Qualification / Validation

We deliver outstanding Qualification / Validation services and products for the pharmaceutical and medical device industry according to cGMP standards. Quality Coordination and Agile Project Management of your life science projects are our core competency. What value does your project has without the necessary quality behind it? We strongly focus on quality solutions in the pharmaceutical and medical device industry. Our clients expect the best and we deliver it. Performance Qualifications of up to 300 pages speaks of the focus to detail we care for our clients and their processes. We prepare and bring your critical product Launches to success. Our focus is that you can operate your facilities and equipments to the best degree possible form a GxP standpoint to a productivity and LEAN view. We deliver Qualification and Validation services for Solids, Steriles, Biologics and Bio-similars. We focus on first time right, because you will always be faster and more economically with this approach, especially in the life science sector.

 

Our services in the field of Qualification / Validation:

  • Compliance and Engineering activities incl. Agile Project Management
  • Project Remediation and Restructuring
  • Project Qualification Planning, Coordination and Correction
  • Regulatory Deep Dive prior inspections incl. documentation check
  • Introduction of new products (drugs, devices or combination products)
  • Product launch activities incl. transfer from research and development to production and commercial release activities
  • New and complex Technology and Site Transfers
  • Computerized System Validation incl. Data Integrity
  • Quality Control Method Validation
  • Equipment Qualification
  • Process Qualification and Validation
  • Clean Room Qualification
  • Clean Media Qualification
  • Change Controls
  • Deficiencies and Deviations
  • Corrective and Preventive Actions (CAPA's)
  • Establishment and Review of Standard Operating Procedures (SOP's)
  • Commissioning

JUST THE MOST IMPORTANT THINGS FOR YOU

Master Qualification Plan (MQP)

Creation of Master Qualification Plan (MQP pages 1-20)

We create your Master Qualification Plan (MQP) with a volume of 1-20 pages based on our standardsDocument changes after first edition require additional work from your side on the document or can be purchased in our store. If you require more pages you have to upgrade the product.

 

Content:

  • Standard Master Qualification Plan (MQP) (in Word Format) pages 1-20
CHF 14 999.99 2

CHF 9 999.99

Creation of Master Qualification Plan (MQP pages >20)

We create your Master Qualification Plan (MQP) with a volume of >20 pages based on our standardsDocument changes after first edition require additional work from your side on the document or can be purchased in our store. If you require more pages you have to upgrade the product.

 

Content:

  • Standard Master Qualification Plan (MQP) (in Word Format) pages >20
CHF 26 999.99 2

CHF 19 999.99

User Requirement Specification (URS)

Creation of User Requirement Specification (URS pages 1-10)

We create your User Requirement Specification (URS) with a volume of 1-10 pages based on our standardsDocument changes after first edition require additional work from your side on the document or can be purchased in our store. If you require more pages you have to upgrade the product.

 

Content:

  • Standard User Requirement Specification (URS) (in Word Format) pages 1-10
CHF 6 999.99 2

CHF 4 999.99

Creation of User Requirement Specification (URS pages 11-25)

We create your User Requirement Specification (URS) with a volume of 11-25 pages based on our standardsDocument changes after first edition require additional work from your side on the document or can be purchased in our store. If you require more pages you have to upgrade the product.

 

Content:

  • Standard User Requirement Specification (URS) (in Word Format) pages 11-25
CHF 14 999.99 2

CHF 9 999.99

Creation of User Requirement Specification (URS pages >25)

We create your User Requirement Specification (URS) with a volume of >25 pages based on our standardsDocument changes after first edition require additional work from your side on the document or can be purchased in our store. If you require more pages you have to upgrade the product.

 

Content:

  • Standard User Requirement Specification (URS) (in Word Format) pages >25
CHF 26 999.99 2

CHF 19 999.99

Qualification Plan

Creation of Qualification Plan (QP pages 1-10)

We create your Qualification Plan (QP) with a volume of 1-10 pages based on our standardsDocument changes after first edition require additional work from your side on the document or can be purchased in our store. If you require more pages you have to upgrade the product.

