Services

Our competitive advantage is an unmatched ability to work side-by-side with our customers to determine practical solutions through a multi-step process. First, we work with you, uncovering areas of potential risk. After identifying areas of concern, we work in conjunction with your team to verify our findings. Once the findings are substantiated, we make recommendations and develop realistic action plans that fit your facility and personnel. After the initiatives are approved, we proceed with implementation and reporting. Your investment is invaluable because it significantly reduces the risks and burgeoning costs of non-compliance.

Validation

We define the scope of the project together. From our initial consultation, we’ll clearly define our role and the roles of those within your facility. From project launch to completion, we’ll guide you through the process with cost-effective, sensible solutions that meet your regulatory and strategic business needs.

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Here are some of the validation services we offer:

FDA citation and warning letter response
Third-party GMP, GLP and gap analysis audits
Data integrity remediation
Project management
Quality systems development and implementation
21 CFR Part 11, electronic records/electronic signature compliance
Facility, utility, equipment, process, computer, software and analytical methods validation
Validation training
Protocols and procedures development
Calibration services
Change control development and implementation
Environmental equipment mapping