Our Services

Qualification

Qualification & Validation

Qualification Support to meet your regulatory compliance

At Adam Fabriwerk, we understand the importance of validation. Our Quality Assurance team provides close assistance to our customers, throughout their validation cycle.

We have a dedicated, in-house Factory Acceptance Test (FAT) facility that is fully equipped with all the required utilities to ensure the systems that are ready are thoroughly tested and documented. Our QA team works closely with our clients to understand the validation and documentation needs and ensures the requisite support. Deviations are documented, attended to and cleared for inspection and shipment on approval.

Dedicated, fully equipped in-house FAT facility
Full support for system validation at site
Full support for all the documentation required

Our Quality Assurance team ensures delivery of all the required documents like test certificates, MOC, Drawings, P & ID, Weld certificates, Mill certificates, Calibration certificates etc., are compiled organized in an easy to retrieve format.

The QA team ensures full support for validation at the site and assists to qualify the system during installation as well as during the operation of the system.

Fully equipped

Factory Acceptance Test( FAT ) Facility

We at Adam Fabriwerk fully understand the need for a thorough evaluation to check if it is in accordance with the Design Qualification. That is why we have built a fully equipped world class facility to conduct the FAT.

High quality testing instruments ensure the systems work fine under the designed conditions. Our QA team ensures complete documentation that are required before and during the FAT while these tests are carried out.

GA & P&ID Verification

The system is verified against the approved GA and P&ID.

Bought out items

Bought outs installed are verified against the approved Design Qualification.

Surface roughness

The Ra value is measured at various locations on both the internal & external surfaces.

Hydrotest

Hydro test is conducted on all vessels to check for any leaks, as per SOP.

Mixers test

Mixers are run to ensure that the required mixing speeds are achieved.

Riboflavin test

Validates spray ball coverage. Performed using Riboflavin and verified using UV light.

Automation Checks

Automation cycles verified using water. Validates the functioning of logics.

Documentation Checks

To ensure all reports, protocols and certificates are as required for final qualification
Validation

Validation & Documentation Support

Our experienced Quality control team works together with you. You can rely on their experience to ensure faster system qualification without any delays.

Validation experience

Experience QC team ensures full documentation and qualification support

Deep Knowledge

Indepth knowledge of the regulatory landscape for Pharmaceuticals

Established Protocols

Over the years we have proven methods and established protocols

Qualified Team

Experienced quality control to support your validation efforts

Structured documentation

Our established processes ensure structured documentation

Precise Process controls

Enables prevention / mitigating risks of producing faulty batches

Functional Tests

Functional tests conducted on all critical instruments per specification

GMP Compliant template

All data captured in GMP compliant qualification template

We have considerable experience and expertise to enable you to achieve full compliance in the qualification of your systems