Compliance & Security

Working in the Pharmaceutical industry as well as other regulated industries, a variety of compliance a security demands, and requirements must be adhered to, ensuring a consistent and high quality of processes and products. Ensuring compliance requires focus and continuous attention, since potential findings in an audit could have a critical business impact, depending on the severity of the finding. It is therefore of the utmost importance to focus on Quality Assurance as well as validation of equipment, systems and processes. Whether you are establishing new process or developing/maintaining an existing one, INVIXO can support you with the right competencies to ensure high quality. Limited focus on testing and validation often results in projects being postponed, because errors are discovered at a late stage in the project. Our experts have extensive experience in the compliance and security area, so we can support your business to make the right decisions – at the right time. The services in compliance and security are delivered in accordance with our clients’ standards and the regulatory requirements including EU GMP, FDA, EMA, ISO, ICH, GAMP, ISPE and ISA 95.

IT Security

With the use of digital solutions growing all around the globe, the amount of attempted crime towards digital solutions also increases. Just a single breach of a company’s IT security could potentially result in large profit losses or leakage of confidential information, posing a serious threat to the company’s core business. These threats motivate a large focus on IT Security, to prevent attackers from breaching the security of the company and mitigating the potential risks if they do.

We assist in the implementation of IT Security improvements and compensating controls e.g. anti-virus protection support.

We offer assessment of the security setup, through our security risk analysis, followed by end-to-end IT Security protection projects, general security counseling, preventive actions, and recommendations.

We furthermore assist with assessing the likelihood and business impact of potential IT Security threats and help create a structured focus on which potential threats are the most critical to treat.

Data integrity & IT compliance

We offer solutions to manage data integrity regulatory requirements to operate in compliance with FDA 21 CFR Part 11; Electronic Records; Electronic Signatures, EU GMP Annex 11, EMA Data Integrity Guidance, ISPE Special Report: Data Integrity. Protecting and handling information including services e.g. Audit Trail Review Assessment and QA controls implementation.

Engineering compliance

We offer multiple engineering services from high level advisory services for construction, through retrofit to maintenance of buildings and equipment. We support our customers with process development and optimization as well as a range of services within Operational Technology such as BMS, MES, DCS (e.g. SattLine or Procos). For the company’s production facilities INVIXO can do an initial, as well as a continuous process and technology health check with detailed recommendations and a roadmap as input to management, the local technical staff as well as other decision makers.

Test

Thorough testing is the very basis of high quality. At INVIXO we therefore offer solutions to all types of test related tasks. INVIXO utilize industry best practice, but always use our customer’s individual needs as a base, to deliver recommendations for the specific testing approach and structure. We deliver test strategy, test plans, execution strategy, test process, test documentation, as well as reporting and evaluation. We aid with performance-, usability-, user tests, etc. We assist in developing demands, test cases, execution and review of test cases, depending on the customer needs.

Validation

We offer end-to-end validation support, machine & IT qualification, and Computer System validation services according to GAMP 5 standards. 

Quality Assurance

We help our customers with support for continuous improvement such as process optimization and SOP writing as well as support for the daily tasks like batch documentation, production support, non-conformities, in-process/material sampling and analysis. INVIXO also has extensive experience in internal and external compliance & Quality Assurance and our experienced, certified auditors can support you with strategizing, planning and execution of pre-audits and audits and inspections including the company’s suppliers.

Please contact Head of Compliance & Security, Kenneth Svindt Rosenhagen, at email kenneth.rosenhagen@invixo.com or phone +45 4020 3078 to hear more about our Compliance & Security services and how we can support your digital transformation.