QUALITY ASSURANCE (QA)

Solutions in compliance 

The approval of the authorities is a “license to operate” within the life science industry. Thereby it is important to meet the requirements in the applicable legislation. In theory it should be an easy task to transform rules into solutions in everyday operations. In practice, it will often give rise to questions when it comes to interpretation and implementation:

Which authority requirements should the company meet? What does it take? When is it adequate? Which solutions will fit the company’s processes and ensure compliance? How fast can it be done? How do we maintain level of compliance?

AlfaNordic assist life science companies to achieve and stay in compliance. Our experienced consultants know the legislation and create effective solutions giving value for the company and comply with existing requirements of the authorities.
Find solutions in compliance, with the help of AlfaNordic.

SOLUTIONS WITH VALUE

We create meaningful solutions in compliance.

The goal is to ensure the company will meet requirements to achieve the approval of the authorities. Based on the single company and by streamlining of existing business processes we ensure that they meet the requirements of compliance.

The requirements of the authorities have to be abided by. We have experience and knowledge about the most common pitfalls and will set the needed level of compliance in correlation to the company’s size and the risk profile of the products.

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PROFESSIONAL DIALOGUES

Our team of specialists have a wide range of experience with quality: We work with several different types of products and companies, within R&D, RA, QA and production. This gives us the possibility to look at the task from multiple perspectives and ensure a common understanding of the solutions.

Professional dialogues are our most important tool, as compliance often is a question about pros and cons: What does it take, if we choose to do A instead of B? What consequences does it have?

The quality people have a reputation of saying no. We will do the same if we assess that something is professionally indefensible. Based on rules and guidelines, we argue to make it clear why a no is a no-go. By doing things this way, we ensure that everyone understands the background of how things are to be done in a certain way.

Our goal is to make sure that the entire organization will achieve and stay in compliance.

EFFCTIVE SOLUTIONS OF OPERATIONAL TASKS

It can be difficult to get everything done on a busy working day. We offer to solve practical tasks to ease the pressure of the regular team.

The tasks are as different as the companies’ needs: Among other things, we reduce stacks of deviations, support the production and solve other practical day-to-day tasks.

Regardless of the task, we will show up with professional and experienced operational consultants. We ensure that they will solve the task efficiently and deliver results in due time.

By doing things this way, we help our customers to get operational tasks done and reach their goals – also when the deadline is tight.

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OUR EXPERTISE WITHIN QA

Below are examples on types of tasks that we have solved

OVERVIEW

  • Gap-analysis: Going through systems and processes to outline how far away your company are from being in compliance?
  • Action plan with concrete solutions of possible unresolved issues, to get in compliance – what does it take?
  • Introduction to existing legislation. Focus can be medicinal products, medical devices, food supplements or medicinal cannabis.
  • Guidance about consequences of new rules and requirements from the authorities – and what it means for the entire organization.
  • Professional sparring on different and possible decisions according to compliance and professional arguments (pros and cons).

QUALITY SYSTEM AND QUALITY ORGANIZATION

  • Managing processes and level of quality.
  • Establishing quality systems and optimizing existing solutions.
  • Development of a quality organization and responsible for selected roles according to quality management e.g. QP/PRRC/CP.
  • Audits and self-inspection.
  • Inspection support: Professional sparring before, during and after an inspection. Read more here.
  • Implement changes in the legislation, to make sure that the entire organization consider and use quality in their day-to-day tasks.

OPERATIONAL SUPPORT

  • Review of batch documentation.
  • Managing deviations, including dialogues with QA about defining a deviation.
  • Production support and trouble-shooting.
  • CAPAs and cases of change-control.
  • Composition and update of SOPs and other types of GMP-documentation.
  • Solutions of practical tasks before and after inspection of the authorities.

Do you want further information?

Let's talk about your company and the possibilities for a possible Cooperation.

CONTACT US ABOUT QA

Find solutions in compliance, with the help of AlfaNordic. 

Thomas Bo Sølver

Team Manager, QA

Subject areas
QMS/Product release
Audit and inspections
CMO/Supplier Management

+45 51 57 26 72
TBS@alfanordic.com

Saad Nisar

Team Manager, Production Support

Subject areas
Production Support
Deviation (NC), CAPA, CR/CC
GMP Documentation (Batch review, SOP etc.)

+45 31 44 75 43
SNIS@alfanordic.com

Lisbeth Bonde

Business Developer  

Subject areas
Customer contact
Offers and contracts
Follow-ups

+45 31 44 75 44
LIBO@alfanordic.com

LET'S GET STARTED

BOOK A CONSULTATION, FREE OF CHARGE 

Are you ready for changes? Let us talk about your company’s ambitions and how we can break through in a new country.

Get an idea of what we can offer, by participating in our inspiration meetings. Here our specialists share their knowledge and experiences.

MEET OUR SPECIALISTS - PARTICIPATE IN OUR INSPIRATIONAL MEETINGS

CONTACT US

Do you have any questions, or do you want to know more? Contact us. You can find our contact information below. We look forward to hearing from you.

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