Häufig gestellte Fragen
What does GxP validation mean for an ERP system?
GxP validation is the documented proof that a computerised system such as an ERP in regulated industries consistently and reproducibly meets the requirements specified for its intended use. The abbreviation “GxP” covers the “Good Practice” frameworks, such as Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), Good Clinical Practice (GCP) and Good Distribution Practice (GDP). In the ERP context, this primarily concerns quality-relevant functions such as batch management, release workflows, materials management and traceability. Purely administrative or accounting modules without GxP relevance, by contrast, usually fall outside the actual validation scope.
How does a GxP validation proceed (V-model, IQ/OQ/PQ)?
Validation typically follows a V-model and is guided by the ISPE industry guideline GAMP 5, whose second edition from 2022 emphasises a risk-based approach and “critical thinking” instead of rigid checklists. The usual stages are Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ), embedded between a validation plan with a risk analysis at the beginning and a validation report at the end. The higher the risk a function poses to product and patient, the more intensively it is tested, allowing the effort to be concentrated on the critical modules. Every step is recorded in countersigned test protocols so that suitability remains fully traceable.
Which regulations and standards apply to ERP validation?
Methodologically, the ISPE guideline GAMP 5 is the de facto industry standard, classifying software into risk categories and scaling the approach accordingly. For electronic records and signatures, the FDA regulation 21 CFR Part 11 applies in the USA and GMP Annex 11 in the EU, whose revised version is expected in 2026 following consultation on the 2025 draft. With its “Computer Software Assurance” guidance (finalised in 2025, updated in 2026), the FDA has also shifted its testing approach for production and quality system software in the medical device sector more strongly towards risk-based, leaner testing, without repealing the requirements of Part 11 itself. Which regulation specifically applies depends on the target market, industry and intended use of the system.
What is ALCOA+ and why is it important for ERP data integrity?
ALCOA+ is the central set of principles for data integrity in GxP environments; the original ALCOA acronym was coined in the 1990s in the FDA's sphere. The five core criteria are attributable, legible, contemporaneous, original and accurate, supplemented by complete, consistent, enduring and available. For an ERP, this specifically means that every quality-relevant data change must be logged with user and timestamp in an immutable audit trail, and that data must remain available and traceable across the entire product lifecycle. These are precisely the requirements that validation specifically verifies.
What does a GxP validation cost and how long does it take?
There are no reliable flat rates, as the costs depend heavily on system scope, complexity and the operator's own contribution; in practice, comprehensive ERP validations often fall within the mid five- to six-figure euro range. Pure licence fees typically account for only a smaller share, while implementation, customising, test execution, training and data migration cause the majority. Standard validation packages and qualification documents from the vendor can noticeably reduce the in-house effort. Since customising enlarges the validation scope, a restrictive customisation strategy has a direct cost-dampening effect.
Does an ERP have to be revalidated after every update?
Validation is not a one-off act, because every change to a validated system must be assessed through a documented change control procedure. A risk-based decision is made as to whether and to what extent re-validation of individual functions is required, rather than retesting the entire system every time. Larger interventions such as version upgrades, new functions or configuration changes generally trigger a requalification of the affected areas, while smaller patches often only require an impact analysis. A company-wide standardised validation framework helps keep this effort predictable and efficient.
Which ERP systems can be GxP-validated?
In principle, it is not the product but its specific use at the operator that can be validated, which is why responsibility for validation always remains with the company. Suitable systems are ERP solutions that provide an immutable audit trail, electronic signatures within the meaning of 21 CFR Part 11, a granular role concept and separate test and validation clients. Common in the DACH pharmaceutical and life sciences environment are established standard solutions with industry add-ons as well as specialised pharma suites that come with prepared qualification documents. These vendor templates reduce the in-house effort but do not replace the company-specific validation of the processes actually used.