Products > Environmental Monitoring Software > Validation

Validation

Optical Sciences EMS Systems are supplied fully validated using the GAMP4 project lifecycle approach. Documents will be written and tests will be executed at OSL Northampton and the customer’s site to demonstrate that the system has been fully installed and operates within pre-defined limits. The following documents will be written and executed:

  1. Functional Design Specification – OSL document issued and approved by customer.
  2. Factory Acceptance Test – Performed at OSL Northampton or Carlow and witnessed by customer.
  3. Installation Qualification (IQ) – Performed at the customer site after installation has been completed.
  4. Operational Qualification (OQ) – Performed at the customer site after successful      competition of IQ.

The validation documents will be written in MS Word in Optical Sciences format. The quotation does not include writing documents in customer required formats. The documents will be distilled into Adobe Acrobat for portability and to reduce the file size to be manageable.