Computerized systems compliance — ISO 13485, EU GMP and lifecycle management
Are your computerized systems (ERP, LIMS, MES, EDM, QMS software) truly under regulatory control? This training gives you the keys to structure, validate and maintain the compliance of your computerized systems in accordance with the requirements of ISO 13485 and EU GMP Annex 11, covering the entire lifecycle: from initial qualification to decommissioning. A practical training, grounded in the operational realities of medical device manufacturers and distributors.
Audience IT managers, QA engineers, validation project managers, information systems managers in a medical device environment.
Learning objectives
- ▸ Identify and map the computerized systems subject to the requirements of ISO 13485 (§ 4.1.6) and EU GMP Annex 11 within their scope of activity.
- ▸ Distinguish the respective requirements of ISO 13485 and EU GMP Annex 11 and determine the applicable framework according to the regulatory context of their organization.
- ▸ Build a validation plan for a computerized system (IQ/OQ/PQ) by applying a risk-proportionate approach compliant with GAMP 5.
- ▸ Draft the key lifecycle documents of a computerized system: URS, functional specifications, test protocols, validation report, change management plan.
- ▸ Implement a change control and periodic revalidation process ensuring the maintenance of the validated state.
- ▸ Prepare and structure the documented evidence expected during an internal audit, a regulatory inspection or a notified body review.
Expected outcomes
- ✓ Ability to lead or actively contribute to a computerized system validation project in a medical device environment.
- ✓ Securing of the application portfolio and a defensible methodological rationale before an auditor or a notified body.
- ✓ Ready-to-use document templates: URS, validation plan, IQ/OQ/PQ protocols, change management plan.
Accessibility & entry conditions
Access lead time
Registration up to 10 working days before the start of an open-enrolment session. In-house sessions can be scheduled within 3 to 4 weeks.
Prerequisites
Basic knowledge of quality management systems (ISO 13485 or equivalent) or practical experience in a regulated medical device environment. No advanced IT prerequisites are required.
Disability access
Any disability situation can be accommodated. Contact our officer before registration to explore possible adjustments (equipment, materials, pacing). Contact our officer →
Funding
- ·OPCO (all sectors)
- ·Skills development plan
- ·CPF (subject to the course being listed)
- ·Company self-funding
Detailed programme
A phone interview or positioning questionnaire is sent ahead of the session to calibrate the level, identify expectations and tailor the case studies to participants' real situations.
- 01
Regulatory and normative framework for computerized systems (2h)
- ·Computerized systems in the medical device sector: stakes, definitions, scope
- ·Requirements of ISO 13485 § 4.1.6: scope of application and documentary obligations
- ·EU GMP Annex 11: principles, articulation with ISO 13485 and structural differences
- ·Overview of associated frameworks: GAMP 5, ISPE, ISO/TR 80002-2
- 02
Risk-based approach and classification of systems (2h)
- ·GAMP 5 categorization of computerized systems (categories 1 to 5)
- ·Risk analysis applied to information systems: methods and tools
- ·Determination of the required validation level according to the criticality of the system
- ·Practical workshop: classification exercise on real cases adapted to the participants' profiles
- 03
Validation lifecycle: from design to deployment (3h)
- ·Drafting the User Requirements Specifications (URS / functional specification)
- ·Functional and technical specifications: expected content and common mistakes
- ·Validation plan: structure, content, approval
- ·IQ / OQ / PQ protocols: design, execution, deviation management
- ·Validation report: what must it demonstrate?
- 04
Maintaining the validated state and lifecycle management (2h)
- ·Change control: process, impact assessment, revalidation
- ·Configuration management and version traceability
- ·Periodic reviews and revalidation criteria
- ·Decommissioning a system: archiving, data migration, evidence of compliance
- 05
Data integrity and audit trails (2h)
- ·ALCOA+ requirements in a medical device and GMP context
- ·Access controls, audit logs, electronic signature
- ·Management of electronic records: retention periods, secure archiving
- ·Practical cases of common findings raised during inspections
- 06
Synthesis, end-to-end case study and audit preparation (3h)
- ·End-to-end case study: validation of an ERP or LIMS in a medical device manufacturer context
- ·Reading an inspection report (483, CAPA, notified body findings) and critical analysis
- ·Questions and answers, field feedback, practical points of vigilance
Assessment of learning
Assessment methods
Final QCM of 20 questions covering all modules, administered at the end of the training · short role-play scenario: analysis of an incomplete validation scenario, with identification of shortcomings and proposals for correction (qualitatively assessed by the trainer). Training certificate issued by ISOFACADEMY subject to full attendance of both days. This certificate does not constitute an RNCP/RS certification; it attests to effective participation and to the assessment of acquired knowledge carried out as part of the training.
Certificate
A certificate of completion is issued to each participant, detailing the objectives, duration, learning assessed and the result of the final assessment. The document can be kept in a skills record.
Satisfaction and results
Satisfaction rate: Being measured
First learner survey campaign under way — data published once the statistical threshold is reached.
Training team
Training delivered by the ISOFAC ACADEMY teaching team, made up of consultants specialised in medical devices, quality and regulatory affairs. Depending on the module, the session is led by a specialist with hands-on operational expertise in MDR compliance, ISO 13485 quality management systems, ISO 14971 risk management, clinical evaluation, technical documentation, regulatory audits and CE marking strategy.
Our trainers support manufacturers, distributors, importers, authorised representatives and other economic operators on a daily basis in bringing their medical devices into compliance. See the team's profiles →
Technical resources
In-person
Room equipped at the client site or in a partner centre (Montpellier, Lyon, Paris). Video projector, flipchart, printed materials.
Remote
Zoom (corporate) platform for the virtual classroom. Materials provided in PDF + access to additional resources for 12 months after the session.
Learner equipment
A connected computer with camera and microphone for remote sessions. No software to install.
Post-course follow-up
Advice line
Hotline included for 30 days after the session for operational questions arising back on the job. Reply within 48 working hours.
Follow-up review
3-month review sent to the sponsor for in-house courses: feedback on the skills put into practice and any residual points.
Open-enrolment price (excl. VAT)
1 590 €
EU VAT applicable depending on the buyer's status.
In-house price
On request, depending on headcount and location.
Funding
- ·OPCO (all sectors)
- ·Skills development plan
- ·CPF (subject to the course being listed)
- ·Company self-funding
Personalised quote and OPCO funding application prepared within 48 hours.
Would you like to attend this course?
Tell us your preferred format (open-enrolment, in-house or virtual classroom), the number of participants and your schedule. We will get back to you within 48 hours with the next available dates and a firm quote.