Unannounced inspections
AEMPS, EMA, or FDA request full traceability for a specific change. Reconstructing it manually takes weeks and a signature is always missing.
Laboratories, manufacturing, and distribution
GRC software for the pharmaceutical sector
System validation, data integrity, process risks, and GxP audits on a single platform. When the inspection arrives, the evidence is already where it needs to be.
Everything they demand from you today, preloaded and linked together
What we hear in the sector
The pharmaceutical sector challenges we hear about every week
The problem isn’t knowing the obligations: it’s being able to prove at any time that you comply, without repeating the same work over and over again.
Never-ending system validation
Each computerized system carries its own validation file in different folders, with revisions that no one knows are current.
Quality, security, and compliance in parallel
The quality system goes one way and information security another, even though they share the same processes and providers.
GlobalSuite® in your organization
One platform. The answers they’re going to ask you for.
Everything shares the same inventory of processes, assets, controls and third parties. You update once and it’s reflected in risk, compliance, continuity and audit.
Quality risk, with the same rigor as financial risk
Risk assessment by process, equipment, and facility, with linked controls and CAPA actions that close when evidence arrives.
Taxonomy aligned with ICH Q9 and your quality system
Risks by process, equipment, facility, and provider
CAPAs linked to the originating risk
Full traceability of every change and approval
One control, all the frameworks that require it
Annex 11, 21 CFR Part 11, ISO 27001, and GDPR share controls. Provide evidence once and the status updates across all of them.
Pre-loaded GxP frameworks with their requirements
Live validation file per system
Reviewable and exportable audit trail
Inspection report generated from the platform
The AI reads the guide and your documentation. You approve.
We compare your procedures against the regulatory clauses and tell you what's missing, with the exact reference to the requirement.
Gap analysis on real documentation
Drafting proposal with reference to the requirement
Review of audit trails and deviations
Mandatory and traced human approval
Each role, its response
One platform each role makes their own
Everyone works on the same data, but each person comes in through their own door and sees what’s theirs. No duplication, no asking for it again.
Profile · Quality Management
The quality system, always ready for inspection.
Deviations, CAPAs, changes, and validations connected to the process map. Every piece of evidence has its date, author, and approval.
Traceable deviation and CAPA management
Change control with approval workflow
Validation file per system
Inspection report in one click
Their day-to-day in GlobalSuite®
RISKProcess and equipment risks
AUDITOpen and overdue CAPAs
COMPLIANCEGxP status per requirement
DOCUMENTSCurrent Procedures
The AI reviews your procedures and points out which GxP requirement has been left without evidence.
Profile · CISO
Protect the plant and the data, not just the office.
ISO 27001, NIS2, and OT security on the same asset inventory used by quality. No two versions of the truth.
Single inventory of IT and OT assets
Vulnerabilities with an owner and deadline
Production continuity and critical systems
Data integrity as a security control
Their day-to-day in GlobalSuite®
SECURITYMaturity by domain
RISKIT and OT risks
TPRMTechnology Providers
AUDITSecurity findings
The AI correlates security findings with the GxP processes that could be affected.
Profile · Compliance Officer
An obligation changes and you know who it affects.
Pharmaceutical regulation, privacy, and criminal compliance in the same matrix, with an owner and expiration date per obligation.
Multi-jurisdiction regulatory map
Whistleblowing channel and report management
UNE 19601 criminal compliance
Evidence ready for the auditor
Their day-to-day in GlobalSuite®
COMPLIANCEMulti-standard matrix
AIGaps detected
PRIVACYHealth data processing
AUDITOverdue obligations
AI for Compliance compares your documentation with the regulatory clauses and proposes the missing clause.
Profile · Internal audit
Internal and supplier audits in a single thread.
Annual plan, plant execution, findings, and follow-up connected to the universe of risks and controls.
Annual plan connected to the risk map
Digital Work Papers
Audits of manufacturers and suppliers
Follow-up of actions until closure
Their day-to-day in GlobalSuite®
AUDITAnnual plan coverage
AUDITFindings by criticality
TPRMSupplier audits
DOCUMENTSWorking paper evidence
The AI reviews evidence and controls before you do, and flags inconsistencies.
Frameworks and regulations
What they require from you here and there, in one place
Frameworks come preloaded with their controls and relationships. If you work across multiple jurisdictions, you manage a single matrix.
Quality and GxP regulation
GMP / GDP
Annex 11
21 CFR Part 11
ICH Q9
ALCOA+
ISO 13485
MDR / IVDR
FMD Serialization
Do you work with a framework that isn’t on the list? We’ll configure it with you. Tell us which one.
How we do it
Live in 3 to 6 months, not two years
We’re consultants as well as a vendor. We don’t leave you with an empty platform: we get it up and running with your risk model and your language.
WEEKS 1-3
Assessment and model
We review your risk taxonomy, your process map and the obligations that apply to you. No generic templates.
MONTH 1-2
Configuration
We configure modules, frameworks, approval workflows and role-based permissions. No custom development.
MONTH 2-4
Load and integration
We migrate your risks, controls, third parties and evidence. We connect SSO, directory and the sources you already use.
MONTH 3-6
Go-live
Role-based training, first real assessment cycle, and support through the first report to the committee.
Frequently asked questions
What we’re always asked before getting started
Is yours missing? Write to us and a person from the GRC team will reply, not a form.
TALK TO AN EXPERTIs the platform validated for GxP environments?
We support you in system validation within your environment: we deliver the qualification documentation and work with you on the protocol, with a full audit trail and electronic signature compliant with Annex 11.
Can I connect the LIMS, MES, and ERP?
Yes. Integration is done via API and preserves the traceability of the data source, so that the evidence remains valid for an inspection.
Can it also be used to audit my manufacturers and suppliers?
Yes. The third-party module manages the full cycle: questionnaires, due diligence, audits, and action follow-up, with the criticality you define.
Can we see your quality system within GlobalSuite®?
A 45-minute session with a consultant who knows GxP environments. You bring a real process and we show you how it would look.