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Regulation Compliance

SONNE delivers structured and reliable validation.

We adhere to our customer’s quality and compliance procedures, or if the customer prefers, we offer to use our own platform. The keys to our approach, when delivering process and machine risk assessment, qualification, and validation include ISO Standards, Good Manufacturing Practice, and GAMP 5.
SONNE ensures consistency in quality according to process and machine requirements, including:

SpecificationsRisk assessmentDesign reviewSoftware testingFAT and SATIQ-OQ-PQ

Require validation services, or have questions?

0608_B

Bjarne Ravndal Andreasen
Head of Quality & Compliance
ba@sonne.com
+45 36 56 76 34

0608_B

Bjarne Ravndal Andreasen
Head of Quality & Compliance
ba@sonne.com
+45 36 56 76 34

ISO Standards

With Lead Auditor expertise, both workflow and quality will meet ISO standards relevant to the given industry.

Good Manufacturing Practice

Our quality platform complies with Good Manufacturing Practice.

GAMP 5

Quality control is by design built into all stages of the manufacturing process.

ISO Standards

With Lead Auditor expertise, both workflow and quality will meet ISO standards relevant to the given industry.

Good Manufacturing Practice

Our quality platform complies with Good Manufacturing Practice.

GAMP 5

Quality control is by design built into all stages of the manufacturing process.

We are dedicated to ensuring our customers comply with relevant standard and regulations

Our consultants stay up-to-date with knowledge and procedures via training and courses. We ensure that machinery and processes comply with Good Manufacturing Practice (cGMP) and Good Automated Manufacturing Practice (GAMP).

Within Pharma and Medico our consultants ensure compliance with relevant standards and regulations required by EMA and FDA.

Our approach to compliance delivers solid technical documentation, required for CE-marking.

Case: Medico/Pharma packing machine

Packing Machine Design and Hand-over

SONNE proudly assisted its customer, a sub-supplier to one of the largest international pharmaceutical manufacturers located in Denmark, in the design and hand-over of a packing machine.

The pharmaceutical manufacturer was launching a new product. A new packing machine had to be developed, ready for product launch, and therefore keeping the time schedule was essential. Due to resource constraints, our customer asked SONNE to assist with the development and design of a new case packer module for the packaging machine – effectively scaling up the sub-supplier’s project team to reduce the time schedule.

SONNE had 4 employees tasked with the assignment, including work on 3D design, 2D documentation and design specification documentation, as well as one Team Lead supporting the project management. The 3D design and documentation of the case packer module only took 4 months.

Compliance Specialist Assistance

The entire packaging machine consists of 28 modules and is designed to meet good manufacturing practices (GMP). More than 600 installation and functionality requirements were included in the User Requirement Specification and had to be tested during the factory and site acceptance test.

The customer had one of SONNE’s Quality & Compliance Specialists assist with a variety of tasks, including:

  • Building a customer keyword database with a pretest plan and traceability matrix.
  • Design specification review in collaboration with the end-customer.
  • Writing test plans and performing review with the end-customer.
  • Performing FAT, including deviation closure and report.
  • Performing SAT, including deviation closure and report

Packing Machine Design and Hand-over

SONNE proudly assisted its customer, a sub-supplier to one of the largest international pharmaceutical manufacturers located in Denmark, in the design and hand-over of a packing machine.

The pharmaceutical manufacturer was launching a new product. A new packing machine had to be developed, ready for product launch, and therefore keeping the time schedule was essential. Due to resource constraints, our customer asked SONNE to assist with the development and design of a new case packer module for the packaging machine – effectively scaling up the sub-supplier’s project team to reduce the time schedule.

SONNE had 4 employees tasked with the assignment, including work on 3D design, 2D documentation and design specification documentation, as well as one Team Lead supporting the project management. The 3D design and documentation of the case packer module only took 4 months.

Compliance Specialist Assistance

The entire packaging machine consists of 28 modules and is designed to meet good manufacturing practices (GMP). More than 600 installation and functionality requirements were included in the User Requirement Specification and had to be tested during the factory and site acceptance test.

The customer had one of SONNE’s Quality & Compliance Specialists assist with a variety of tasks, including:

  • Building a customer keyword database with a pretest plan and traceability matrix.
  • Design specification review in collaboration with the end-customer.
  • Writing test plans and performing review with the end-customer.
  • Performing FAT, including deviation closure and report.
  • Performing SAT, including deviation closure and report

The tasks were performed on all 28 sections of the machine in collaboration with the sub-supplier and end-customer.

Q&C_ISO
Packing machine automatiseret til pharma og medico.
Packing Machine Automatiseret Til Pharma Og Medico.
Employee Profiles

CARSTEN

Valideringsspecialist med GAMP5 kvalifikationer.

VALIDATION SPECIALIST

Carsten is a Validation Specialist with GAMP5 qualifications, a degree in Electronics Engineering, and strong competencies in qualification and documentation.

Via his work at Bang & Olufsen, Carsten has gained more than 35 years of experience in the Electronics Industry and has subsequently transferred his extensive knowledge on technical production and specifications, including IQ/OQ/PQ, to the Pharma/Medico Industry.

Carsten approaches his work within qualification and validation in a structured and systematic way to ensure the production of high-quality products. During the design process, Carsten eliminates any potential risk factors by examining the requirement specification and implementing risk assessment. Moreover, he utilises his GMP knowledge and excellent documentation skills when validating complex machines for the Pharma/Medico industry.

