Validation

Experienced and professional experts

AlfaNordic’s Validation consultants

At AlfaNordic, quality is paramount and we understand the importance of the qualification and validation work which in the final analysis is about patient safety. Our work is based on a risk-based approach to qualification/validation with a systematic assessment of the task, so focus is aimed at the aspects of the validation that might have a critical impact on the product. You as a customer will, to a higher degree, be able to argue for the product safety in your discussions with the authorities. We have in-depth knowledge of the pharmaceutical and biotechnological industry and meet our customers where they are. Our customers will meet experienced and professional validation consultants who are able to step in directly as a worthy sounding board.

Validation of temperature controlled room and equipment

Get to know AlfaNordic's lean based validation service
High quality and time-saving overview - AlfaNordic has developed a cost-effective consulting service within validation.
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We can help with our broad experience

Qualification and validation take up a lot of space and require extended efforts in the pharmaceutical production, it is therefore natural that this discipline constitutes a larger part of AlfaNordic’s many competencies. We offer our customers support within qualification and validation of facilities, equipment, processes (API, Aseptic, Packing), cleaning validation and IT/automation. We perform tasks for our customers with short notice within projects of a shorter or longer duration. Our skilled employees offer assistance with or performs validation management (Project Management), planning, design, practical execution of validations and assessment of existing validations. We can lead, perform reviews and perform Quality Assurance (also in the role of QA) or we ourselves can prepare the necessary documentation during the product’s entire lifecycle, or during part of it.

We offer validation

Validation and qualification are performed on facilities, equipment, processes (API, aseptic, packing, cleaning validation and IT / Automation. We assist with PQ and PV as well as Cleaning Validation. We can lead, perform reviews and perform Quality Assurance or we ourselves can prepare the necessary documentation.

The following are examples of our expertise within validation:

Requirement Traceability Matrix (RTM)

As an essential part of a successful validation, it is necessary to secure traceability of URS requirements to the validation documentation – an RTM is drawn up for this and this RTM is thus the backbone of the coming validation.

Validation Master Plan / Validation Plan (VMP/VPL)

In order to secure a smooth validation, a validation plan must be drawn up for the project, – that is, a description of the roles and responsibilities of the different ”stakeholders” throughout the project.

Design and Installation Qualification (DQ/IQ)

The purpose of the DQ is to make sure that the chosen solutions fulfil the specified requirements. The process entails involvement by supplier/QA and the user. The Installation Qualification is a controlled method with a protocol, test plans a report that demonstrate fulfilment of the installation requirements.

Operational and Process Performance Qualification (OQ/PPQ)

A controlled method for demonstrating fulfilment of functional requirements and performance requirements. The method will ensure that requirements from the URS via the RTM are tested according to a protocol with several test plans that are subsequently consolidated in a report. This will form the basis for the final approval of a piece of equipment.

Process Verification (PPQ/PV)

A controlled method for demonstrating fulfilment of process and product requirements. The method will ensure that the requirements from the URS via the RTM are tested according to a protocol with several test plans that are subsequently consolidated in a report. This will form the basis for the final approval of a process.

Why us?

We are a specialized consulting department within AlfaNordic, serving the pharmaceutical and biotechnology industry. We feel able to compete with companies with much bigger size for the following reasons:

Controlled growth and increasing efficiency are often the key to a company's success and profitability. These goals are just as often the company's main priorities, but can be reduced or disappear by daily disruptions of inadequate and risky processes in administration and production. As a partner, AlfaNordic will be the best within the field. We evaluate the strategic risk and provide organisational advice to the entire value chain of your company.

Our sales and delivery process

1. Competency needs

The competence requirement for the desired task is described together with the customer. Possibly a sales meeting will be held. Contact AlfaNordic Sales or a Function Manager.

2. Proposal and review

AlfaNordic prepares presentations, time requirements and CVs for the task, as well as sends the presentation to the customer and goes through it. A possible meeting for further discussion of the presentation.

3. Contract

AlfaNordic submits a contract for approval by the customer. The contract includes financial information, named consultants and time consumption, as well as start and end dates.

4. Start of task

AlfaNordic's consultants start the task at the agreed time.

5. Continuous follow-up

AlfaNordic follows up on the consultants and holds regular status meetings with both the client and the consultants.

6. Completion of task and customer evalution

The task ends at the agreed time and with the agreed price. AlfaNordic follows up with a customer evaluation form and a final dialogue with the customer.

Contact our validation team

Mai-Britt Olafsson
Partner, Validering & QC
+45 5353 4378
Email
Rasmus Kriegel
Partner, Sales
+45 3144 7515
Email
en_US

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