Lean Validation: Validation should be a critical process built into every regulated systems project. But how can you avoid project delays and overspending when it comes to validation? We help our clients determine the most appropriate level of validation based on industry best-practices and risk-based analyses.
Compliance that Fits: Every organization has their own unique approach to validation and compliance of computer systems. Unfortunately even the best designed quality systems have inconsistencies that can make planning a validation project difficult at best. We help clients make sense of the vast array of SOPs, Work Instructions, Templates, Guidances, etc. to design and implement a validation approach that works.
Execution: A validation plan is worthless without strong execution. How can you realize and prevent validation problems before they occur? Serac consultants are some of the most experienced validation consultants in the industry, and we bring our ability to flawlessly execute and delivery high-quality systems to every project we undertake.