(CSV) Computer Systems Validation in GxP environments

Regulatory Requirements:
Pharma Lab, Clinical Research, BioTech, Medical Devices supplier,... are you subject to regulations FDA GxP, 21 CFR Part11, GAMP5, EU Annex11 ?

Need help and advice to design, manage and/or execute full Computer Systems Validation Projects, to keep systems under control, and to successfully pass an FDA-PAI Inspection, according to FDA GxP regulations, 21 CFR Part 11 , and the methodology GAMP5 Guide .

Do you want us to review and advise on your current Documentation and the situation of your Computer Systems in order to be able to face the start or follow-up of Validation with guarantees of regulatory compliance?

Do you have all the System Functional Documentation? Do you know if you have all the necessary PNTs defined? Corporate internal QA policy, IT technical documentation, Organization, Formats, Nomenclature, Coding of documents involved in Validation. Contact us, we will perform a GAP Analysis, and help and inform you of the REAL Situation, compared to the WANTED situation (required by FDA regulations) and see the differences, and be able to make appropriate decisions for your case.

GAP Analysis of the Documental Situation and Organization(prior to the execution of the System Validation):
Do you want us to review the current Documentation and situation of your Computer System to start the Validation? Find out if you have defined all the PNT's, User Requirements, Functional System Documentation, IT Technical Documentation, etc.
We will perform a GAP Analysis , and inform you of the actual situation, and see the differences with respect to the situation desired or required by applicable law, and you will be able to make decisions.

Implementation Consulting of Quality System Management(QMS) in Software Development:
Software Provider, you need to program under a Quality Development System (Quality Management System) that allows you to access regulated Industry Sectors (Pharma, Clinical Research, BioTech, Medical Devices), and know apply regulatory requirements?
What documentation should be generated? We advise how to Standardize Formats and Document Nomenclature to agree with other professionals and with the GxP and GAMP5 regulations.
He wants to design a Software Development Style Manual, define Standard Working Procedures (NPPs), to make all his technicians work in a unified and standard way. They want better time control (analysis, scheduling, testing, installation, technical support, documentation, etc.). And remember, we cover two areas: 1) we are Software Developers (we already know how to program it) and 2) we are experts in compliance FDA GxP, 21 CFR Part11 Electronic Registration and Electronic Signature, and < strong> GAMP5 (we already know how to validate this). Get the most out of our knowledge and experience.