 

Content:

  • Standard Qualification Plan (QP) (in Word Format) pages 1-10
CHF 6 999.99 2

CHF 4 999.99

Creation of Qualification Plan (QP pages >10)

We create your Qualification Plan (QP) with a volume >10 pages based on our standardsDocument changes after first edition require additional work from your side on the document or can be purchased in our store. If you require more pages you have to upgrade the product.

 

Content:

  • Standard Qualification Plan (QP) (in Word Format) pages >10
CHF 14 999.99 2

CHF 9 999.99

Functional Risk Analysis

Creation of Functional Risk Analysis (FRA pages 1-10)

We create your Functional Risk Analysis (FRA) with a volume of 1-10 pages based on our standardsDocument changes after first edition require additional work from your side on the document or can be purchased in our store. If you require more pages you have to upgrade the product.

 

Content:

  • Standard Functional Risk Analysis (FRA) (in Word Format) pages 1-10
CHF 6 999.99 2

CHF 4 999.99

Creation of Functional Risk Analysis (FRA pages 11-20)

We create your Functional Risk Analysis (FRA) with a volume of 11-20 pages based on our standardsDocument changes after first edition require additional work from your side on the document or can be purchased in our store. If you require more pages you have to upgrade the product.


Content:

  • Standard Functional Risk Analysis (FRA) (in Word Format) pages 11-20
CHF 14 999.99 2

CHF 9 999.99

Creation of Functional Risk Analysis (FRA pages >20)

We create your Functional Risk Analysis (FRA) with a volume >20 pages based on our standardsDocument changes after first edition require additional work from your side on the document or can be purchased in our store. If you require more pages you have to upgrade the product.

 

Content:

  • Standard Functional Risk Analysis (FRA) (in Word Format) pages >20
CHF 26 999.99 2

CHF 19 999.99

Design Qualification

Creation of Design Qualification (DQ pages 1-10)

We create your Design Qualification (DQ) with a volume of 1-10 pages based on our standardsDocument changes after first edition require additional work from your side on the document or can be purchased in our store. If you require more pages you have to upgrade the product.

 

Content:

  • Standard Design Qualification (DQ) (in Word Format) pages 1-10
CHF 6 999.99 2

CHF 4 999.99

Creation of Design Qualification (DQ pages 11-20)

We create your Design Qualification (DQ) with a volume of 11-20 pages based on our standardsDocument changes after first edition require additional work from your side on the document or can be purchased in our store. If you require more pages you have to upgrade the product.

 

Content:

  • Standard Design Qualification (DQ) (in Word Format) pages 11-20
CHF 14 999.99 2

CHF 9 999.99

Creation of Design Qualification (DQ pages >20)

We create your Design Qualification (DQ) with a volume >20 pages based on our standardsDocument changes after first edition require additional work from your side on the document or can be purchased in our store. If you require more pages you have to upgrade the product.

 

Content:

  • Standard Design Qualification (DQ) (in Word Format) pages >20
CHF 26 999.99 2

CHF 19 999.99

Installation Qualification

Creation of Installation Qualification (IQ pages 1-10)

We create your Installation Qualification (IQ) with a volume of 1-10 pages based on our standardsDocument changes after first edition require additional work from your side on the document or can be purchased in our store. If you require more pages you have to upgrade the product.

 

Content:

  • Standard Installation Qualification (IQ) (in Word Format) pages 1-10
CHF 6 999.99 2

CHF 4 999.99

Creation of Installation Qualification (IQ pages 11-20)

We create your Installation Qualification (IQ) with a volume of 11-20 pages based on our standardsDocument changes after first edition require additional work from your side on the document or can be purchased in our store. If you require more pages you have to upgrade the product.

 

Content:

  • Standard Installation Qualification (IQ) (in Word Format) pages 11-20
CHF 14 999.99 2

CHF 9 999.99

Creation of Installation Qualification (IQ pages >20)

We create your Installation Qualification (IQ) with a volume >20 pages based on our standardsDocument changes after first edition require additional work from your side on the document or can be purchased in our store. If you require more pages you have to upgrade the product.

 

Content:

  • Standard Installation Qualification (IQ) (in Word Format) pages >20
CHF 26 999.99 2

CHF 19 999.99

Operational Qualification

Creation of Operational Qualification (OQ pages 1-10)

We create your Operational Qualification (OQ) with a volume of 1-10 pages based on our standardsDocument changes after first edition require additional work from your side on the document or can be purchased in our store. If you require more pages you have to upgrade the product.

