Ensuring that a newly rebuilt plant or installed equipment functions correctly and meets the necessary quality standards is of the utmost importance for all industries and businesses, but perhaps especially so for highly regulated industries such as Life Science and Energy. Carrying out this part of a project effectively and correctly can be the difference between success and failure.
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Commissioning, Qualification and Validation (CQV)
More and more manufacturing industries see the benefits of having a well-executed and structured validation process when delivering new and rebuilt facilities. Semcon has extensive experience in the Life Science industry and thus extensive experience in this type of work.
The steps to successful qualification in a GMP regulated industry
To succeed with a CQV process in a GMP regulated industry it is important to have both a good understanding of the facility, process or equipment to be qualified, while also having a thorough knowledge of current regulations, for example GMP, GLP, GDP and GAMP. At Semcon, we have extensive experience in these areas and offer both individual expert services as well as provide responsibility for the entire CQV process from start to finish.
CQV plan and strategy
Do you need to work according to risk-based verification? Or just do all the testing yourself? We can help you create a smart and cost-effective strategy based on your circumstances. The foundation for an effective qualification process is laid in the strategy, here our senior experts can help you get on the right track from the start.
URS (User requirement specification)
A clear and sufficient set of requirements is both necessary and a prerequisite for downstream qualification work to proceed smoothly. Our experts can help with both cross-functional coordination among your experts as well as providing input to the design of testable requirements for both physical and digital solutions.
To ensure correctly structured design, as a first step we often develop a solution design qualification together with our customers. As businesses and their solutions become more digitized, a major focus area for us is computorized systems. By helping customers manage these design requirements, that are often difficult to interpret, implement, and test, we act to bridge the gap between the project and system/automation engineer to ease and accelerate qualification progress.
All requirements listed in the URS need to be verified. However, those that do not affect the product can advantageously be compiled in a so-called commissioning protocol (CP). An advantage of putting requirements in a CP is that testing and deviation handling can be simpler resulting in saving time. We at Semcon know our validation strategies and are used to issuing CP efficiently manage CQV projects.
Installation Qualification (IQ) protocols
All installation requirements that affect the product (GMP-classified) are verified in an IQ protocol. We issue the protocol, coordinate testing, conduct deviation investigations within the qualification and then report the outcome of the testing.
Operational Qualification (OQ) protocols
All functional requirements that affect the product (GMP-classified) are verified in an OQ protocol. We issue the protocol, coordinate testing, conduct deviation investigations within the qualification and then report the outcome of the testing.
Performance Qualification (PQ) protocols
A PQ must ensure that equipment can operate within a specified process window. Requirements concerning the performance and process of the equipment are verified in a PQ to ensure that the equipment has a reproducible process. We issue the protocol, coordinate testing, run deviation investigations and then report the outcome of the testing.
Coordinate CQV resources and project lead the CQV Group
By choosing Semcon as your partner for a CQV team, you gain flexibility when schedules, cost estimates and work distribution need to be adjusted when your qualification projects face unpredictable challenges. By choosing a CQV team from Semcon, you gain the full value of Semcon's many years of experience. In these project constellations, we always assign one of our very senior validation managers/sub-project managers to lead the work to structure timeframes to optimize progress and to bring in the right people to avoid resource re-assignment, re-training, and associated delays.
When managing CQV activities, one or more additional services may be needed.
Decommissioning is what our customers often refer to as "reverse qualification". Within GMP-controlled operations, the disposal of equipment entails a great deal of work to ensure that connected systems and documentation are deregistered. Our consultants have extensive experience in this field.
Change control(s) matters. All changes within controlled environments require management on a case-by-case evaluation process. We can assist with issuing/supporting CC workflows, GMP risk assessments, as well as change coordination ensuring CQV and project activities linked to changes are properly reported.
Update SOPs. A well-written SOPs is vital tool to an employee’s daily work and can lead to improved accuracy, safety, and reduce delays resulting from the need for deviation management. Updating SOPs and issuing new SOPs are tasks we often assist with. Knowing how to gather information from a client’s experts and other key sources to carry out SOP updates is a strength our consultants possess. Putting these skills to work we know how to secure the approved qualification documentation.