LabWare understands that verification or validation of a LIMS or ELN system has the potential to be costly and may be perceived as a regulatory exercise with no apparent value. LabWare Validation Services steers customers away from unnecessary, non-value adding activities and focuses on those compliance activities and deliverables that add value to the LIMS project. LabWare recognizes the fact that in the long run, over validation is difficult to sustain. LabWare consultants are certified both in LabWare applications and validation. Including validation consulting services early in the project leads to well defined requirements, clear objectives, potentially reduced testing scope, gains in efficiencies, reduced error rates and elimination of last minute changes.
The cornerstone to the validation effort is performance of the requirements risk assessment - involving regulatory, quality, and business impacts, hardware and software constraints, complexity, novelty, etc. It prioritizes and focuses efforts and activities on those areas that have the potential to pose the highest risk. Based upon this risk assessment, LabWare zeroes in on the most appropriate testing strategy for the identified risks. LabWare does not recommend, nor endorse retesting functionality that is leverageable and supported by documented testing by LabWare Validation Services team.
LabWare’s Goal Oriented LIMS Delivery (GOLD) methodology permeates all services offerings. The GOLD philosophy is evidenced in the validation services offerings where LabWare works hard to match the validation activities to the appropriate level for the client’s industry and internal compliance climate. The LabWare validation approach includes Education, Involvement, Mentorship and Self-sufficiency which parallels the GOLD phases. Be it from total education and leadership, through GOLD mentoring, to supplemental activities, LabWare Services provides the services where best needed.
In some cases, clients may already posses a solid validation methodology and require a different type of consulting. Leveraging a depth of validation experience, LabWare can deep dive into the particular need areas or supplement a client’s existing project staff. LabWare Validation Services Team is ready to provide the appropriate level of guidance, involvement and service required to satisfy the customer's regulatory and non-regulatory expectations.