Pharmaceutical validation and compliance
Your business never stops.
We validate systems, spreadsheets, processes, equipment and areas for the pharmaceutical industry, and we build the software that simplifies what is still done by hand. With the judgment of people who worked on the inside, evidence that stands up to inspections, and a plan to keep operations running no matter what.
- 20+ years in the pharmaceutical industry
- ANMAT · ANVISA · EMA · FDA
- GAMP 5 · Part 11 · Annex 11
- 21 CFR Part 11
- 21 CFR Part 211
- EU GMP Annex 11
- EU GMP Annex 15
- EU GMP Annex 1 (2022)
- GAMP 5 Second Edition
- ICH Q9(R1)
- ICH Q10
- PIC/S PI 011-3
- PIC/S PI 041-1
- ISO 14644
- ISO 22301
- ISO/IEC 27001
- ANMAT Disposition 4159/2023
- ANVISA RDC 658/2022
- WHO TRS
Services
What do you need to solve?
Eight service lines in three families. Each one starts by understanding your operation and ends with evidence your team can defend on its own.
Systems and data
So every GxP system, spreadsheet and data point is reliable and defensible, and repetitive work gets automated.
-
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
-
CSV
System validation (CSV)
LIMS, ERP, MES, SCADA or QMS that must prove they do what they claim.- GAMP 5 Second Edition
- 21 CFR Part 11
- EU GMP Annex 11
-
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
-
DEV
Software development
Manual tasks, endless spreadsheets and processes that eat up your team's hours.- Custom software
- Automation
- Smart Inventory
Processes, areas and equipment
To prove that your plant and your processes do what they are supposed to do, every time.
-
PV
Process validation
Manufacturing processes that must demonstrate consistent results, batch after batch.- FDA PV Guidance 2011
- EU GMP Annex 15
- ICH Q9(R1)
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C&Q
Qualification, mapping, FAT and SAT
New equipment, cleanrooms, warehouses and cold rooms that need to be qualified.- ISO 14644
- EU GMP Annex 1
- EU GMP Annex 15
Documentation and continuity
So operations are written down, understood and ready for the unexpected.
- +20years working inside the pharmaceutical industry
- 8service lines, from the supplier's factory to the software that automates
- 47concrete capabilities in our service catalog
- 4reference authorities: ANMAT, ANVISA, EMA and FDA
#SomosPharma
Pharmaceutical industry. Experience from the inside.
We don't work for the pharmaceutical industry: we are part of it. We've worked in production, quality control, quality assurance, IT and validation. That's why we design solutions that work on Monday morning, not just on inspection day.
Catalog
Everything we can do.
47 concrete capabilities: assessment, documentation, on-site execution and training.
Explore the full catalog- GxP computerized system inventory
- QA IT life cycle policies
- Validation Master Plan (VMP)
- System IQ / OQ / PQ protocols and execution
- Validation report and GxP release
- Validation of spreadsheets with formulas, macros and VBA
- Custom software development for identified processes
- DRP Smart Inventory: GxP laboratory inventory
- Process validation protocols (PPQ)
- Continued process verification program
- IQ / OQ / PQ of equipment and utilities
- Statistical analysis of mapping data (hot/cold spots)
- Document coding system and hierarchy
- Document Control Procedure
- Business impact analysis (BIA) with RTO and RPO
- Recovery drills and testing
- GxP criticality classification and GAMP 5 category
- Change, incident, access and backup procedures
- URS, FS and DS specifications
- Requirements traceability matrix (RTM)
- Periodic review and revalidation
- Formula protection, versioning and access control
- Automation of repetitive tasks and reports
- Validation-ready development documentation (GAMP 5 Cat. 5)
- Sampling plans and acceptance criteria
- FAT at the supplier's plant
- Cleanroom classification (ISO 14644 · Annex 1)
- Qualification Plan and periodic requalification
- Master SOP template
- Document management training
- Backup and recovery strategies
- Response team training
- Critical data flow mapping (ALCOA+)
- Inspection readiness for systems
- Functional risk assessment (ICH Q9)
- Part 11 / Annex 11 assessment: audit trail, signatures and access
- Spreadsheet inventory and GxP impact assessment
- Change control for validated spreadsheets
- Tools to organize and consolidate scattered data
- Identification of critical parameters and attributes (CPP/CQA)
- Statistical framework and process capability
- SAT at your site
- Temperature mapping of warehouses, cold rooms and areas
- Documentation gap analysis against GMP
- Writing SOPs, work instructions and forms
- IT risk and vulnerability assessment
- Documented Disaster Recovery Plan
Method
How we work
Five steps we follow on every project, whether it is a system, a spreadsheet, a cleanroom or a procedure.
- 01
Understand
We assess the process, system or area with the people who use it. Before writing a single document, we understand how the work actually gets done.
- 02
Assess the risk
We apply ICH Q9 to decide where the effort should go. Validating everything with the same intensity is expensive and adds no safety.
- 03
Design the strategy
We define scope, deliverables, acceptance criteria and owners. Everything is agreed before execution starts.
- 04
Execute with evidence
Protocols, tests and records with full traceability. Every conclusion rests on objective evidence.
- 05
Transfer and sustain
Final report, training and a plan to maintain the validated state when something changes.
Markets
One standard, four authorities.
We work to the requirements of the Argentine and Brazilian authorities, with EMA and FDA guidance as the international reference.
- ANMATArgentina
- Disposition 4159/2023 — GMP and computerized systems
- Inspections use EU GMP / PIC/S as the benchmark
- ANVISABrazil
- RDC 658/2022 — Good Manufacturing Practices
- Guidance on computerized systems
- EMAEuropean Union
- EudraLex Volume 4 — Annexes 1, 11 and 15
- Chapter 4 — Documentation
- FDAUnited States
- 21 CFR Parts 11 and 211
- Data Integrity and Process Validation guidance
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.