Sii Poland
SII UKRAINE
SII SWEDEN
Sii Poland
SII UKRAINE
SII SWEDEN
Sii will help you with validation processes in the medical sector – based on the requirements of FDA 21 CFR part 11, EU GMP Annex 11: Computerised Systems, MHRA GxP Data Integrity, GDPR and ISO 13485 in accordance with industry regulations.
We take full responsibility for planning and implementing validation projects in accordance with the CSV or CSA model and guidelines. We provide advice and support during the preparation of SRA (System Risk Assessment) and in the creation and classification of critical data DCR (Data Classification Report). We also provide comprehensive support to project teams in identifying threats and conducting FRA (Functional Risk Assessment) in accordance with the FMEA (Failure Mode and Effects Analysis) method. We conduct validation projects for systems delivered in classic models (Waterfall/Model-V) as well as based on agile methodologies.
At Sii, we provide consulting in defining and improving processes and validation strategies in critical areas in accordance with GxP. Depending on the client's needs, we provide validation projects based on the classic CSV (Computerized System Validation) or CSA (Computerized System Assurance) model, as well as support and consulting in the field of classification and qualification of devices and software for medical devices based on ISO 13485 requirements, and infrastructure qualification, including virtual networks and IaaS, PaaS, SaaS models.
We support our clients in maintaining validated status by supervising the implementation of changes in accordance with implemented quality assurance procedures and processes. We provide professional advice and support during the Software Vendor Audit, as well as representing stakeholders during QA/QC audits and inspections.
Sii experts provide comprehensive consulting in the field of defining and implementing validation procedures and process improvements based on GAMP5. Our data integrity strategies are compliant with MHRA and FDA guidelines, and we help in conducting risk analyses based on the FEMA method, taking into account functional and non-functional requirements. In addition to planning and implementing changes, Sii specialists provide technical presentations and training in the field of good documentation practices.
Sii experts support clients in planning, documenting and optimizing validation processes in accordance with GAMP 5 guidelines, including updates included in GAMP 5 Second Edition. In addition to strategic technical consulting, we offer:
Our goal is to ensure that all client teams are properly prepared, aware of the requirements and ready to operate in a regulated environment.
We will make sure that your production lines and storage systems are compliant with GMP and GxP requirements. Sii specialists conduct qualification and classification of devices intended for the production of medical devices, and in order to provide reliable evidence, they conduct a series of tests based on the applicable formal and legal regulations included in the FDA.
Over 15 years in the pharmaceutical market has allowed us to collaborate with major organizations like Bayer and Galderma. Our familiarity with FDA, MHRA, and local regulations like the German Arzneimittelgesetz (AMG) means Sii effectively mitigates compliance risks and speeds up your releases.
Sii is certified to ISO 13485 for quality management of medical software, ISO 9001 for comprehensive quality standards, and ISO/IEC 27001 for information security. These certifications demonstrate our commitment to consistent, high-quality processes. They also strengthen our ability to handle CSV projects in accordance with the highest international standards and the most demanding industry regulations.
We tailor our validation approach to your specific business context – whether you need advanced test automation, specialized hardware security, or full environment qualification. By consolidating development, testing, and validation efforts into one trusted provider, you gain efficiency, reduce overhead, and maintain data integrity across your entire environment.
Read out FAQ
Standard tests verify functionality, but CSV ensures systems comply with regulatory requirements such as GAMP5 and 21 CFR part 11 by emphasizing risk-based analysis, data integrity, and precise documentation. This deeper approach stops minor technical errors from turning into major compliance violations.
SRA and FRA analysis are essential elements that directly translate into the detection of potential risks, threats, and critical areas for an organization’s IT systems, including hardware, software, networks, and data management processes.
Agile GxP validation is entirely feasible. We coordinate each sprint so that key CSV documentation is updated incrementally. This method provides faster feedback and helps catch errors faster, while meeting the stringent data integrity requirements set by global authorities.
We consider IaaS, PaaS or SaaS models and assess their compliance with GAMP guidelines and regional data privacy regulations such as GDPR or HIPAA. The same principles of risk assessment, solid documentation and consistent testing apply – just adapted to cloud environments.
Subject to decommissioning in accordance with regulatory behavior – the system is removed or replaced by a newer system or equivalent – data is archived for a period defined in the regulation depending on criticality. Financial data at least 5 years, personal data from 10 to 50 years.
We create the necessary documentation to confirm that data, processes, systems, or activities meet specified requirements and standards. This thorough documentation demonstrates transparency, compliance, and certifies to auditors that the environment meets regulatory requirements such as 21 CFR part 11.
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