An FDA-Qualified Infrastructure
The FDA imposes strict data integrity requirements and lends no relief to legacy systems or large companies with several hundred to thousands of systems to validate. Pharmaceutical IT services have been a major pillar within pharma as demands have greatly increased as of late.
With COVID-19 taking the front headlines over the last 2 years, Pharma has been the driving force in getting the health of the country, and the economy back on track. Under increased pressure, your IT infrastructure must keep up with current and anticipated future demands.
Our expertise ranges from storage, backup and disaster recovery, to the implementation of security tools and policies that protect critical data. In all cases, our goal is to help companies achieve and maintain regulatory compliance as defined by 21 CFR Part II.
Enable an IT infrastructure to empower your goals.
Pharmaceutical IT Services built for your current and future demands.
Software systems used to store data relevant to FDA-regulated products or submissions must be documented, tested, and validated before they are put into production.
FDA-regulated computer systems should be installed in a logically separate network, segmented from the general business-computing environment at the site.
Strong Authentication and Data integrity will be required on any connection originating from outside of the regulated perimeter.
Backup and Recovery
The backup and recovery capability of the regulated systems is the single most important requirement of a secure infrastructure design. Offsite storage is required for FDA inspection. Tapes and backup media that are kept on-site should be secured and carefully controlled.