GxP IT consultants and validation
dba consult finds freelance GxP IT consultants for validation, data integrity and compliance in pharma and life science: CSV and CSA, 21 CFR Part 11 and EU Annex 11, Veeva, MES, LIMS and QMS. We also staff related roles in regulatory affairs, QA and clinical compliance.
When IT systems must stand up to an inspection
In GMP-regulated environments, IT systems must be validated, data must be trustworthy and changes must be documented. That applies in production, laboratories, quality and clinical trials.
We start with the task. Which system and phase is it, what do GMP, FDA and the EU require in documentation, and who owns the validation? Together we clarify the role before you meet relevant profiles.
The pharma industry's large expansions and new plants increase the need for experienced people who can validate systems and secure data integrity from day one.
Competencies
From validation plan to inspection
Validation of IT systems (CSV and CSA)
Validation consultants for computer system validation (CSV) and computer software assurance (CSA) under GAMP 5: validation plan, risk assessment, requirements, testing and report. Also validation of AI in GxP environments.
Data integrity and audit trails
Consultants for data integrity (ALCOA+), audit trails and electronic signatures under 21 CFR Part 11 and EU Annex 11, and for system reviews before inspection.
Veeva and quality systems
Specialists in Veeva Vault for quality, regulatory and clinical data, and in QMS, document control, CAPA and change control.
MES and LIMS
Consultants for implementation, validation and operation of MES and LIMS in new and existing production lines and laboratories, also during upgrades.
Validated systems in cloud and ERP
Consultants for moving validated systems and ERP to cloud or to a new country, with infrastructure qualification and supplier assessment.
IT quality and compliance
IT QA for system changes, periodic review, deviations and audit. Validation planned across a whole company with a common method and templates.
Regulatory, QA and clinical compliance
Related roles we also staff with freelancers: regulatory affairs, QA and compliance, clinical compliance and pharmacovigilance.
Case stories
Assignments in validation and compliance
Assignments from our consultant network show experience with CSA, Veeva, MES, LIMS and data integrity in regulated environments.
Which assignment resembles yours?
Featured case
Validation under CSA
A pharma company needed to move from heavy CSV documentation to validation under CSA and at the same time validate an AI tool in a GxP environment.
The validation consultant set a risk-based approach, focused testing on what is critical and adapted templates and procedures.
Validation became faster and more targeted, and the documentation could stand up to inspection.
The task
Moving from CSV to CSA and validating AI in GxP.
Responsibility
Validation strategy and risk-based testing.
Expertise
CSA, GAMP 5, risk assessment and validation documentation.
Migration to Veeva Vault
A pharma company needed to bring quality, regulatory and clinical data together in Veeva Vault.
The consultant planned the migration, mapped the data and validated the system and the transfer.
Data was brought together in one validated system with a documented migration.
The task
Migration to Veeva Vault for quality, regulatory and clinical data.
Responsibility
Migration and validation.
Expertise
Veeva Vault, data migration and validation.
MES and LIMS in new production lines
A pharma company needed MES and LIMS in new production lines and validation of existing systems during upgrades.
The consultants worked on implementation, testing and validation and on the interfaces between MES, LIMS and automation.
The systems went live validated and ready for production.
The task
MES and LIMS in new production lines and upgrades.
Responsibility
Implementation and validation.
Expertise
MES, LIMS, automation and testing.
Data integrity and audit trails
A pharma company needed to secure data integrity and audit trails under Annex 11 and Part 11 and plan validation across the whole company.
The consultant reviewed the systems, closed gaps in audit trails and electronic signatures and set a common validation plan.
The company gained one overview of systems and validation and was stronger for inspection.
The task
Data integrity and a common validation plan.
Responsibility
Review, action plan and planning.
Expertise
ALCOA+, Annex 11, Part 11 and validation planning.
Validated systems moved to cloud
A pharma company needed to move validated systems and ERP to cloud and to a new country without losing the validated state.
The consultant qualified the infrastructure, assessed the supplier and planned the migration and testing.
The systems were moved and remained validated after the move.
The task
Moving validated systems and ERP to cloud and a new country.
Responsibility
Qualification, migration and validation.
Expertise
Cloud qualification, supplier assessment and ERP migration.
The right experience for GxP
We staff across IT, quality and production, so validation is done by people who know both the systems and the requirements, with experience from GMP-regulated pharma production. We find experienced freelance consultants for short validation tasks and longer programmes and aim to present a relevant candidate within 48 hours once the task is clear.
Validation is more than testing. It matters whether the consultant has been through an inspection and knows the difference between what must be documented and what is simply good practice. When the task includes production and automation, we look at the link to pharma and life science.
Contact
Let’s talk about your project
Do you need to staff validation, data integrity or compliance? Talk to Claudio about the task and which skills are needed.
Request a consultant or a meetingGet a reply within 48 hours.
Questions and answers
What clients often ask
Can you provide consultants for CSA instead of CSV?
Yes. We find consultants with experience in risk-based validation under CSA and GAMP 5.
Do your consultants have inspection experience?
Yes. We look at experience with inspections and audits when we assess a consultant.
Can you staff regulatory and clinical compliance?
Yes. We also staff regulatory affairs, QA, clinical compliance and pharmacovigilance.
Can you help clarify the need before we choose a consultant?
Yes. We start from the system and phase and help describe the role.
How quickly can you find a consultant?
We aim to present a relevant candidate within 48 hours once the task is clear.