Validation Services

Are you a pharmaceutical manufacturer presented with the challenge to validating methods for measuring cell density and viability, in accordance with regulations such as "cGMP"?

Your procedures depend on reliable information being provided by your suppliers. You are expected to arrive at an optimal cost-value ratio for validation and you require synergy effects through competent suppliers to achieve this. And last but not least you want to achieve the state-of-the-art in your line of business.

As a supplier of cell culturing monitoring systems for research and manufacturing processes, we are of the opinion that validation is not only a expensive legal restraint for pharmaceutical manufacturers but also an indispensable responsibility for all pharmaceutical manufacturers:

Therefore we see our continuous obligation in supporting you in your validation process using the most recent available information and providing you with efficient tools and demandoriented on-the-spot support. We see ourselves as a partner achieving a common purpose together with you: an efficient, lasting and, from a regulatory and business point of view, optimal validation! Our long-standing experience in supporting regularized process environments offers you helpful suggestions for further steps, for example in process validation as well as related problems and operation of your equipment after a successful process validation. We are equally familiar with topics such as calibration and maintenance schemes, as with processing and eliminating deviations.

Our service includes the following stages:

• Combined assessment of requirement (based on an Innovatis questionnaire of validation)
• Planning of the validation project and the required means
• Professional on-the-spot support
  • customization of documents
  • realization of IQ and OQ
  • expert advice for PQ
• Conclusion of the project and success monitoring

Since 2001, we have supported more than 20 qualifications for our customers in North America, Europe and Asia Pacific, providing on-the-spot support service including optimized documents for this purpose.

Would you like to learn more about our "validation service"?

Please contact validationservice@innovatis.com.