The medical industry is regulated by the US FDA and international agencies, and is required to document that the facilities in which its products are manufactured conform to applicable quality standards. In the US these are known as cGMP or current Good Manufacturing Practices.
Microelectronics manufactures have products which are extremely sensitive to micro contamination and other process parameters and require rigorous facility and process qualifications to maximize quality output.
Within a regulated or contamination critical facility, operations are assessed for potential impact on final quality of the product, and critical systems are thoroughly inspected, tested and documented by conducting a Facility Qualification.
Equipment Qualification (IQ/OQ/PQ)
cGXP qualification of the following types of equipment is provided by Gerbig Engineering Validation Services:
- Stability Chambers
- Purified Water Systems
- Compressed Air and Gas Systems
Gerbig can provide cGMP mapping of humidity processes with up to 16 channels through a custom manufactured humidity sensor array.
User Requirement Specifications
Upfront definition of critical user requirements is key to successful, validatable project outcomes. Gerbig can work with team leaders to establish and document properly the URS.
Validation Master Plan
A formal outline of the validation approach, scope, and acceptance criteria including documentation and testing matrix and defined roles and responsibilities of each team member.