Managed Services

Quality Support Packages

AgosIT’s quality support package offers peace of mind in times of heavy workload. AgosIT can support your business with its QA support functions to allow your quality team to focus all their effort on patient Safety, product quality and data integrity. Our service provides instant quality support when it’s needed without the associated cost of employing extra resource.

The Quality Support Package provides the following benefits;

  • Document reviews, change management, risk analysis, RCA, deviation investigations and test management support.
  • Document reviews include initial or final review of SOPs, WI, Policies and executables for compliance with applicable regulations.
  • Assistance with change management and impact assessments, external quality representation for change board.
  • Assistance with risk analysis and risk profiling including remediation and scoring.
  • Support for deviation investigation and root cause analysis including deviation write up or approvals.
  • Oversight and management of testing activities during validation or qualification projects. Including support with incident and deviation management if required.
  • General QA support.

*For pricing in your local currency please contact us, prices will be subject to the prevailing exchange rate at time of invoice.
For additional hours please contact us for a bespoke quote.

System Management Support Packages

AgosIT’s system management support service provides an all-encompassing GxP admin service for your IT systems. This allows your IT and technical department to focus on what matters and not the day to day administration of the GxP systems.

The System Management Support package comes with the following benefits;

  • Includes GxP system admin, access control, workflow management, task reassignment, access reviews and periodic reviews support.
  • GxP system admin function covers administration and upkeep of core system functions requiring admin level access.
  • Access control includes management of user access including the Joiners, Movers and Leavers process for IT systems.
  • Management and smooth running of system workflows ensuring continuity of business workflows within the system including task reassignment and delegation of authority when users are unavailable.
  • Quarterly access report and admin audit trail report. Assistance with definition of access roles ensuring DI compliance and segregation of duties.
  • Support with access requests and access reviews for the purposes of periodic system reviews.

*For pricing in your local currency please contact us, prices will be subject to the prevailing exchange rate at time of invoice.
For additional hours please contact us for a bespoke quote.


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