Expertise.

CSV Consulting.

Use the best methods for validating and monitoring computerised systems.

Ready.

Be ready for FDA inspections and audits.

Sure.

Comply with legal requirements.

Quickly.

Save valuable time for corrections.

Computer System Validation Consulting needed?

CSV Consulting: Efficient validation and monitoring.

Our CSV Consulting Service offers you the optimal solution for the validation and monitoring of computerized systems in the life science industry.

In the field of Computer System Validation (CSV), we combine technical expertise with a strategic approach to ensure that your systems not only comply with legal requirements, but also operate efficiently and error-free. Our specialist consultants have in-depth knowledge and many years of experience in validating complex IT systems, which enables us to develop tailor-made solutions for your specific needs.

Our team supports you in mastering the challenges of CSV. We start with a thorough analysis of your existing systems and processes, identify weaknesses and work with you to develop improvement measures. In doing so, we rely on proven methods and innovative approaches to sustainably increase the efficiency and security of your systems.

With our CSV Consulting Service, you are optimally prepared for audits and inspections. We ensure that all regulatory requirements are met and that your systems are audit-ready at all times. Through regular reviews and continuous improvements, we ensure that your systems always remain state-of-the-art and give you a long-term competitive advantage.

CSV Consulting: Your partner for validation and efficiency.

Experience how Entourage's CSV Consulting creates concrete benefits for your company.

Efficient validation.

Regulatory security.

Sustainable optimization.

How we can support you with Computer System Validation Consulting.

  • Identification of gaps to the status quo of the company
  • Identification of pain points or key enablers in order to achieve a significant improvement in the short and long term
  • Identification of regulatory requirements
  • Draw up the essential requirements in comparison with the customer's status quo landscape
  • High Level Review of processes
  • harmonization of procedures
  • Creation of checklists for CSV assessments
  • Process monitoring and life cycle management
  • Improvement through digitization
  • Trainings and workshops
  • Identification of the most important stakeholders
  • Visual performance management
  • Draft project roadmap
  • Detailed implementation planning
  • Creation and implementation of URS, TRS, IQ, OQ, PQ
  • Categorization and classification of validation complexity
  • Continuous improvement and regular validation throughout the life cycle
  • Project Management
  • Perform CSV for device-software combinations or software
  • Operational and advisory support

Computer System Validation Consulting needed?

Computer System Validation Consulting. Our offer

  • Checking existing validation SOP against current regulatory requirements
  • Checking for the presence and completeness of regulatory required documents
  • Review of existing user requirements and risk analyses
  • Expansion to audit all existing documents of existing systems (incl. traceability)
  • Preparation of reports with determination of necessary measures
  • Creation of user requirements and risk analyses for computer-based systems
  • Preparation of the DQ documents (design qualification)
  • Preparation of IQ, OQ and PQ plans (installation, functional and performance qualification)
  • Carrying out IQ, OQ and PQ according to the plans and preparing all reports
  • Preparation of all other necessary documents (e.g. validation plans, system description, traceability matrix, validation reports) within the scope of a validation project incl. project control
  • Audit, assessment of implemented measures for compliance
  • Carrying out data integrity assessments
  • Recording and documentation of quality-relevant processes > Data Integrity Flow Charts
  • Data Integrity Governance (SOP)
  • Data integrity audits against current laws and guidelines
  • Preparation of reports with determination of necessary measures
  • Preparation of Remediation Plans
  • Checking existing validation SOP against current regulatory requirements
  • Checking for the existence of documents required by regulation
  • Carrying out a Validation Compliance Check (review of all documents)
  • GAP analysis with risk analysis and definition of necessary measures
  • Audit, assessment of implemented measures for compliance
  • Preparation of reports with determination of necessary measures
  • Validation of complex IT systems (e.g. ERP systems)
  • Validation of Excel files in the laboratory
  • Target group-oriented training on the topics of CSV and data integrity

Become a part of the team.

Entourage is looking for life science professionals.

Case Study.

First and second level support
The aim was to integrate the processing of a backlog that had built up over several months into daily business operations. Due to a shortage of staff, the internal employees were no longer able to complete the work.

Implementation.

  • Management of the Windows server
  • First and second level support for office and laboratory staff
  • Relocation of a GMP-certified laboratory (including server room)
  • Planning of networks in laboratories/production areas including subnets/VLANs
  • Coordination of service providers of a laboratory and the associated controls of GMP guidelines
  • Employee training: MS Office, IT security and production programs

Outcome.

