Information Systems
Mapping, auditing, implementation, and validation of information systems—Qualilab, an expert in information systems, adapts its practices and documentation to your specific context while ensuring compliance with applicable regulations and standards, always with a focus on maintaining data integrity.
OUR SERVICES
For many years, Qualilab has been helping clients secure and enhance the reliability of their information systems. This includes validating their systems to ensure compliance with various regulatory and normative requirements. From auditing your information system to implementing the resulting recommendations, Qualilab supports you at every stage to evaluate and optimize your system.
IT Activities
Our team brings its expertise in information systems to support you in:
- Setting up and maintaining reference frameworks and Quality Management Systems
- Auditing information systems, organizational structure, QMS (IT teams, suppliers, subcontractors, etc.)
- Process optimization and implementation of performance indicators
- Mapping computerized systems or data
- Project owner assistance: from drafting specifications to production rollout
- Preparing documentation/deliverables for projects or systems (quality plans, specifications, operational continuity files, architecture documentation, etc.)
- Design reviews
- Testing/qualification (FAT/SAT), creating validation kits for software vendors
- Project management
Validation and compliance of Information Systems
With extensive experience in computerized systems used in laboratories, we offer:
- Validation committee facilitation
- Drafting of Validation Master Plans and conducting global criticality assessments of systems
- Drafting of procedures: system validation, change control, periodic review
- Drafting of validation plans
- Risk analysis
- Drafting of protocols and test sheets (QC, IQ, OQ, PQ)
- Test execution
- Deviation management
- Drafting of qualification/validation reports
- Preparation for and participation in audits and inspections
- Supervision and tracking of changes
- Maintaining computerized systems in "VALIDATED" status
- Validation project management
- Our Qual.e.SI offering, dedicated to accredited laboratories and testing facilities
OUR TRAINING COURSEs
As a certified training organization, Qualilab offers training modules tailored to your context:
- 1Q6: Data integrity - Issues and controls
- 1Q8: ISO 17025 and ISO 15189 - Information System Management
- 4I1: Validation and compliance of Information Systems
- ...
Why choose Qualilab
For our proven experience and undeniable expertise. With knowledge in both management and technical areas, our multidisciplinary team can effectively assess your information system. Where necessary, Qualilab may also call upon independent experts—transparently—to complement or reinforce the internal team for specific challenges.
Our consultants are first and foremost field professionals, working directly with the IT departments of our clients. All our services are based on the most recognized frameworks and references, including: GAMP 5 (a risk-based approach to computerized system compliance under BPx), GMP Annex 11, FDA 21 CFR Part 11, PIC/S Guides, ICH Guidelines, ACDM/PSI Guides, OECD 17 (GLP Principles for Computerised Systems) and OECD 22 (GLP Data Integrity), CMMI (Capability Maturity Model Integration), ITIL, GAMP Guidelines, GEN-GTA-02 (Technical Accreditation Guide – Dematerialised Information Systems).
A team at your service
Our team is at your service to advise and support you in managing your Information System. Our consultants are available, if needed, to provide insights into the content of our services.
