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By Jakob Juul Rasmussen
March 2, 2021
By Jakob Juul Rasmussen
March 2, 2020
Should a vendor have been approved without auditing their IT validation of the used computerized systems, we recomend establishing a risk assessment. The risk assessment should define high-risk areas, for example data integrity or security, and seek to assess to which extent the vendor has mitigated and documented such risks. From here, audits and qualifications of specific high-risk areas can be conducted, in turn increasing chances of approval from outside auditors. Lower risk areas can then be handled later when high-risk issues have been identified and qualified.
According to EMA’s GCP guidelines, there are several cases in which you can rely on documentation supplied by your vendor. See the following list for a list of conditions in which sponsors may use vendor documentation2:
At Pharma IT, we are aware that conducting clinical trials is a complex process that involves expertise from a wide range of fields. For this reason, we have assembled a diverse, talented, and highly experienced team of Clinical Trials & Science Operations, Drug Development, CMC, and IT consultants. Feel free to contact us if you’re in need of assistance.
1. https://www.ema.europa.eu/en/human-regulatory/research-development/compliance/good-clinical-practice/qa-good-clinical-practice-gcp
2. GCP Matters, 9: https://www.ema.europa.eu/en/human-regulatory/research-development/compliance/good-clinical-practice/qa-good-clinical-practice-gcp
Jakob Juul Rasmussen is Managing Director of Pharma IT and has over 14 years of experience managing IT projects within Pharma, Finance, and the Public Sector.