Quality and Compliance Strategies to help organizations embrace Emerging Technologies (AI, ML, Journey to Cloud, RPA Bots etc), Maturity level assessments, Points of View and Whitepapers
2. Validation Services
Create Validation and Qualification Plans and Summary Reports, Perform Assessments (Part 11, Annex 11, Risk Assessments), Author and Execute Validation scripts (IQ, OQ, PQ), Document SOPs and Work Instructions.
Define IT Quality Management Policies, Procedures and Guidelines.
5. Periodic Reviews
Provide Periodic Reviews as a Service (Maintain System Inventory, Periodic review calendars, Notifications, Gather supporting data and evidence for various control elements, facilitate reviews, generate periodic review reports and Track actions)
6. Validation & Testing Services
Manage end to end Validation and Testing Life Cycle for one or more projects and operate as a shared service as applicable, Define and Manage SLAs/KPIs, Create and implement Test Automation strategies, Qualify Testing Tools
7. Infra Qualification
Define Procedures for Infrastructure Qualification, Manage End to End Qualification projects (Assessments, Vendor Qualification, Qualification Plans and Summary Reports, Risk assessments, Qualifying automated provisioning and other automated operations)
8. Legacy Remediation
Provide Compliance Remediation strategies for Legacy systems, Perform Impact Assessments, Execute Remediation plans and Document Summary Reports.
9. Others
Technical Writing Services, Document Management Services, Training Services for Regulatory Compliance and Computer System Validation