 

Content:

  • Standard Operational Qualification (OQ) (in Word Format) pages 1-10
CHF 6 999.99 2

CHF 4 999.99

Creation of Operational Qualification (OQ pages 11-20)

We create your Operational Qualification (OQ) with a volume of 11-20 pages based on our standardsDocument changes after first edition require additional work from your side on the document or can be purchased in our store. If you require more pages you have to upgrade the product.

 

Content:

  • Standard Operational Qualification (OQ) (in Word Format) pages 11-20
CHF 14 999.99 2

CHF 9 999.99

Creation of Operational Qualification (OQ pages >20)

We create your Operational Qualification (OQ) with a volume >20 pages based on our standardsDocument changes after first edition require additional work from your side on the document or can be purchased in our store. If you require more pages you have to upgrade the product.

 

Content:

  • Standard Operational Qualification (OQ) (in Word Format) pages >20
CHF 26 999.99 2

CHF 19 999.99

Performance Qualification

Creation of Performance Qualification (PQ pages 1-10)

We create your Performance Qualification (PQ) with a volume of 1-10 pages based on our standardsDocument changes after first edition require additional work from your side on the document or can be purchased in our store. If you require more pages you have to upgrade the product.

 

Content:

  • Standard Performance Qualification (PQ) (in Word Format) pages 1-10
CHF 6 999.99 2

CHF 4 999.99

Creation of Performance Qualification (PQ pages 11-20)

We create your Performance Qualification (PQ) with a volume of 11-20 pages based on our standardsDocument changes after first edition require additional work from your side on the document or can be purchased in our store. If you require more pages you have to upgrade the product.


Content:

  • Standard Performance Qualification (PQ) (in Word Format) pages 11-20
CHF 14 999.99 2

CHF 9 999.99

Creation of Performance Qualification (PQ pages >20)

We create your Performance Qualification (PQ) with a volume >20 pages based on our standardsDocument changes after first edition require additional work from your side on the document or can be purchased in our store. If you require more pages you have to upgrade the product.

 

Content:

  • Standard Performance Qualification (PQ) (in Word Format) pages >20
CHF 26 999.99 2

CHF 19 999.99

Qualification Report

Creation of Qualification Report (QR pages 1-10)

We create your Qualification Report (QR) with a volume of 1-10 pages based on our standardsDocument changes after first edition require additional work from your side on the document or can be purchased in our store. If you require more pages you have to upgrade the product.

 

Content:

  • Standard Qualification Report (QR) (in Word Format) pages 1-10
CHF 6 999.99 2

CHF 4 999.99

Creation of Qualification Report (QR pages 11-20)

We create your Qualification Report (QR) with a volume of 11-20 pages based on our standardsDocument changes after first edition require additional work from your side on the document or can be purchased in our store. If you require more pages you have to upgrade the product.

 

Content:

  • Standard Qualification Report (QR) (in Word Format) pages 11-20
CHF 14 999.99 2

CHF 9 999.99

Creation of Qualification Report (QR pages >20)

We create your Qualification Report (QR) with a volume of >20 pages based on our standardsDocument changes after first edition require additional work from your side on the document or can be purchased in our store. If you require more pages you have to upgrade the product.

 

Content:

  • Standard Qualification Report (QR) (in Word Format) pages >20
CHF 14 999.99 2

CHF 9 999.99

Master Qualification Report

Creation of Master Qualification Report (MQR pages 1-20)

We create your Master Qualification Report (QR) with a volume of 1-20 pages based on our standardsDocument changes after first edition require additional work from your side on the document or can be purchased in our store. If you require more pages you have to upgrade the product.

 

Content:

  • Standard Master Qualification Report (MQR) (in Word Format) pages 1-20
CHF 14 999.99 2

CHF 9 999.99

Creation of Master Qualification Report (MQR pages >20)

We create your Master Qualification Report (MQR) with a volume >20 pages based on our standardsDocument changes after first edition require additional work from your side on the document or can be purchased in our store. If you require more pages you have to upgrade the product.

 

Content:

  • Standard Master Qualification Report (MQR) (in Word Format) pages >20
CHF 26 999.99 2

CHF 19 999.99