Our validation specialists have vast industry experience and will help to assure correct and consistent system operation while maintaining quality processes. We know you rely on professional integrity to provide you the very best solutions possible. In doing so, Complete Inspection Systems offers complete validation packages with on-site and remote technical support.
IQ Execution – The Installation Qualification (IQ) execution services may be conducted either remotely or at your site. In both executions, our consultants will lead your personnel in both hardware and software checks to ensure it meets the necessary requirements for systems operation.
OQ Execution – The Operational Qualification (OQ) execution services are conducted using Complete Inspection Systems, Inc.’s industry standard-based protocols to test and execute the various functions and operational features of our applications. Our consultants will directly assists your personnel in the completion of the protocol test activities throughout the OQ process. Upon test completion, the finished protocols and test execution notes are collected and become the objective evidence of the system performing to the functional design.
PQ Execution – The Performance Qualification (PQ) execution services include a customized PQ protocol detailing your baseline systems usage. Our consultants assist in the execution of the protocol test instructions, providing overall guidance and leadership during the implementation to ensure proper records and testing compliance.
Installation and Operational Qualification Protocols
Complete Inspection Systems Inc. has developed predefined protocols covering all aspects of the Installation and Operational Qualification requirements based on industry standard formats. The IQ/OQ protocols allow the manual execution of validation efforts in just a few weeks versus the lengthy task of program engineering review and self-creation of protocols that an off-the shelf or homegrown system would require.
Validation Best Practices
Some of Complete Inspection Systems, Inc.’s customers prefer to execute our protocols and validate products independently. If this is your preference, CIS’s Validation Best Practices consulting team will assist you with the organization of your Validation project, filling in the gaps to ensure a smooth execution and successful implementation.
Validation Solutions and Custom Protocol Development
Our consultants can assist you in the complete development of customized Performance Qualification protocols. Consultants begin the development process through the collection of the onsite configuration and usage procedures/work instructions for our applications. The data collected will then be used to create a baseline protocol that covers Data Integrity, Security Integrity and Electronic Approval Integrity testing from processes covering record creation, approval and secure retrieval. Testing supports multiple sites and users performing simultaneous operations, proving both system stability and overall usage integrity. This service is normally contracted as a part of the PQ Execution process, providing a full Performance Qualification solution.