Expertise.
Computer System Validation
Use the best methods to validate and monitor your computerised systems.
Ready.
Be ready for FDA inspections and audits.
Sure.
Comply with the legal requirements.
Quickly.
Save valuable time for corrections.
Interested?
How we can support you in computer system validation.
- Identification of gaps to the status quo of the company
- Identification of pain points or key enablers to achieve 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
- Harmonisation of processes
- Creation of checklists for CSV assessments
- Process monitoring and life cycle management
- Improvement through digitalisation
- 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
- Categorisation and classification of validation complexity
- Continuous improvement and regular validation throughout the life cycle
- Project management
- Perform CSV for unit-software combinations or software
- Operational and advisory support
Need?
Why not book a QuickCheck?
Computer System Validation. 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 part of the team.
The Entourage is looking for life science professionals.
Case Study.
Implementation of documented proof of compliance with the basic requirements of GLP for a research laboratory. The laboratory had previously only been used for research, but also wanted to offer industry tests conducted under GLP. The entire documentation and laboratory organisation had to be developed and implemented from scratch.
Implementation.
The computerised systems were identified and evaluated. Harmonised documents and forms were produced. The devices were qualified (URS, TRS, DQ, IQ, OQ, PQ).
Outcome.
- Documented evidence has been established to achieve all GLP quality compliance requirements
- GLP status has been granted by the competent authorities
- Compliance with OECD No. 17
The goal was to remediate all equipment, software and processes for manufacturing various medical devices. Inadequate device qualification, software validation and process validation led to regulatory and quality concerns. Many processes were insufficiently risk assessed.
Implementation.
Design, process specifications and FMEAs are defined and created (URS, TRS, DS). Verification and validation plans have been established based on process endpoints and risk. Processes have been validated via risk-based statistical justifications.
Outcome.
- Full compliance with regulatory requirements
- Reduction of process times
- Improvement through definition of reliable process endpoints
- Compliance with OECD No. 17
Overview. Offer. Computer System Validation.
- Strategy for the validation of computer systems
- Best Practices for Cost Savings & Quality of the 21 CFR Part 11 Compliance Strategy
- Validation templates and system-specific packages
- Ongoing adaptation of the risk-based computer validation approach to current regulatory expectations
- Computer validation of global and local IT systems (e.g. ERP, LIMS, MES)
- Validation of laboratory and process control systems
- CSV Best Practices
- User requirements and process mapping
- Data migration verification strategy and implementation
- System tests (unit & integration tests, UAT)
- Planning, implementation and documentation of validation tests
- Best practices procedures to maintain the validated status
- Change management & periodic review
- 21 CFR Part 11 & EU GMP Annex 11 Assessments
- Risk prioritised & turnkey remediation projects
- 21 CFR Part 11 Inspection Readiness Projects
- Audits. (21 CFR part 11; Annex-11)
- Governance
- Data Integrity
