Azimuth - Quality GmbH, Basel

Consultancy for quality concepts in the life-sciences industry

Consultancy on technical quality concepts from projects and site releases up to routine production; lean and compliant strategies, concepts and implementation support.

Commissioning, qualification and validation strategies

Design and implementation of C&Q master plans, VMPs, policies and SOPs, as well as ongoing programmes, including strategy selection and GMP-compliant documentation.

Risk assessments and gap assessments

Risk assessments for qualification, process, contamination, containment and maintenance, as well as gap assessments on compliance and processes.

QMS implementation and improvement

Implementation and improvement of quality management systems for start-ups or growing companies, aligned to structure, process and operating phase.

Engineering quality, maintenance and calibration strategies

Strategies for engineering quality, maintenance and calibration, including concept design, programme set-up, spare-part considerations and QA roles.

Process Performance Qualification, process validation and ongoing process verification

PPQ, process validation and ongoing process verification for biotechnological, aseptic, sterile and other manufacturing environments.

Contamination control strategies

Contamination and containment concepts for implementing Annex 1 requirements, supplemented by additional studies, monitoring and physical measures.

Environmental monitoring and disinfectant efficiency studies

Environmental monitoring with limit definition, trending and room qualification, as well as studies on the effectiveness of disinfectants.

Sterility expertise

Technical support for sterilisation and depyrogenation within qualification, validation and GMP environments.

Cleaning validation and hold-time studies

Cleaning validation, CIP cycle development, selection of cleaning and disinfecting agents, as well as hold-time studies and sampling concepts.

Computer system validation

CSV for equipment and applications, data integrity, 21 CFR Part 11 and Annex 11, as well as validation of cloud solutions.

Audits and audit preparation

Audit preparation, participation in audits, mock inspections, as well as support for findings and CAPAs by subject matter experts.

Azimuth - Quality GmbH

About the company

Products & services

Looking for direct email addresses and phone numbers?

Azimuth - Quality GmbH

About the company

Products & services

Looking for direct email addresses and phone numbers?

Azimuth - Quality GmbH in comparison

Industry comparisons are coming soon

No knowledge articles yet

Similar companies