Reliable computer system validation (CSV)
Are you introducing software and need to validate it? Do you lack processes that enable conformity with regulatory requirements? Have you developed using the traditional V-model and now want to develop in an agile way and adapt your validation strategy?
Your path to validated software in medical technology and pharmaceuticals:
- We work with you to determine the applicable legal and normative requirements for your GxP-relevant IT systems and processes. These include EU EudraLex - Volume 4 - Good Manufacturing Practice (GMP) Guidelines, Annex 11 and 15, US FDA CFR - Code of Federal Regulations Title 21, Part 11, Part 210 and Part 211, ICH E6 (R2) Good clinical practice or ISO 13485.
- We take over the validation management and all necessary validation activities for the development of your computerized systems or we train you and your team so that you can do it yourself. To this end, we coach your validation officers, quality experts, but also entire scrum teams or development departments with regard to the various requirements for the design of development processes and the implementation of validation activities. We are closely aligned with GAMP 5 in order to successfully apply recognized best practices quickly and easily - especially in the pharmaceutical sector, but also in medical technology.
- In workshops, we work with you to design the optimum validation process from the initial project idea through to decommissioning in line with your existing framework conditions, development models, existing tools, document templates and processes.
- The use of agile frameworks such as Scrum is becoming increasingly popular in the regulated environment, especially in the VUCA world.To ensure that you can easily meet regulatory requirements despite agility, we have developed a framework for you that offers you a good basis for adapting to your needs and expectations with ready-made processes, document templates and SOPs.
Service portfolio IT Quality Services
Management of Validation
We plan, coordinate and document the successful validation of your computerized system - in any context. Do you already have clear specifications and document templates for this? Then we will of course use them. Are you missing individual templates or a documented process? No problem - we are experienced and will be happy to adapt our tried-and-tested templates to your computerized system. We reliably create the necessary documents such as the validation plan, validation inventory and validation report on time and support your team in creating other documents such as the traceability matrix.
We take the review of validation-relevant documents seriously so that you can be sure that the system documentation will pass an audit without any problems.
Implementation of Validation
Do you need support in carrying out validation activities? Are you planning a new development or further development of already validated systems or do you want to configure and validate purchased GxP-relevant systems (e.g. LIMS, pharmacovigilance, ERP), but you lack sufficiently qualified personnel? Our experienced validation team is looking forward to your challenges, whether on-premise or in the cloud, no/low-code, or AI / ML systems, we have the right experts for every application. We support you in the creation and review of your requirements documentation (whether requirements specification or user stories), we plan the necessary tests, especially at the system test and acceptance test levels, and carry out these tests for you. Of course, we also take care of the corresponding processing of deviations.
Strategies of Validation
Do you not yet have a strategy for validating your software and systems? We develop the optimal risk-based validation strategy and integrate it into your QMS. Based on the specific risks in your context and for your system, we moderate risk analyses and design your processes for requirements elicitation and requirements management - also in an agile environment. Important quality assurance activities such as reviews and test management are specifically tailored to your requirements. When designing the processes, we attach particular importance to ensuring that they are as lightweight as possible. It goes without saying that we take into account all regulatory requirements, such as electronic records and electronic signatures (ERES).
Regulatory Compliance
Do you already have validated software and want to ensure that the next audit ends without any defects? Would you like to check your suppliers for regulatory compliance? A first step is often the GAP analysis, in which we analyze all selected processes together with you or your supplier on site or in video conferences. We adhere to the principle of 'two sources of evidence', i.e. we listen carefully to what you tell us about your processes and we check your existing documentation. We then provide you with a detailed report and suggestions for measures to eliminate the weak points. We will be happy to conduct an improvement workshop with you to actively support you in achieving your goals. This way, you can look forward to external audits with confidence.
