Pharma & Healthcare Quality Management

The right validation strategy for GxP compliant IT system environments. With our IT Validator System, we simplify and accelerate the validation process with the highest compliance conformity - as a service :-)
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Computer system validation is a standard task in more and more industries to comply with and maintain applicable regulations and to protect patients. Yet the process is often still very time-consuming and unnecessarily slows down the specialist departments and the business. The effort to realise this in an error-free, consistent and fully traceable manner is extremely time-, resource- and thus cost-intensive.

Validation packages
We validate your IT systems according to all regulatory requirements - simply and compliantly.
Risk-based also cloud validation
Through our special validation strategy Compliance also for Cloud and SaaS systems
Quality process
Follow-up requires an integrated routine in the daily work processes of the departments.

Over 80 change control procedures make us a reliable and competent IT quality management partner. Some examples of our special GxP-compliant validation packages.

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Change Control

is a process within quality management systems and information technology systems to ensure that changes to a product, process or system are introduced in a controlled, monitored, and coordinated manner.

Catalog of Measures

Defines which measures are used to assess whether an IT change has been successfully executed and implemented.

Design Qualification

Is defined as a verification process on the design of a product/system to meet particular requirements relating to the quality of the product/system (e.g. relating to the pharmaceuticals and manufacturing practices).


Refers collectively to all guidelines for "good working practice", which are of particular importance in medicine, pharmacy and pharmaceutical chemistry. The "G" stands for "Good(e)" and the "P" for "Practice", the "x" in the middle is replaced by the respective abbreviation for the specific area of application.


A regulation set forth in EU law on data protection and privacy in the European Union (EU) and the European Economic Area (EEA) that also addresses the transfer of personal data outside the EU and EEA, with the primary goal of giving individuals control over their personal data.


A federal agency of the Department of Health and Human Services in the United States, responsible for protecting and promoting public health through control and supervision of food, pharmaceutical drugs, vaccines and various different products.


International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH); The ICH pursues the goal of standardizing the criteria for admission of a drug in e.g.Europe, the United States, Japan.


Installation Qualification (IQ) verifies that the device or system to be qualified (as well as its subsystems and any ancillary systems) has been installed and configured according to the vendor's specifications or the installation checklist.

IT Change Request

Is a document containing a call for an adjustment of a system, declaring what needs to be accomplished but leaving out how the change should be carried out.


GAMP refers to Good Automated Manufacturing Practice. A system for producing quality equipment using the concept of prospective validation following a life cycle model. Specifically designed to aid suppliers and users in the pharmaceutical industry.


Determines that equipment and software performance is consistent with the user requirement specification within the vendor-specified operating ranges.


Establishing confidence through appropriate testing that the finished product or process procuded by a specified process meets all release requirements for functionality and safety and that procedures are effective and reproducible under real conditions.

RA -
Risk Analysis

The process of identifying and analysing any potential issues that could negatively impact key business initiatives or projects.

Requirement Specification

A collection of the set of all requirements that are to be imposed on the design and verfication of a product or project.

SOP - Standard Operating Procedure

Standard Operating Procedure

21 CFR
Part 11

Part of an FDA regulation on electronic records and electronic signatures, in detail it defines the criteria under which electronic records and electronic signatures are considered trustworthy, reliable and equivalent to paper records.

TM or TMX - Traceability Matrix

Traceability Matrix - the key document for qualification. The traceability matrix clearly documents which user requirements (URS) are tested against which function of the system (TS-FS/DS/CS) in which qualification test or tests (DQ, IQ, OQ, PQ).

VR - Validation

is a document that summarizes all validation results and procedures done in order to ensure that certain products and services consistently maintain satisfactory quality.


Validation Master Plan

Validation Pool

Systems only used for validation purposes depicting the production structure but without contact to the real infrastructure or business processes.


User Requirement Specification

Further information?

Our experts will be happy to answer your questions in a free initial consultation.
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Our clients and industries

From Industry to Pharma to Financial