Pharmaceutical Enterprise Systems & Solutions

Source: Verista

Our experienced subject matter experts validate and maintain your business and mission critical information systems, including Quality Management Systems, Enterprise Resource Planning, Customer Relationship Management Systems, Learning Management Systems, Document Management, and much more.

Your computer system validation initiatives can leverage our world class subject matter experts to skillfully validate and maintain your business and mission critical information systems.

  • Throughout the system lifecycle – from concept, planning, business process analysis, specification development, build/configuration, testing, production release, and operational change management -we develop procedures, assist with operational change and incident management activities, perform periodic reviews to ensure the system continues to operate in a validated state, and support re-validation efforts.
  • We partner with client stakeholders to identify system and data integration requirements, define specifications, and conduct verification activities to ensure the integration is performed to specifications.
  • We provide support throughout the data migration process, including analyzing legacy data, remediating data quality issues, preparing data migration plans / test plans, and conducting data verification activities.
  • Our team has extensive experience with Planning, Executing, and Managing Legacy Computer Validation and 21 CFR Part 11 / Annex 11 Gap Analysis and Remediation programs.
  • We can deliver Quality as a Service, an outsourced model delivering quality functions as an MSP (Managed Service Provider) model.