"Validera fulfills the very high demands we place
on our consultants, both in terms of competency
and personal qualities.”

Said Diarbakerli, Regulatory Compliance Officer, AstraZeneca

AstraZeneca uses external consultants for many IT-related tasks. Validera has been, and is currently, a collaboration partner in the review and quality assurance of necessary system changes. The current consultancy role is as a Quality and Compliance officer. “All measures, both large and small, must be reported and managed according to our routines,” says Said Diarbakerli, Regulatory Compliance Officer at AstraZeneca.

Routines are very strict, but requirements vary depending on the system in question. The need for follow-up, control and documentation is assessed before each change. Changes made in other countries, but which affect the Swedish system, are also reviewed from a Swedish perspective.

”This role requires fine judgment. The result must be ”correct”, in so far as guaranteeing safety and quality, but at the same time it should not incur more time and costs than is necessary. In other words, the task requires the appraiser to use their knowledge and experience, concerning both regulations and how the systems work in practice.”

”We are very satisfied with Validera’s contribution, which has resulted in us continually extending our collaboration with them.”

Said Diarbakerli places great value on the fact that Validera’s consultants are self-reliant and are able to make the fine judgments that are necessary – both in the assessment of which measures are required and also in the interplay with those who are affected by system changes.

”The demands made must be fulfilled, but the people affected may sometimes feel that they are a hindrance. Therefore, it is extremely important that the person responsible for control and follow-up is able to stand behind, and explain, the requirement so that those involved are properly motivated to do things exactly right.”

”Whipping people into submission will not work. In this type of role we need unafraid but socially capable and unassuming personalities.”

About AstraZeneca
AstraZeneca is the world’s fifth largest pharmaceutical company and carries out research and development at 17 centers in 8 countries, manufacturing in 19 countries and sales in over 100 countries. In all, the company has 66,000 employees at different locations around the world, of which approximately 12,000 are in Sweden. Some important products/brand names: Crestor, Losec, Nexium, Symbicort and Seroquel.