Validation of computerized systems
Life Sciences Alliance
Validation of computerized systems (CSV) / software validation
Life Sciences Alliance and Computer Systems Validation (CSV).
Due to high regulatory requirements of the life sciences industry, computer systems that have an impact on product quality, patient safety or data integrity must be validated according to GxP guidelines and kept in a valid state during the entire system life cycle.
Within the Life Sciences Alliance, we have a team of experts who have been involved in the validation of a wide variety of computer systems for more than 25 years, such as ERP systems, document management systems (DMS), laboratory information and management systems (LIMS), manufacturing execution systems (MES), application lifecycle management (ALM), clinical trial systems, custom developments, spreadsheets, etc. We are your competent validation partner for all operating models of these systems (on-premise, cloud and hybrid systems).
COMPETENT VALIDATION PARTNER FOR ALL OPERATING MODELS
DOCUMENT MANAGEMENT SYSTEMS
LABORATORY INFORMATION & MANAGEMENT SYSTEMS
MANUFACTURING EXECUTION SYSTEM
APPLICATION LIFECYCLE MANAGEMENT
Our Best Practice Method
Through a multitude of projects at SMEs and international corporations, we have developed a scalable best practice method that enables software validation that is economical and tailored to your needs.
The best practice method is based on a process model and includes work instructions (SOPs), templates, training documents and tools. It covers the entire system lifecycle – from initial implementation, through the operational phase, to decommissioning and data archiving. We continuously update our methodology to include solutions for new regulatory and technological challenges (e.g. Machine Learning or Artificial Intelligence).
Life Sciences Alliance has an experienced team of CSV experts who will be happy to support you in your validation tasks.
Our consulting services and tools for the validation of computer-based systems
Our consultants will gladly and competently support you in the following topics:
- Fit-Gap or Inspection Readiness Analysis (Friendly Audits / Compliance Checks
- CSV Framework Check = Review of your validation framework and validation documentation for completeness and efficiency
- 21 CFR Part 11 & EU GMP Annex11 Assessments
- Data integrity assessment
- Development of remediation plans, e.g. adaptation of your risk-based validation strategy to new regulatory requirements
- Design of software validation strategy and framework incl. work instructions, templates and training material
- Software validation / compliance workshops
- Development of test strategies
- Development of data migration and data verification strategies
- Coaching of QA / validation managers
Our Validation Services include taking over all validation activities - from project management to document preparation - and include:
- Creation of validation strategy, plan and report
- Creation / review of life cycle documents
- Audit management
- Periodic review
- Change management / maintenance of valid status
- Training management
- test management
- Project Management
- Data migration and data verification strategies
- Supplier management, including audits of suppliers and service providers
- Technical writer: assumption of documentation tasks, e.g. creation of SOPs and test plans
With our "Managed Services for Validation", the effort and costs of IT compliance can be reduced and made transparent. Depending on the initial situation, we offer service packages in the area of Managed Validation Services that are specially tailored to your customer needs. These range from targeted support (Validation as a Service = VaaS) to a full service package.
Depending on the desired level of support, we provide the necessary compliance concept, methods and resources for achieving and maintaining IT compliance. In doing so, we draw on over 25 years of experience in this area.
We have now condensed our experience from many complex CSV projects into our IT Compliance Framework as good validation practice. At its core, this is a reference model for the design of computer system validation as part of IT quality management
The IT Compliance Framework includes:
- Reference processes as flowcharts with defined interfaces for the design and further development of your IT organization.
- SOPs for the GxP-compliant description of computer system validation that are aligned with the reference processes
- Important templates for implementing the processes in your company
Using our framework saves you time-consuming conceptual and editorial work. You will receive procedures reviewed by experts and proven in practice, as well as documents that will help you to optimize your IT quality management processes. We help you with the design or implementation and, if desired, also take over operational validation tasks during ongoing operation as a service.
To ensure efficient validation processes in the project, LSA provides a cloud-based validation platform via which validation documents and SOPs are digitally managed and controlled. In addition, SAP Solution Manager is used to provide the preconfigured and documented solution and to control the IT processes (incident and change management) in support. This enables the digital implementation of the IT processes described in the IT Compliance Framework for the efficient operation of an SAP system in the life sciences.
- Part 11-compliant electronic signatures
- Status of validation documents in dashboards
- Automation and digitalization of validation processes easily implemented
- SaaS solution = ready to use
WHY YOU SHOULD CHOOSE THE LIFE SCIENCES ALLIANCE?
- More than 25 years of expertise in the validation of computer systems in the pharmaceutical and medical technology industries
- Experienced team of CSV managers with in-depth knowledge of regulatory requirements
- Methodical, process-oriented and risk-based validation approach
- Large number of successfully completed validation projects with reference customers
- High audit reliability