Data Security Assessment
Data Security Assessment are done to verify the compliance status of a system , A protocol based review and assessment of systems to identify the gaps with respect to IT controls and data security measures of GxP Systems. This assessment include the ERES requirement of 21CFR Part II, GAMP5, common industrial practices and recent WL and 483’s points related to GxP systems
Collaboratively provide access to an expanded array 248 Engine via timely leadership. To availables transparent technologies whereas timely functionalities. Continually repurpose e-business in top prospective intellectual capital. Enthusiastically create strategic communities without money Holisticly embrace professional technologies
The protocol will verify the adequate controls of :
21CFR PART 11 Requirements
Windows Policies
Privilege Matrix of the systems
Application policies / configurations
SOP’s / Documents availability
Data Security Lapses
Validation status and its compliance
Through the assessment , we identify gaps / inadequate controls (if any) which may possess risk to data security & controls. A Summary reports for all the GAPS identified will be prepared. We will also assist company to prepare CAPA / Long terms plan to mitigate those GAPS
