Risk-based validation of computerized systems

Are you planning to validate your computerized system and want to achieve this in a short time and in compliance with regulations? Then we are your partner - seamlessly with perfectly functioning interfaces to the customer - both in the pharmaceutical and biotech industries as well as in other regulated areas such as medical devices.

Valicare supports you efficiently, innovatively, and sustainably in complying with the requirements for the validation of computerized systems (CSV) in Good Laboratory Practice (GLP), Good Clinical Practice (GCP), Good Manufacturing Practice (GMP), Good Distribution Practice (GDP), and for medical devices.

Often the details are the difficulty

The basic requirements for computerized systems differ only slightly in the specially regulated areas. This can lead to problems during inspections.

For example, some countries in the GLP area require that the source code of the software must be available in the test facility or can be provided at short notice. This requirement does not exist in the GMP-regulated environment.

In the GCP, GMP, and GDP area, the “Good Automated Manufacturing Practice 5” (GAMP® 5) 2nd Edition guidelines of the International Society for Pharmaceutical Engineering (ISPE®) have become established as a guideline for practical implementation.

The 2^nd edition clearly emphasizes the validation of medical devices and their business and production processes, including their computerized systems. This brings new challenges for manufacturers of medical devices, as the entire documentation is expanded to include validation plans, specifications, and validation reports along with the previous verification. We support you in this process of finding the gaps and filling these with the necessary documentation.

In the GLP area, Germany is guided by OECD Guideline No. 17 and Annex 3: Inspection of data processing (DV) systems of the Manual for GLP Inspections.

Depending on the complexity and criticality of the system, individual tests that are typically part of an overall validation can be assessed on a risk basis and omitted.

gmp services computervalidationdiagram-en — Essential regulatory requirements and recommendations

Our strengths are:

Proven concepts

We have ready-made and proven concepts and work instructions for CSV for both existing systems and new systems, as well as for replacing legacy systems.

Industry Standards

We apply industry standards to validate your systems comprehensively.

Many years of expertise

With our many years of expertise in validation, qualification, and verification, we are here to support you with your CSV.

Your benefits in collaborating with us lie in the fast and competent realization of your CSV project and the certainty of meeting the regulatory requirements for successfully passing inspections.

Hardware and software are included in the validation, as are the supporting business and production processes of the computerized systems. The entire product life cycle is considered in a risk-based manner and with critical thinking from planning to decommissioning, including 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 status, including the distribution of roles. In the area of CSV in particular, several groups of people are often involved, such as the system owner, the process owner, IT, quality assurance, users, and the validation team. In a first step, the roles must be defined and separated from the individual areas and the requirements and responsibilities for validation must be agreed.

Valicare's service includes external consulting and implementation services for the entire CSV process.

We offer our clients the following consulting services:

CSV consulting (project- or topic-related or on a daily basis)
CSV basic and advanced training
CSV project management
Code reviews

Planning of validation and creation or review of the validation master plan
Conducting risk assessments, risk analyses, and preparation /review of the traceability matrix
Preparation and review of Standard Operating Procedures (SOP) and Work Instructions (WI) for planning and operation as well as for the installation and decommissioning of hardware and software
Audits

At the documentation level, we offer our customers the creation of the following validation documents (design and planning documents):

Requirements Specification (RS)
Functional Specification (FS)
Configuration Specification (CS)
Software Design Specification (SDS)

Hardware Design Specification (HDS)
Software Module Design Specification (SMDS) for software of category 5 according to GAMP® 5
Definition and determination of the test strategy including test methods
Plans and protocols for:
- Alarm and function testing (AFT) for PLC and HMI systems
- Software Module Testing (SMT)
- Unit testing (UT)
- Configuration Testing
- Integration Testing
- Factory Acceptance Testing (FAT)
- Site Acceptance Testing (SAT)
- Installation Qualification (IQ)
- Operational Qualification (OQ) or functional testing
- Performance Qualification (PQ) resp. requirements or acceptance testing
- Definition and preparation of test cases

We provide our customers with exemplary support in the practical realization of validation:

Verification of the Software Module Design Specification by executing the Software Module Tests
Verification of the Software Design Specification, e.g. by conducting alarm and function tests for HMI systems, SCADA systems and vision systems
Performing verifications to ensure that systems are functioning as intended and meet regulatory expectations
Verifying the Functional and Hardware Design Specification by conducting alarm and functional tests for PLC systems, motion controllers and robot systems

Preparation of test reports
Handover documentation incl. administration and user manuals

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

Change management:
- Support in the management of changes to validated systems by assessing their impact, updating documentation, and performing the necessary revalidation incl. version and release management
- Configuration management
- Complaint management
- Problem and incident management
Operational processes and their periodic review:
- Monitoring of applications und IT infrastructures
- Backup and ecovery
- Archiving during ongoing operations
- Business continuity plan incl. regular tests
- Disaster recovery plan incl. regular tests
Support of migrations from a regulatory perspective and decommissioning of legacy systems
- Data and metadata to ensure data integrity (Annex 11 und Part 11: electronic records)
- Archiving of legacy data
- Disposal of data and hardware from the legacy system
Validation of:
- Management systems (ERP, document management, quality management, etc.)
- Process and control systems (MES, SCADA, BMS/EMS, process control and monitoring, etc.)
- Laboratory systems and equipment (LIMS, chromatography systems, specific laboratory equipment)
- Warehouse management systems, sterilization, and aggregation systems
- Medical device software (ISO EN 62304) and health software (ISO EN 82304)
- Qualification of IT infrastructures and cloud systems (IaaS, PaaS, SaaS)
- Monitoring of validation status (e.g. by periodic reviews)
- Electronic signatures (Annex 11 and Part 11)
- Audit trails
- Electronic Batch Record (eBR)
- Excel spreadsheets

We also offer training courses on all these topics relating to CSV. We offer these as classroom training courses and via our training portal, the CSV Academy:

The CSV Academy features a modular structure allowing you to choose the training courses that meet your specific needs. We will be happy to provide advice tailored to your current CSV situation or for trainings in general.
With the CSV Academy, training courses are available online anytime and anywhere.
Each online video training unit is followed by an online session with one of our experienced CSV consultants. You can ask him about the training content or your current CSV topics.
The following four modules are offered by the CSV Academy and the classroom training courses:
- Basic knowledge CSV
- The complete SDLC (System Development Life Cycle) according to GAMP® 5 in the 2^nd Edition
- Integration of suppliers
- Audits: preparation, execution, and documentation

Our services also include CSV, GxP, and GAMP® audits:

Preparation, execution, and postprocessing of audits
CAPA creation and follow-up
External audits such as supplier audits and service provider audits (such as data centers and cloud service providers)
Internal audits, e.g. of production areas, departments, computerized systems, and their business and production processes

Compliance audits according to the regulations 21 CFR Part 11 / Annex 11 EU GMP
Audits on data integrity process of computerized systems and hybrids
Mock audits
Creation, delivery, and evaluation of questionnaires

QMS audits
Audit of Quality Management Systems (QMS)
Audit of Information Security Management System (ISMS)

Downloads on Computerized System Validation

One Pager: CSV Overview

One Pager: CSV Audits

One Pager: CSV Trainings

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.