Our "qualification management model" transforms regulatory compliance requirements for complex operations into structured processes. 

As part of the qualification service, we fully map the life cycle of systems, equipment and plants according to EU-GMP Annex 15 and the ECA Guide. The expertise ranges from laboratory aids of USP <1058> groups A/B (pH meters, scales) to software-based systems of category C (GC/HPLC, CDS software, particle counters) to complex production lines and sterile technology restricted-access barrier systems (RABS, isolators, freeze drying, autoclaves, single-use systems (SUS), pure steam, water for injection (WFI)). One core competence is the qualification of individual constructions, prototypes, and special constructions (e.g., for advanced therapy medicinal products (ATMP)). 

As part of the validation service, we focus on the stability of your production processes (process validation, continuous process validation), cleaning procedures (cleaning validation via PDE, bracketing, dirty hold time (DHT) or clean hold time (CHT), laboratory methods (ICH Q2(R2)) and IT applications (CSV according to EU-GMP Annex 11, GAMP 5, FDA 21 CFR Part 11). Together, we design plans that strictly meet pharmacopoeias (USP, Ph. Eur., JP) and standards such as ISO 14644, pre-use post-sterilization integrity testing (PUPSIT), and gowning (Class B) – for maximum audit compliance. 

We undertake the preparation and maintenance of all regulatory GxP documents (including validation master plan (VMP), contamination control strategy (CCS), qualification plans and reports, FMEA risk analyses and periodic reviews) in the operational phase. 

Our team manages all actions with foresight to ensure that your operations remain compliant with the current state of technology and guidelines such as the amended EU-GMP Annex 1. 

A systematic change control management and deviation management (including Out-of-Specification (OOS), Out-of-Expectation (OOE), Out-of-Trend (OOT)-surveys and CAPA processes) complete our concept for seamless audit trail integrity. 

To strengthen efficiency, we process document-based GMP services via remote access on request. 

We integrate directly into your QM structure and fill the role of external qualification manager. Transfer regulatory responsibility to experts and turn complex demands into highly efficient, resource-saving routines. 

For a successful project start, we need a valid data basis to assess your current regulatory compliance status. Therefore, our strategic launch begins with a detailed inventory of all equipment and laboratory systems via an inventory audit or gap analysis. 

For efficient integration of our services, we systematically analyze your quality guidelines and SOPs, your qualification documents, cleaning validations as well as system audits in search of regulatory discrepancies. For a risk-free, rule-compliant project start, this step realizes the precise alignment with current regulatory expectations and technological standards (including the amended requirements of EU-GMP Annex 1). As part of our communication management, all stakeholders are already involved from the initiation phase of the project and kept up to date via the agreed communication channels and defined intervals. 

The joint determination of system criticality, risk-oriented according to USP <1058> and GAMP 5, as well as critical process parameters (CPPs) and critical quality attributes (CQAs) ensures that project resources are placed in a focused manner with the highest relevance for product quality and process stability. 

We would be happy to review and supplement the responsibility matrix (responsible/accountable/consulted/Informed, RACI model) of your organization. Together with you we enable a smooth workflow and ensure the necessary traceability in the value-adding qualification and life cycle management process by systematically evaluating logbooks, process data and maintenance reports. 

• We tailor our methodology precisely to your in-house standard processes and establish a qualified master schedule for all upcoming validation and qualification activities (cyclic intervals, event-driven reconciliation or continuous process verification). This is risk-based according to USP <1058> and GAMP 5 as well as under the time- and cost-saving inclusion of existing FAT and SAT results (factory acceptance test/site acceptance test) of the plant manufacturer
• In addition, we design the necessary SOPs, FMEA risk analyses as well as higher-level framework documents (validation master plan (VMP)) if required and carry out a differentiated system classification, whereby we use your resources in a targeted manner and thus economically:
• Category A plants: apparatus without direct influence on product integrity or test results (resource-saving implementation of a pure system classification)
• Category B facilities: Targeted instruments with a manageable range of functions and mandatory calibration requirements (implementation of DQ and metrological calibration)
• Category C plants /structured systems: Software-supported, complex standard components (standardized, efficient execution of DQ, IQ and OQ)
• Tailor-made large plants, sterile technologies and special machines: Customer-specific complete systems and special constructions (comprehensive assurance through the full qualification cycle of DQ, IQ, OQ and PQ including sterility assurance level certificates, comparison with the contamination control strategy as well as PUPSIT tests) 

To optimize the overall effort, we use targeted matrix and bracketing concepts for related instruments, system and substance classes (e.g. in cleaning validation) and reduce your cost and time. 

We revise or design the risk assessments in direct dialogue with your experts. For full transparency in every project phase, we set up the information channels in parallel and structure reporting for the parent steering committee. 

We implement all the qualifications, requalifications and validation processes (such as SWAB/rinse sampling or media-fills) in advance to keep your GxP documents permanently up to the current state of the art. Through the analysis of process metrics (SPC), we enable the transition from rigid intervals to needs-based condition monitoring (condition monitoring), which allows for early detection of creeping efficiency losses. 

If your site lacks the necessary testing technology, we draw on our own pool of calibrated measuring devices. 

Life cycle adjustment for modifications: 

We integrate all efforts through new system additions, equipment modifications (change control) or process extensions smoothly as tailor-made additions into the ongoing process. Through the continuous reconciliation of assets and capacities, we ensure that deactivations and new installations are permanently billed, keeping your project structures maximally agile and economically efficient. 

Economic optimization & scalability in project progress: 

Our qualification strategy is based on the real number of systems and the degree of complexity of your project in a flexible and dynamic way. For your company, this results in the best possible budget efficiency. Both in separate functional units and in multi-disciplinary large-scale locations or highly complex production lines, you only pay for the capacities that you really need. 

Flanking GMP consulting services, the development of a site-wide contamination control strategy (CCS), gowning qualifications as well as the accompaniment of official inspections (including back-office organization and audit preparation) are integrated into the overall project in an agile and modular manner. In this way, we manage new challenges with high flexibility, achieve the best possible audit security and prevent the administrative burden on your project from increasing.