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Validation

As a supplier to companies in the medical-, pharmaceutical- and the food industries our machines fully meet the requirements stipulated by the FDA. In this context, we have for a couple of years built up experience with the requirements stipulated by e.g. FDA in connection with validation of the production equipment. Typically we are responsible for the preparation of test plans for FAT, SAT, IQ, and OQ, and we quite often perform such tests as well. Many of the product models described in e.g. GAMP5 have become integrated elements of our day-to-day work.

We offer qualification and validation of production equipment from the start and till the machine is final installed with you. ProInvent’s machine productions include preparation of test plans for, and execution of FAT, SAT, IQ, and OQ. But we also deliver specifications, risk assessment and preparation and performance of test plans for URS, DQ and PQ.

Our expertise

  • High level of documentation
  • Project models with focus at specifications and tests, V-model
  • Process validation
  • Equipment validation
  • GMP validation
  • GMP risk assessment
  • Lean validation
  • FDA
  • Equipment qualification
  • Factory acceptance test
  • Version control
  • Site acceptance test
  • User requirement specification
  • Design qualification
  • Installation qualification
  • Operational qualification
  • Process qualification
  • GAMP5
  • 21 CFR Part 11

Risk Assessment 

Ensures: Correct coverage of potential risksEstablishes: Baseline for User Requirement Specification

IQ

Tests: Verification of correct equipment installation
Ensures: Correct specification of equipment
Establishes: Baseline for subsequent validation activities

DQ

Tests: Verification of correct equipment design
Ensures: Correct design of equipment per specs
Establishes: Equipment meets customers' demands

OQ

Tests: Verification of correct equipment operation
Ensures: Correct operation of equipment per specs
Verifies: Equipment operation meets claims from User Requirement Specification

URS

Ensures: Correct specification of equipment
Establishes: Baseline for subsequent validation activities

PQ

Tests: Verification of correct equipment performance
EnsuresCorrect performance of system per specs
VerifiesEquipment meets customers' intended purposes

"Our extensive experience in advanced technology development for a wide range of customers enables us to help our customers creating flexibility in the production environment by forming a validation strategy at an appropriate level".
Hashim Malik, Sales- and Project Manager

Learn more about validation

If you are interested in learning more about validation, Hashim Malik, Sales- and Project Manager of ProInvent, is ready to answer your questions.

Call Hashim Malik at mobile 30 60 12 42 or send him an e-mail at ham@proinvent.dk