Validation

welcome to Nordika

FOR THE GOOD OF ALL, PERFORMOUR UTMOST
TO THE WORLD OF ADVANCED ENGINEERING

At Nordika we have technology and knowledge to develop Commissioning & Qualification activities with Risk and Science Based Approach reducing the test efforts and resources utilization.

User Requirements Specifications

Our knowledge shared to develop the key elements of your URS.

Design Review/ Qualification

Your project evaluated by Nordika subject matter expert team to assure URS accomplishment.

Quality Plan for Construction Management

Strategic Quality Plan development to assure that equipment and systems are installed and released in compliance with safety and functionality requirements and according to the intend of use.

Request for Proposal Review/ Quality Agreements

Our experts assuring that key elements will be received in the Databook, material will be received according to Specifications and Deliverables & Milestones will be alignment with payment.

FAT/SAT Protocols

Our experts checking equipment and systems protocols from suppliers and tests oversight.

Construction Material receipt control, storage and release

Our experts checking equipment and systems receipt and release for construction.

Construction checklist

Construction inspection.

Daily walk downs at site to check activities.

Photographic report with observations.

KPIs (% of verifications).

Punch list control

Pending items sorted by system, supplier, area, equipment and contractor.

Deliverable control with responsible and dates definition.

Classification according to risk for safety and functionality.

Prioritization according to impact on schedule and C&Q.

Mechanical Completion

Documented Turnover from Construction to Commissioning:

MC certificate: Assure construction is completed, TAGs implemented at field and maintenance controls, Tests to be done during construction completed, Databook and As Builts received and properly stored.

C&Q Plan

Documented plan following ISPE guideline for system classification according to direct impact on product quality.

Commissioning and Acceptance Tests

Our experts checking the facilities, equipment and systems installation and operation to
assure they are suitable for the intend of use, and in compliance with safety
and functionality requirements. Documented Handover from Commissioning to End User.

Risk Management

Our expects to facilitate the Scientific Quality Risk Management implementation, including Strategic Control of Contamination, CPPs and CQAs identification, based on ICH Q9R1. Using Ishikawa and FMECA tools

Qualification (IQ/ OQ/ PQ)

Our professionals supporting you to qualify your equipment & utility, according to IN n° 138/22 ANVISA.

Computer System Validation

Our experts supporting you to assure data integrity and GAMP5, CFR 21 Part 11, IN n° 134/22 ANVISA’s requirements accomplishment.

Cleaning Validation

Scientific risk approach.

Worst case identification.

CIP/ SIP/ COP and Manual cleaning process validation.

Technological Transfer Plan and Process Validation

Our professionals supporting you to identify CPP, test plan and analysis and documented process results.

Analytical Method Validation

Our professionals supporting you to classify your analytical methods and propose the correct tests to be done to assure the Method validation.

Audits

Our team supporting you to achieve GMP compliance on ANVISA or PIC/S Annex 1.

Supplier Qualification

Our professionals supporting you to certify your suppliers (GUT tool).

Training and Quality System

Our experts sharing their knowledge with your staff and developing your standards and procedures.

Brazil Headquarters

Avenida Queiroz Filho, 1700 – Torre A Conj 807 – Vila

Hamburguesa, São Paulo – SP

Branch Office

Rua Tupinambás, 13 – Sala 910 – Melo, Montes Claros – MG

Denmark Headquarters

Vestervang 8, 3300 Frederiksværk