The Validation Group (TVG)

Validations.com

GXP Validation Audits, Consulting and Training, supporting:

Comply with US FDA - WHO - EMeA - DEA - GMP - GLP - GCP - Title 21 CFR Part 11

Equipment

Software & Systems

Facilities

Device

Process

TVG has extensive experience within the FDA / EU regulated industries working under the various standards (cGMP, cGCP, cGLP, Systems) with one goal, to provide reliable Validation Consulting, Training, and Quality Assurance services that efficiently provide the assistance needed to help our clients succeed.

SMEs who understand your products, processes, systems and software and who recognize your applicability, and risks. Knowing how much validation is required is essential for a successful protocol development and audit.

Validation Law:

Complying with regulatory requirements directed by Federal Laws, Directives and International Regulations as required. Validation is a predicate rule. For U.S. Title 21 Code of Federal Regulation, see all applicable predicate rules.

Validation is “…confirmation by examination and provision of *objective evidence that a process, equipment, facilities, methods, software and/or hardware specifications conform to user needs and intended uses, and that the particular requirements implemented can be consistently fulfilled while discerning invalid data and results”

Validation Activities should be performed by person(s) who have the Education, Training, Background and Experience.

Validation should be performed by person(s) who understand the subject matter under validation.

Validation is the processes to discern invalid data.
Verification is confirmation of process action.

* "…confirmation by examination and provision of objective evidence"

Understanding ‘Objective Evidence’ is critical.

Unbiased. Not clouded by emotions, feelings or subjective objectivity.
Factual. Based upon:
- Engineering;
- Life Science;
- Physical Sciences;
- Statistical Data;
- Independent multiple qualified resources;