  • Achieving a cross-departmental and cross-location willingness to work together to solve problems by creating a common understanding of IT and GMP.
  • Support/planning in setting up and adapting the network infrastructure for laboratories and production.
  • Ensuring functional IT operations by checking/establishing backup procedures, updates and user accounts.
The aim of the project was to ensure data integrity in all aspects of the company's activities. This mainly involves the review and optimization of data management processes, the development and implementation of policies and procedures to ensure data integrity, and the training of employees. The project involved working closely with various departments, including production and quality control/assurance, to ensure that all activities comply with regulations and standards.

Implementation.

  • Creation of process data flow diagrams
  • Evaluation of processes within the departments
  • Gap assessments of computerized systems and electronic devices
  • Implementation of concepts for checking test protocols
  • Implementation of access and user management
  • Risk analyses and revisions of documents in the life cycle
  • Definition and tracking of remedial measures

Outcome.

  • Refinement of process standards and the establishment of a robust data integrity approach increase compliance requirements.
  • Ensuring GMP-compliant operations through gap assessments of computerized systems and electronic devices.
  • Cost-effective and risk-based restructuring approach without re-validation.
FDA audit preparation. Assessment of the current state of all systems used at multiple sites in terms of data integrity and existing validation documentation in preparation for the FDA review. As a result of the above activities, a detailed report was produced that considered the deficiencies and what needed to be completed. The next step was to develop a remediation plan to make the systems compliant with FDA 21 CFR Part 11.

Implementation.

  • Assessment of data integrity
  • Evaluation of the existing validation documentation
  • Evaluation report
  • Restructuring plan

Outcome.

  • Complete assessment of the current status of the company's software and validation documentation as part of the audit preparation.
  • The project was successfully completed under high time pressure. All deficiencies in the data integrity of the systems were rectified.
  • The FDA test was passed on the basis of the work carried out.
CSV remediation in accordance with FDA CFR Part 11 and EU Annex 11. Following the merger of two companies, it was decided to embark on a major CSV remediation project. It included software/safety/setting updates, followed by full validation to ensure the sites were compliant with FDA CFR Part 11 and EU Annex 11.

Implementation.

  • CSV restructuring plan
  • Software/security/settings updates (120 systems)
  • Complete validation (validation plan, user functional/requirement specifications, risk analysis, configuration and design specifications, test plans, test scripts, test execution, validation report, traceability matrix)
  • Project management (management of a 12-person team on site at the customer's premises)
  • Establishment of a new role concept with key users, process and business owners

Outcome.

  • Validation of 120 systems in accordance with the remediation plan.
  • Each system fully validated (including test plans and tests).
  • 12-strong team was managed as project managers on site at the customer's premises.
Creation and implementation of an SAP S4/HANA basic data process. Creation of a new concept that describes how the basic data for the new system is created and processed: SAP S4/HANA. Collection of the necessary data from the respective departments and their business processes (BI). Creation and training of a complete concept to be followed by the user, including training.

Implementation.

  • Collection of data and BI
  • Creation of the actual process
  • Training of key users and end users

Outcome.

  • The new concept describes how the basic data for the new system to be implemented will be created and processed: SAP S4/HANA.
  • Full transparency of all ongoing projects and resource allocation for effective management.
  • The project was successfully implemented under high time pressure.
Implementation, validation and migration. Switching from one Learning Management System (LMS) to a new one: Veeva Quality Docs and Vault Systems. The challenge was to implement and validate the entire system according to standard GMP guidelines and to migrate all training data, documents and user data to the new system. In addition, old documents were to be migrated from servers and Microsoft SharePoint to the new system.

Implementation.

  • Validation of the system
  • Implementation of the system in standard operating procedures (SOP) and business processes (BP)
  • Collection of documents and data to be migrated
  • Actual migration of the data
  • Review of validation and migration (UAT/PQ and migration tests)
  • New role concept and training for administrators, key users and end users

Outcome.

  • Customized and documented tested workflows ensure user security and system stability.
  • Risk-based migration strategies with verification of the transferred data guarantee the validity of the data.
  • Cost-effective and risk-based validation approach and fulfillment of compliance requirements.
Conception, documentation and training. The challenge: Support by creating a concept for the implementation of an SAP ERP PP module. This module was implemented as a production logbook. Training of key users and end users for the use of this new module.

Implementation.

  • Creating a concept: How to use the logbook
  • Updating the standard operating procedure (SOP) and business processes (BP)
  • Training of key users and end users

Outcome.

  • Completed concept for implementing the PP module.
  • Introduction of an SAP-based production logbook.
  • Successfully conducted and documented training for key users and end users.

Overview. Offer. CSV Consulting.