Validation

EG Life Sciences supplies experienced validation resources to support our clients' validation projects. We provide both Validation Consultants to do the higher-level planning and strategy, as well as Validation Contractors to do the hands-on work. These experts use a risk-based approach and methodology to validate only what needs to be in order to ensure product quality


 
Master Validation Plan (MVP) Development

Establish and document plans for how, who and when validation activities shall be executed.

 
Process Validation (IQ, OQ, PQ)

Protocol development to show processes have been appropriately validated.

 
Equipment Qualification

Qualification of production and process equipment.

 
Cleaning and Sterilization Validation (ex. – SIP, Autoclave, ETO, Gamma, etc.)

Validation of methods to clean and sterilize product and materials.

 
Systems and Software (i.e. - 21 CFR part 11, electronic records, etc.)

Validation of software and systems to comply with applicable regulatory requirements.

 
Packaging/Storage Stability and Labeling

Establish documentation to perform downstream final product release and shipment.

 
Test Method and Assay Validation

Protocol development and execution to provide objective evidence of method and formula validation.