“I operate the tension field between the machine manufacturer and the customer, so by means of facts, evidence, and diplomatic mediation, I ensure the finalised machine fulfils the agreed specifications and safety requirements”

LEIF

Leif Rahr

QUALIFICATION SPECIALIST

Leif is a Qualifications Specialist, holds a degree in Mechanical Engineering and specialised in CE marking, quality assurance, and management.

Having worked for more than 20 years in a variety of industries including food, wind, consulting and construction, Leif has extensive experience in risk analysis, quality assurance, CE marking and management from companies such as FRECON and Arla.

Leif makes use of his deep understanding of the relationships between sales, production, and quality management when working with quality and compliance. Through structure and planning, he firmly commits and implements CE marking of complex projects, always ensuring to represent the manufacturer while considering customer requirements.

“I am well-versed in my role and emphasise on good communication, which for instance means holding informational meetings regarding project possibilities that result in collectively increased understanding concerning complex risk assessment or CE marking tasks – I like to motivate and inspire project members to make projects successful.”

JAN

Jan_Thunbo_Web

SENIOR PROJECT MANAGER

Jan is a Senior Project Manager, has an M.Sc. Computer Science and extensive experience from the Consumer Electronics Industry.

After 20+ years working in consumer electronics, Jan has spent the past 2 years as a Project Manager in the Wind Industry, as a consultant for Siemens Gamesa. At Bang & Olufsen A/S, Jan gained more than 15 years’ experience with Project and Personnel Management – having started his career at the company as a Software Developer.

With his past work in electronics and software, Jan has a solid understanding of a project’s technical aspects. In the Wind Industry, he has run a portfolio of projects delivering service tools for a specific turbine platform. He manages projects focusing on values such as trust, transparency and empowerment of the team. His approach is structured and holistic, thriving in the interaction between team and stakeholders, Jan works towards the common goal.

“My experience, from many years of managing development projects in different industries, helps me recognise and address challenges in time to minimise their impact and safeguard the delivery to the customer”

EVA

eva_web_600x600_ny

MECHANICAL DESIGN ENGINEER

Eva is a Mechanical Design Engineer with a B.Eng. in Integrated Design and is a strong, adaptable problem-solver.

Eva has been quick to gain valuable experience from several different industries and companies of various sizes, including employment at LEGO, One Wood Furniture, and LM Wind Power. This allowed her to perform in roles as both a specialist and an all-rounder.

Thanks to her degree, Eva is trained in easily adapting to the different issues that may arise during product development projects. Her approach is built up around an iterative stage-gate model, which takes all relevant aspects of a project into consideration from idea generation to implementation.

“I’m a perfectionist professionally, however, I remain aware of project and time limitations to deliver the optimal piece of work. I thrive on surrounding myself with smiles. It is my goal to make people around me feel comfortable when working towards a common goal, which improves collaboration and adds value to the customer.”

MORTEN

Morten_Toftlund

ELECTRICAL MECHANIC

Morten is a qualified Electrical Mechanic with extensive experience within production automation and PLC solutions.

Morten has more than 20 years of experience working with automation and machine assembly, and he has worked specifically in the Pharma/Medico Industry for over 13 years, fulfilling essential tasks at Coloplast A/S in software maintenance, SQL database maintenance, and optimisation.

In his job as Electrical Technician Consultant, teamwork and dialogue are keywords in Morten’s work. As customers hand in a variety of requested features, he takes responsibility of understanding their exact wishes and delivering the best possible solution. He uses his extensive experience with Rockwell Factory Talk View and Rockwell RSLogix 5000 to create and optimise PLC and HMI solutions.

“From the very beginning of a project, my focus is on dialogue. Understanding what the customer wants and their fundamental approach is essential when creating or optimising technical software solutions – not only does this approach achieve better results for the customer, but it also eases the entire project process”

MORTEN VIE

Maskiningeniør fra engineering med ekspertise i 3D-design og produktion.

MECHANICAL ENGINEER

Morten is a Mechanical Engineer with expertise in mechanical design and design of 3D modelling for production.

With more than 20 years of experience in design of mechanical solutions, and having begun his career as a Mould Maker and Designer, Morten has held various positions at both CB Værktøj and Oticon, including Project Manager, had responsibilities as Team Lead, and gained experience with engineering services.

Morten’s wide-ranging experience makes him highly qualified in terms of conceptual mechanical design as well as the creation of the detailed 3D-models for production. When designing, Morten heavily considers the manufacturing and assembly procedure in order to ensure a smooth production process. He often acts as Team Lead, as he makes sure the functionality of the design maintains emphasis.

“I focus on finding solutions – It is deeply satisfying to find mechanical solutions to challenges, and I am not averse to out-of-the-box thinking to make a project successful”

THOMAS

Thomas_Dahl

ELECTRICAL DESIGN ENGINEER

Thomas is an Electrical Design Engineer and Consultant with a degree in Industrial Electrical Engineering and comprehensive knowledge of machine assembly.

Thomas has more than 20 years of experience in electrical engineering and machine assembly for the pharma/medico industry. He has solved a variety of tasks, including industrial installations and machine assembly tests, during previous occupations at Coloplast A/S and Elcon Thisted A/S.

Due to a high professional pride, Thomas finds utmost satisfaction in keeping project deadlines. He ensures that documentation complies to all applicable regulations and standards, and he attentively approaches risk assessment and safety checks to ensure they are prioritised during the construction process.

“For me, a central criterion for success is close dialogue with the customer from the very beginning of a project all the way until delivery.”

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