Computer system validation

Computer system validation or CSV validates automated systems and provides producers of pharmaceutical products the security that their computer-operated processes and systems function in a consistent manner and in accordance with the valid regulations.

Are you interested in advice or support related to the validation of your automated processes and systems? The Pauwels Consulting CSV engineers have extensive experience in the field of CSV, GAMP 5© and relevant regulations, such as GxP, EU GMP and ISO.

We would be pleased to assist you with the implementation and optimisation of your automated system validation (CSV).

Computer system validation in practice

Automated systems within the pharmaceutical industry must comply with strict regulations, including USA FDA 21 CFR part 210, 211 and 11, GxP and EU GMP volume 4, annex 11. This is essential in order to prevent deviations during a later stage of the system development life cycle (SDLC) and to ensure a solid quality, security and operational reliability.

The objective of automated system validation, also known as computer system validation or CSV, is to ensure that an automated production system or process will deliver a specific result or product in a consistent manner, which complies with the predetermined specifications and quality requirements, and that this is fully documented.

In general, computerised system validation includes five phases:

  • validation master plan (VMP): documents the validation strategy;
  • design qualification (DQ): defines the system requirements and specifications;
  • installation qualification (IQ): verifies the installation requirements and design specifications;
  • operational qualification (OQ): verifies the functional specifications;
  • performance qualification (PQ): validates the user requirements.

Since CSV applies to hardware, software, peripheral devices, personnel and documentation, the validation also includes the implementation of all aforementioned elements (so not only the automated component).

Computer System Validation - Pauwels Consulting

Challenges within CSV

Pharmaceutical companies dedicate a high level of attention, effort and budget to validating automated systems. On the one hand, they act as such due to the upcoming projects including automated systems, such as the laboratory information management system (LIMS), electronic lab notebook (ELN), paperless processes, process automation, process analytical technology (PAT), etc.

On the other hand, computer system validation is confronted with more and ever stricter regulations on international level. For example, in recent years, the FDA has strongly emphasised data integrity. These new ‘limitations’ are often the result of the fact that systems are more and more connected.

This is why the main challenge for pharmaceutical companies at this time is to increase the efficiency of their validation process by implementing:

  • a risk-based approach;
  • a paperless validation process;
  • an efficient software/system development life cycle (SDLC) (such as Agile, Scrum, etc.).

Since digitalisation is increasingly becoming more important, computerised system validation will also play a more prominent part within the general validation of companies.

Computer system validation at Pauwels Consulting

Are you interested in advice or support related to the validation of your automated processes? Our CSV engineers and project managers have extensive experience in the field of validation processes. They would be pleased to assist you with:

  • CSV support with attention for valid regulations, GAMP 5© guidelines, the life cycle model (V-model) and new technologies;
  • advice on best practices in life science;
  • the formulation of SOPs for the various domains in accordance with the valid regulations (GMP, USP, EP, etc.);
  • the execution of GAP analyses;
  • the execution of risk analyses;
  • the formulation of a validation approach in accordance with the valid regulations (risk-based approach);
  • the formulation of validation documents (plans, protocols, reports, etc.);
  • the practical implementation of validation tests;
  • QA reviews;
  • data integrity;
  • the deployment of autonomous compliance teams (MSA).

Would you like to have more information?

Are you interested in more information regarding computer system validation possibilities for your organisation? Do not hesitate and contact us, without any obligations.

Our CSV engineers would be pleased to assist you with the preparation, implementation and optimisation of your automated system validation. As such, you will always provide the required quality in accordance with the valid regulations.