VPS LATAM — Commercial Portfolio

vps-latam · commercial portfolio

Validation of Processes
and Software Latam S.A.S

GxP · CSV · GAMP 5

Commercial Portfolio

Colombia · LATAM

Regulated Industries

Precision. Compliance. Trust.

Computerized
Systems Validation
Experts

We help regulated organizations across Latin America achieve and maintain full GxP compliance — validating the digital systems that keep people safe.

CSV

Periodic Review

Spreadsheets Validation

Keep Quality

GxP Sheets

Outsourcing

Assessment

About VPS LATAM

Who We Are

02 / 10

About Us

Dedicated Expert in
Computerized Systems
Validation

Founded in Colombia and serving regulated companies across Latin America, VPS LATAM combines deep technical expertise with practical regulatory knowledge to keep your critical systems compliant, efficient, and audit-ready.

10+

Years of Experience

Specialized in GxP computerized systems validation

40+

Clients Served

Pharmaceutical, biotech, food, medical devices

100%

Compliance Focus

Every engagement built on regulatory rigor

Why VPS LATAM

Our Differentiators

03 / 10

What Sets Us Apart

Three Reasons
to Choose VPS LATAM

01

International
Expertise

We apply global standards — FDA 21 CFR Part 11, EU Annex 11, GAMP 5, and ICH guidelines — while navigating the regulatory nuances of INVIMA, ANMAT, ANVISA, and other LATAM health authorities.

FDA · EMA · ICH · GAMP 5

02

Full-Lifecycle
Coverage

From initial assessment to periodic review, we support every phase of a system's validated life — reducing the compliance burden on your internal team.

Assessment → Validation → Review

03

Proven
Technology

Our proprietary platforms — Keep Quality and GxP Sheets — are built for regulated environments, reducing validation effort while increasing traceability.

Keep Quality · GxP Sheets

Service Portfolio

6 Specialized Services

04 / 10

What We Offer

Our Service Portfolio

01

Computerized Systems
Validation

Full IQ/OQ/PQ validation of GxP-critical computer systems following GAMP 5 methodology.

GAMP 5 21 CFR Part 11 Annex 11

02

Periodic
Review

Scheduled compliance assessment and revalidation management for systems already in validated state.

Risk-Based Documentation

03

Spreadsheets Validation
& Implementation

Design, validation and implementation of GxP-compliant spreadsheets — including advanced macro development for regulated workflows.

Data Integrity Excel / Sheets Advanced Macros

04

Tech Compliant
Solutions

Proprietary software platforms: Keep Quality for CSV lifecycle management and GxP Sheets for compliant spreadsheets.

Keep Quality GxP Sheets

05

Outsourcing

Embedded validation specialists on flexible engagement models — scalable regulatory capacity on demand.

On-Site / Remote Flexible

06

Assessment

Gap analysis and compliance readiness evaluation — including audit preparation and a prioritized remediation roadmap.

Gap Analysis Audit Prep

Service 01

Computerized Systems Validation

05 / 10

Service

Computerized
Systems
Validation

01

Core Service

Validate Your
Critical Systems

We deliver complete validation of GxP-critical computer systems — from ERP and LIMS to manufacturing execution systems — following a structured, risk-based approach aligned with GAMP 5 and international regulations.

Installation, Operational and Performance Qualification (IQ / OQ / PQ) protocols

Validation plans, User Requirements Specifications and Validation Reports

Compliance with 21 CFR Part 11, EU Annex 11, and GAMP 5 Category 3, 4 & 5 systems

GAMP 5 21 CFR Part 11 EU Annex 11 IQ / OQ / PQ Risk Assessment INVIMA

Services 02 & 03

Periodic Review · Spreadsheets Validation

06 / 10

02

Periodic
Review

Maintain the validated state of your systems over time with structured, risk-based periodic reviews that keep you audit-ready year-round.

Evaluation of change controls, deviations, and system evolution

Updated Validation Summary Reports and traceability matrices

Revalidation scope definition and scheduling

Change Control Revalidation Traceability

03

Spreadsheets
Validation &
Implementation

Excel-based spreadsheets carry significant data integrity risk in regulated environments. We design, validate and implement them compliantly from day one — including custom advanced macros for complex regulated workflows.

Custom validation protocols for spreadsheet tools

Advanced macro development (VBA) validated under GxP requirements

Functional testing, access controls, and audit-trail design

Data Integrity Excel Advanced Macros 21 CFR Part 11

Service 04

Tech Compliant Solutions

07 / 10

Proprietary Software

Tech Compliant Solutions

Product 04-A

Keep
Quality

A platform built specifically for managing the full Computerized Systems Validation lifecycle — from URS to Validation Summary Report — in one traceable, compliant environment.

Centralized validation documentation repository

Workflow management for IQ / OQ / PQ execution

Electronic signatures and full audit trail (21 CFR Part 11)

Product 04-B

GxP
Sheets

Pre-validated, ready-to-use compliant spreadsheet templates for regulated environments — dramatically reducing the time and effort to deploy GxP-compliant Excel tools.

Pre-built spreadsheet templates with embedded controls

Validation package included: VP, FRS, URS, protocols

Accelerates spreadsheet validation by up to 70%

Services 05 & 06

Outsourcing · Assessment

08 / 10

05

Outsourcing

Extend your validation team without the overhead of full-time hiring. Our specialists integrate directly into your organization — on-site or remote — scaling capacity exactly when you need it.

Dedicated CSV specialists embedded in your QA team

Flexible engagement: project-based or ongoing retainer

On-site, hybrid, or fully remote delivery models

On-Site Remote Flexible Engagement

06

Assessment

Know where you stand before the auditors arrive. Our assessment service provides an honest, expert picture of your current validation posture — and a clear path to close the gaps.

Gap analysis against current regulatory expectations

Prioritized remediation roadmap with effort estimates

Audit preparation and mock-inspection support

Gap Analysis Audit Prep Roadmap

Our Clients

Regulated industries across LATAM

09 / 10

Proven Track Record

Trusted by 40+ Companies
Across Latin America

Pharmaceutical · Biotechnology · Medical Devices · Food & Beverage · Laboratories · Universities

Let's Work Together

Ready to
Validate Your
Path to Compliance?

Let's start with a conversation. Tell us about your systems, your regulatory challenges, and your timeline — we'll design the right engagement for you.

🌐 www.vpssas.com

📧 jospina@vpssas.com

📍 Bogotá, Colombia · Inspire trust and drive change

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