Risk-based validation of computer systems

Are you planning to validate your computer quickly and in compliance with regulatory requirements? We are your partner in pharma, biotech, and other regulated environments.

Valicare supports you in implementing the requirements for computer system validation (CSV) in GLP (Good Laboratory Practice), GCP (Good Clinical Practice),GMP (Good Manufacturing Practice), GDP (Good Distribution Practice), and for medical devices.

The devil is in the details

Basic requirements related to computerized systems differ in detail, which can cause inspection issues. For example, source codes must be available in a GLP-regulated test facility in various countries or must be obtained timely. In the GMP-regulated environment, however, this requirement does not exist.

The "Good Automated Manufacturing Practice 5" (GAMP 5) of the International Society for Pharmaceutical Engineering (ISPE) has prevailed as a guideline for practical implementation in the GCP, GMP and GDP area.

Germany further follows OECD Guideline No. 17 and Annex 3 of the Manual for the Performance of GLP inspections.

Depending on the complexity and criticality of the system, individual checks, which are typically part of an entire validation, can be assessed on a risk-base and committed.

gmp services computervalidationdiagram-en — Essential regulatory requirements and recommendations

Our strengths are:

Proven concepts

We have proven concepts and work instructions for CSV ready for both existing and newly purchased systems.

Industry standards

We apply industry standards to validate the systems comprehensively.

Expertise

We use our expertise in validation, qualification, and verification to support you in CSV.

Your benefit is a fast and competent implementation of your computer system validation project, the assurance of meeting regulatory requirements, and therefore a good basis to pass upcoming inspections successfully.

Hardware and software are included. The entire product life cycle is considered as a risk-based approach, from planning to decommissioning covering operating environments, networks, and databases, if necessary.

Consulting projects often start with an inventory

At the beginning of the consultation, our experts review the current state, including the distribution of roles. Several groups of people are often involved in CSV, such as IT, quality assurance, users, and the validation team. In a first step, the roles must be defined for the individual areas, and the requirements and responsibilities for validation must be coordinated.

Valicare provides external consultancy and execution services regarding the entire CSV process.

Our consulting services include:

CSV consulting (project or topic-related or daily)
CSV basic & advanced educational training
CSV project management
Code reviews

Planning of validation and review or preparation of the validation master plan
Execution of risk assessment, risk analyses, and generation/review of the traceability matrix
Preparation and review of standard operating procedures for the design, operation, installation, and disposal of hardware and software

We offer the preparation of validation documents (design and planning):

User requirements specification (URS)
Functional specification (FS)
Software design specification (SDS)
Hardware design specification (HDS)

Software module design specification (SMDS) for software category 5 acc. to GAMP5
Plans and protocols for:
- Alarm and function testing (AFT) plan for PLC & HMI systems
- Software module testing (SMT) and/or unit testing (UT)
- Configuration testing
- Requirements testing
- Integration testing
- Definition and preparation of test cases

We support you in “hands on” validation execution, for example with:

Verification of software module design specifications by executing software module testing
Verification of software design specifications by executing alarm and function testing for HMI, SCADA, and vision systems
Testing and verification to ensure systems operate as intended and meet regulatory expectations
Verification of functional specification and hardware design specifications by executing alarm and function testing for PLC systems, motion controllers and robot systems

Preparation of test protocols

We are also your partner for changes to already validated systems or the validation of special systems or tools:

Change control:
- Assistance in managing changes to validated systems by evaluating their impact, updating documentation, and executing necessary re-validation

Validation of:
- Excel spreadsheets
- Computer-aided laboratory systems
- Laboratory information management systems (LIMS)
- Manufacturing execution systems (MES)
- Electronic signatures
- Audit trails
- Electronic batch record/report

We offer the desired validation, from pure consulting or processing of individual subareas to complete implementation including documentation.

Free first consultation now!

Dr. Ellen Sons-Brinkmann
Phone: +49 69 153 293 709

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Our Company

Valicare is an ISO 9001-certified service company and operates in the area of qualification and validation of technical equipment and processes.