Validating a new system before go-live
You're implementing a platform that will hold GxP-relevant records. We define the validation strategy, run the qualification and hand over an approved documentation package your QA function can defend.
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IT and GxP compliance consulting for life sciences and other regulated industries. Computer system validation, audit readiness, quality systems and data integrity. We are committed to ensuring your effective and compliant use of technology.
InnovX is a consulting firm specializing in IT strategy and GxP compliance for regulated industries.
Our main focus is on the life sciences industry, but we serve food and beverage, general manufacturing and finance with our regulatory expertise. We deliver globally from Canada. We work in English and French, with Spanish- and Polish-speaking consultants available as needed.
Our services pillars are :
IT & GxP Compliance: Auditing and gap assessments, computer system validation and qualification, SOP and quality system development, compliance and validation training.
Operational Excellence: Business process management, organizational and project change management, program and project management, PMO setup, strategic and digitization planning.
Technical Services: Business analysis and system specifications, records and data migration, integrity and governance, system administration, vendor selection.
Frameworks we work in: FDA 21 CFR Part 11, 210/211 and 820 · GCP (ICH E6)· ISO 13485 · ISO 9001 · cGMP · Health Canada · EU GMP Annex 11 · EU MDR · ICH GCP · GAMP 5 · PIC/S · GDPR · Law 25 / PIPEDA
300+ projects delivered across 24+ countries. Boutique attention at a cost-effective footprint.
Use Cases
Migrating records off spreadsheets or a legacy system
Mapping, verification and reconciliation with a documented audit trail, so historical data stays complete and attributable after the move.
Preparing for an inspection or customer audit
Gap assessment against the frameworks that apply to you, a prioritised remediation plan, and mock audit support before the real one.
Selecting the system that fits your compliance obligations
We define your regulatory and operational requirements first, then evaluate vendors against them: RFP/RFI management, total cost of acquisition modelling and a business case. The output is a decision you can defend on compliance grounds, not only on price.
Documenting procedures
SOP creation, procedural structure and a roll-out strategy sized for your team, plus the training that makes it stick. Where a quality system already exists, we assess it and close the gaps rather than start over.
Training your team on quality and compliance
Specialized quality, compliance and validation training built on your own systems and procedures, not generic course material. Computer system validation and 21 CFR Part 11 are examples; we assess your gaps first and scope the training to them.