Pharmaceutical Enterprise Systems & Solutions

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.