When QM works, it becomes a supporting structure. TentaConsult puts regulatory thinking into practice

TentaConsult stands for quality management that is not just created on paper but grows within the company and is practised on a daily basis. Each system is developed in such a way that it keeps pace with daily requirements. It does not stop at formal specifications, but creates space for real process clarity, clear responsibilities and comprehensible documentation.

"We don’t develop systems that are polished up for an inspection and then forgotten again. We create structures that are sustainable, even when requirements grow or the environment changes," says the TentaConsult team, describing its approach. Instead of adding individual solutions, we create comprehensive systems that integrate products, processes and people in equal measure.

Regulatory expertise with an eye for operational realities!

The basics of modern QM systems are well known. ISO 13485, GMP, GDP, GVP, ISO 9001, ISO 15378 or ISO 22716 form the foundation. TentaConsult does not simply transfer these standards but harmonises them with operational requirements and existing processes. The goal is a system that is not only compliant but also provides orientation in day-to-day operations and recognises sources of error at an early stage.

TentaConsult always shows particular strength when regulatory worlds overlap. This applies, for example, to combination products consisting of medicinal products and medical devices, to companies with several sites or different QM systems and to dynamically growing portfolios. It is not enough to fulfil individual requirements here. What is needed are well thought-out, compatible structures that integrate all levels, allow them to work efficiently and effectively and make the company audit-proof and future-proof.

QM consulting with depth, responsibility and vision!

TentaConsult supports companies throughout the entire product life cycle, from the initial idea to market surveillance. The spectrum ranges from the development and adaptation of complete QM systems, the maintenance of SOPs and the development of clear training programmes to gap analysis and the derivation of suitable improvements to existing systems.

TentaConsult offers a comprehensive range of QM services, including

• Development, expansion and integration of quality management systems

TentaConsult designs and implements individual QM structures that fit seamlessly into the existing organisation. The aim is to combine specifications from different standards in such a way that a consistent and auditable system is created.

• Development and maintenance of SOPs, forms, training concepts and procedural instructions
• Together with the companies, all quality-relevant documents are developed in a structured manner, organised in a practical way and maintained on an ongoing basis. This makes internal processes transparent, comprehensible and permanently stable for audits.
• Risk analyses in accordance with ISO 14971, HACCP and ICH Q9

The consultants carry out structured risk analyses, assess existing hazards and support the development of a consistent risk management file that is maintained throughout the entire product life cycle.

• Digital validation in accordance with GAMP 5, FDA 21 CFR Part 11, Annex 11 and ISO 80002

TentaConsult plans, documents and supports the introduction and validation of electronic QM systems. The changeover to digital processes always follows regulatory guidelines, with complete documentation and comprehensive training.

TentaConsult also assumes operational responsibility when companies need to bridge personnel gaps or have a short-term need for expertise. This is done, for example, by taking on the role of PRRC, QPPV, QP, VP, QMB/QS and similar positions or in project management. These interim roles are filled by experienced specialists who not only provide formal security, but also relieve and stabilise operations with their expertise and integration skills.

Method with attitude and precision

TentaConsult does not start with an Excel spreadsheet, but on the spot. The consultants hold personal discussions with those responsible, observe processes directly in the company, moderate workshops and gain a comprehensive insight. This results in solutions that are precisely tailored to the company.

Tools such as Turtle diagrams, RACI matrices, Ishikawa analyses and 5-Why methods are used in a targeted manner because they create transparency and clarify responsibilities. The aim is always to develop a system that maps operational procedures, relieves the burden on processes, makes goals achievable and develops the company further.

Reliable partner for regulated companies

TentaConsult advises companies throughout the German-speaking world, from start-ups to international corporations. Consultancy is always geared to the actual requirements. It is independent of the size or complexity of a company and is always geared towards strengthening operational resources, creating security and establishing sustainable structures.