Computer System Validation

Validation and qualification of both on-prem and cloud computer systems is a crucial part of any validated and compliant environment to ensure quality and compliance. Regulatory constraints are wide-reaching and deep knowledge and up to date awareness of all CSV strategy, IQ, OQ, PQ, risk-based validation, execution and reporting requirements are needed to ensure compliant operations. Zifo has extensive experience in this domain and experience with many different relevant frameworks such as risk-based validation methodologies, computer software assurance, GAMP5 based approaches.

Fast Moving Consumer Goods (FMCG)

Formulations and recipe development/management, product/market testing, process scale-up and manufacturing, PLM informatics
F&B

Ingredient development, product/recipe optimisation, formulation & process development, stability, manufacturing, PLM informatics.
Oil & Gas

Lab & testing operations, process analytical technologies (PAT), SCADA and remote plant monitoring informatics
PHARMA

Chem & Bio, Lab Informatics, Pharmacology, PK/PD, Safety/Tox, Formulations, Analytical, Manufacturing QC, Clinical Trials informatics support
Speciality Chemicals

Chemicals & Biomaterials, Process Development, Analytical method dev & test, Formulations & recipe dev & management, PLM informatics.

ABOUT COMPUTER SYSTEM VALIIDATION

CSV validation strategy, IQ, OQ, PQ development and qualification, risk-based validation, execution and reporting across 21 CFR part 11, GLP, GMP, GAM...

OUR CAPABILITIES

Our expertise spans the whole spectrum of scientific informatics, and we're able to draw on a huge marketplace of partnerships and experience with scientific software & technology platform providers. So whatever is needed we'll provide an agnostic, unbiased, impartial and tailored approach to determining the best way forward for your situation.

PEOPLE

Our people are our business and we invest in and support their development and curiosity. We actively promote science in our daily work and over 90% of people in ZIfo have a scientific background - meaning we speak & understand the language of science.

GLOCAL

We have a GLOCAL (global & local) presence - meaning we engage with you in your language and time zone but leverage a global delivery support model to remain cost-effective, scalable and very reactive.

FOCUS

We focus on science and scientific process applications and informatics. This means we can provide expertise and domain knowledge without compromising quality, technical and service delivery excellence.

PARTNERSHIPS

Our huge marketplace of partnerships with science technology and informatics platform providers means you can rely on Zifo to be agnostic and advise on strategy, plan & deliver projects, and validate and maintain your scientific informatics environments.

There is nothing to worry about with this study when we’ve you! No one is raising any issues with data management 😊 – Medium Pharma

That’s good. The implementation corresponds exactly to what we had discussed. Good work. 👏👍 – Medium Speciality Chemicals

You are a star 😊 That was quick, and I really didn’t expect my Friday would be so effective !! Large FMCG

Thank you! You guys are the best! Small CRO

SOME OF OUR AWARDS

Partners