Computer Systems Consulting

Drug Safety Consult can offer to audit the validation, use and maintenance of GxP computer systems in the field of pharmacovigilance and clinical development.

As a competent consultant partner Drug Safety Consult can facilitate user-friendly concepts for GxP regulated E-Systems with a robust, clear and focused structure for validation and maintenance.

Services include auditing of internal E-Systems and systems used at partners, vendors or hospital sites, support to establishing of validation packages and maintenance set-up via SOPs and standards.

When used for GxP regulated and business critical activities, GxP computer systems must be audited and must follow the requirements set forth by prevailing legislation in order to be viewed as reliable, and their data integrity as being preserved.

All personnel having a role or responsibility in the e-system must be trained and have knowledge on the requirements towards validated systems.

System compliance is impacted by global regulations for GCP, Pharmacovigilance GVP, and 21CFR part 11 for e-records and signatures.

Contact DSC here.

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View Dr. Lisbeth Tofte's handbook: A User's Guide to Computer Validation