Expertise
Eight services,
a single point of contact.
Aseptic equipment, with Bausch
Energy efficiency and green energyCommissioning, qualification and validation: every requirement written at the outset is verified, documented, then maintained over time.
Standards EMA-Annex 1 · GAMP 5 · 21 CFR Part 11 · FDA 2011 · ANSM 2015 · ICH Q9
Challenges we solve
01
The equipment has been delivered: now you have to demonstrate that it works as intended.
Let’s talk about this challenge
02
Processes, cleaning, sterilization: your validation must be done, or brought up to current guidance.
Let’s talk about this challenge
03
ERP, laboratory systems, building management: data integrity has to be demonstrated.
Let’s talk about this challenge
04
Calibration, maintenance, requalification: compliance has to hold over time.
Let’s talk about this challenge
We build the traceability matrix between the requirements (URS) and validation, then the Validation Master Plan (VMP). Next come commissioning (DQ, FAT, SAT), IQ and OQ of equipment, classified areas and laboratories, and temperature and humidity mapping.
We validate processes, cleaning and sterilization, computerized systems (CSV) and data integrity, and we set up metrology and predictive, systemic and preventive maintenance.
Qualification
The V-model
What is specified on the left is qualified on the right, and the traceability matrix links them, line by line.
Validation & verification between each specification and its qualification
URS · User requirements
What our team does: We write or review the URS with your teams, requirement by requirement, each one numbered so it can be traced.
Verified byPQ Performance qualification
URS · User requirements
What our team does: We write or review the URS with your teams, requirement by requirement, each one numbered so it can be traced.
Verified byPQ Performance qualification
FS · Functional specification
What our team does: We turn each URS requirement into functions that can be tested.
Verified byOQ Operational qualification
DS · Design specification
What our team does: We review the design (DQ) before fabrication, so nothing has to be fixed too late.
Verified byIQ Installation qualification
Construction · and installation
What our team does: We follow the factory (FAT) and site (SAT) acceptance tests, and the documentation that proves them.
At the heart of the VWhere specification turns into evidence
IQ · Installation qualification
What our team does: We write and execute the IQ protocols, then manage the deviations.
VerifiesDS Design specifications
OQ · Operational qualification
What our team does: We test every function, up to its limits and worst cases.
VerifiesFS Functional specification
PQ · Performance qualification
What our team does: We demonstrate performance over several batches, with your teams.
VerifiesURS User requirements specification
What you get
The traceability matrix, from requirements (URS) to validation
The Validation Master Plan (VMP)
Commissioning and testing (DQ, FAT, SAT)
IQ, OQ and PQ qualification of equipment, utilities, classified rooms and laboratories
Temperature and humidity mapping
Validation of processes, cleaning, sterilization and computerized systems
The calibration and maintenance program
The common core for every industry we serve.
Service sheet
CQV, CSV & maintenance
Page 1 of 1
Approved by
The PBE Expert team
Every industry adds its own requirements. Here is what comes on top of the common core, industry by industry.
Pharmaceutical2 items
Biotechnology and vaccines1 items
EU-GMP therapeutic and medical cannabis1 items
Hospitals and pharmacies3 items
Fine chemicals and APIs2 itemsIn practice
Frequently asked questions
FDA (2011) and ANSM guidance, with a risk-based approach (ICH Q9).
Yes, to GAMP 5 and 21 CFR Part 11: ERP, laboratory systems, building management and environmental monitoring.
Yes: warehouses, cold rooms and freezers, for temperature and humidity.
A new site, an expansion, an inspection to prepare for: describe your project and one of our experts will get back to you.
