CSV Systems and data
Computerized System Validation
Reliable systems. Data integrity. Defensible decisions. Validation means proving, with evidence, that a system does what it is supposed to do, protects critical data and is under control. We design risk-proportionate validations that cover the entire life cycle, from user requirements to system retirement.
Signals
When do you need it?
- You're implementing or migrating a systemLIMS, ERP, MES, QMS, CDS, SCADA or any software with GxP impact.
- There's been a significant changeA new version, new functionality, an integration or an infrastructure change.
- An audit raised observationsAudit trail, access, electronic signatures or incomplete documentation.
- You inherited legacy systemsThey were never validated, or their validation no longer reflects current use.
Approach
More than a regulatory requirement
A good validation isn't a stack of signed protocols. It's an argument: these are the requirements, these are the risks, this is how we tested them and this is the evidence. If one link is missing, the argument falls apart.
We follow the GAMP 5 Second Edition approach: critical thinking, risk-based effort and leveraging supplier documentation. Less useless paperwork, more evidence that holds up to questioning.
Validation isn't testing everything. It's testing what matters, and being able to explain why.
How we do it
Service stages
- URSRequirementsIntended use, user and regulatory requirements.
- RISKRiskFunctional risk assessment per ICH Q9 and GAMP category.
- FS/DSSpecificationVerifiable configuration and design.
- IQ·OQ·PQVerificationTests traced to every requirement.
- VSRReleaseReport, traceability and handover to operation.
Regulatory framework
What the regulations require, point by point.
These are the references we work with for this service. We apply the ones that fit your market and your type of product.
FDA United States
- 21 CFR Part 11Electronic records and signatures: audit trail, access controls and signature verification.
- 21 CFR 211.68Automatic, mechanical and electronic equipment: controls and backup.
- Computer Software Assurance (CSA)Risk-based testing approach grounded in critical thinking.
EU GMP EudraLex Volume 4
- Annex 11Computerized systems: risk, suppliers, validation, data, audit trail, change and continuity.
ISPE GAMP 5 Second Edition (2022)
- Categories 1, 3, 4 and 5Infrastructure, non-configured, configured and custom software. Each one has its own strategy.
- V-modelTraceability between specifications and verification.
PIC/S Inspectorates
- PI 011-3Good practices for computerized systems in regulated GxP environments.
- PI 041-1Data integrity: ALCOA+ and data governance.
ICH Harmonization
- ICH Q9(R1)Quality risk management as the basis for validation scope.
LATAM Local authorities
- ANMAT Disposition 4159/2023GMP for manufacturers, with a dedicated annex on computerized systems.
- ANVISA RDC 658/2022GMP for medicinal products: computerized system validation.
Deliverables
What you get.
Inspection-ready documentation, fully traceable and in your format. And a team trained to maintain it.
- Validation Plan (VP) or VMPStrategy, scope, roles, acceptance criteria and risk approach.
- URS / FS / DS specificationsUser, functional and configuration or design requirements.
- Functional risk assessmentCritical functions, controls and justified test depth.
- Executed IQ / OQ / PQ protocolsTest cases with objective evidence and deviation management.
- Requirements traceability matrix (RTM)Every requirement linked to its test and result.
- Validation summary report (VSR)Formal conclusion and release of the system for GxP use.
- Part 11 / Annex 11 assessmentAudit trail, electronic signatures, access, backup and archiving.
- Plan to maintain the validated stateChange control, periodic reviews and revalidation.
FAQ
What clients ask before we start
How long does a validation take?
It depends on the GAMP category, the number of critical functions and the supplier documentation available. After the initial assessment we give you a firm schedule.
Are validation and qualification the same thing?
No. Qualification (IQ/OQ/PQ) is executing tests. Validation is the complete life cycle strategy: requirements, risk, testing, traceability and ongoing control.
Can you leverage the supplier's documentation?
Yes, and that's what GAMP 5 recommends: we assess the supplier and reuse their testing when appropriate, so effort isn't duplicated.
Do you work with cloud (SaaS) systems?
Yes. We tailor the strategy to shared responsibilities, quality agreements and the supplier's change controls.
Works well with
Related services
-
QA·IT
IT quality management
Without an inventory, criticality and QA IT policies, every validation starts from scratch.- GxP inventory
- GAMP 5
- PIC/S PI 011-3
-
XLS
Excel spreadsheet validation
Spreadsheets that calculate results, yields or stability and that nobody has validated.- GAMP 5
- 21 CFR Part 11
- EU GMP Annex 11
-
DRP
Disaster recovery (DRP)
Cyberattacks, outages or infrastructure failures that can bring the plant to a halt.- ISO 22301
- ISO/IEC 27031
- EU GMP Annex 11 §16
Next step
Be ready for your next
regulatory challenge.
Tell us what you need to validate, qualify or document. In the first conversation we get to know your operation and tell you how we would approach it.