Qualification/CSV

‘Be compliant’

We satisfy all the requirements for the qualification of computerised systems, equipment and IT networks throughout the entire lifecycle in a professional and audit-compliant manner – based on your needs and the regulatory requirements at hand.

CSV new installation

CSV data collection infrastructure

To the project

Space and freezer mappings

GMP space and freezer mapping for chemical and pharma industry

To the project

Audit trail review

Implementing a system audit trail review process

To the project

Packaging qualification

Qualification of a pharma packaging line

To the project

PERFORMANCE

We support you with the qualification/computer system validation (CSV) of your systems – from the planning and project phase through the operational and decommissioning phases.

Flyer modular full service Flyer specialist planning

CONCEPTUAL DEVELOPMENT PHASE

We advise you on computer system validation/qualification and create the right strategy for you.

Assistance with or creation of the qualification/validation strategy
Compliance GAP assessment
Assistance/calculation of qualification costs

PLANNING AND PROJECT PHASE

We develop the necessary CSV/qualification documents for you, based on a clear concept, and handle the qualification process.

CSV – design/project management

Creation of (project and) qualification plans
Creation of specifications/URS
Creation of design documentation
Integration of external qualifications
Project management (schedules, cost controls, reporting, etc.)

CSV – GxP assessments

Creation of impact/compliance/data integrity assessments
Creation of risk analyses/FMEA
Creation of FDA 21 CFR Part 11/EU Annex 11 assessments
GAMP SW/HW categorisation

CSV – plan/document creation

Creation of qualification documents (DQ, FAT, IQ, SAT, OQ, PQ, Re-Q etc.)
Creation of work instructions (SOPs/WIs etc.)

CSV – implementation

On-site qualifications at our customers’ premises
Preparation of final qualification report (QSR)
Assistance with project management and commissioning
Assembly management

OPERATION PHASE

We define and create the necessary qualification documents for your systems and carry out the qualification process to suit the complexity and scope of your planned change.

Re-qualification of existing systems
Assistance with or implementation of periodic reviews
Assistance with or implementation of system audit trail reviews
Calibration and adjustment of physical measured variables
Temperature/humidity mapping

DECOMMISSIONING PHASE

The qualification cycle ends with the planned, orderly decommissioning of your plant. During this phase, we support you in developing and implementing the plan and ensure that your documentation is GMP-compliant.

Development of a decommissioning strategy for systems/plants
Creation and implementation of the decommissioning plan
Final calibration

EXPERTISE IN THE FIELD OF CSV/QUALIFICATION

We would be happy to support you with developing and executing your CSV/qualification, thanks to our wide-ranging process expertise.

Flyer Qualification/CSV

THE REGULATORY ENVIRONMENT: WHERE OUR EXPERTISE AND CORE COMPETENCE LIE

Manufacturing systems in pharma, chemical companies producing active ingredients, biotech, medtech
Packaging systems and end-to-end lines
Data acquisition systems for rooms and processes
Infrastructure systems and facilities
OT infrastructures (server platforms, networks, services)
Qualification (CSV) of GMP for third-party package units
Mapping of temperature control units and rooms

WORKING METHODOLOGY

Our comprehensive template documents have proven themselves over many years and are continuously being improved
We can quickly record your processes and then plan the design and implementation
We refine our approach on the basis of expert reviews (e.g. audits) and take current standards and guidelines into account