defined and pre-approved. Prior to execution of the OQ all critical Instrumentation (calibrated instruments) will be identified and documented. All control inputs are manipulated and control over each variable demonstrated and compared to the pre-approved design/acceptance criteria.
“Equipment manufacturers can also use and execute our protocols as a Dry Run prior to shipping the equipment. This will accomplish two important goals. First, if something is wrong, the equipment manufacturer will discover it while the equipment is still under its full control at its site where all the resources and personnel are readily available to deal with the situation. Second, this will normally result in a shorter implementation time at the customer’s facility thus enabling them to put the equipment into production without undue delays.”
Performance Qualification Protocol
KARMA LAB can develop Performance Qualifications to validate a complete integrated process (e.g. a packaging line consisting of several pieces of equipment, Incubators, Sterilization Autoclaves, Depyrogenation Tunnels, Ovens, Cold Rooms, Freeze Dryers, etc… ). Performance Qualification Protocols test the performance and critical parameter testing for each individual piece of equipment on an integrated process. All set-up information is documented and samples are collected at the end of the integrated process based on ANSI/ASQC Z1.4-1993 general inspection levels and acceptance quality levels established by the end user.
“Equipment manufacturers can also use and execute our protocols as a Dry Run prior to shipping the equipment. This will accomplish two important goals. First, if something is wrong, the equipment manufacturer will discover it while the equipment is still under its full control at its site where all the resources and personnel are readily available to deal with the situation. Second, this will normally result in a shorter implementation time at the customer’s facility thus enabling them to put the equipment into production without undue delays.”
Computer System Validation
KARMA LAB will develop each of the various aspects of Computer System Validation. This includes System Life Cycle Methodology. Karma Lab is able to define, document and implement the process of documenting and testing all the various aspects of a computer based control system/process, from its inception through its design, build and installation, and all the way to its eventual decommissioning.
