THRIVE IT QUALIFY IT

COMMISSIONIN COMMISSIONING
AND QUALIFICATION (C&Q)

QIS offers full support along the Commissioning, Qualification and Validation Lifecycle (VLC) for your new or modified facilities, equipment, and systems. Our Commissioning & Qualification (C&Q) professionals are experienced in each deliverable from the C&Q portion of the VLC; i.e. the V-Model, as established by ASTM E2500 and ISPE‘s GAMP 5.

THRIVE IT QUALIFY IT

OUR PROMISE

Facilities Commissioning and Qualification

Qualification of Utilities and Critical Systems

Equipment Commissioning and Qualification (I/OQ)

QIS WILL PARTNER WITH YOUR ENGINEERING DEPARTMENT AND CONSTRUCTION FIRMS TO CREATE A LARGER WINNING TEAM AND EXCEED YOUR EXPECTATIONS

QIS will be your perfect partner, that‘s our promise. We will support your goals by delivering C&Q Services in the following areas:

CQV – Facilities /Utilities/ Equipment

Our CQV Team works with our clients to develop and implement their CQV strategy and offer various service delivery models which include:

Full project model – we create High-Performance Teams (HPT) to deliver end-to-end solutions (e.g. from project management to the specific CQV deliverables, including creation of forecast and service demand tools, and KPI selection and monitoring).

Staff augmentation model – we match your specific CQV need with any number of resources from our pool of CQV engineers while staying connected with both our resources and clients to monitor progress and assure project success.

Computer system validation provides documented evidence that software applications meet their intended uses by testing regulated functional processes as well as requirements related to electronic records and electronic signatures

Contact our specialists to tailor a service plan

Computer System Validation (CSV)

QIS has deliver specialized software testing services and validation solutions to Life Science companies to ensure compliance with applicable regulatory guidance required by the US Food and Drug Administration (FDA), UK Medicines and Healthcare products Regulatory Agency (MHRA), European Medicines Agency (EMA) and other international regulatory authorities.

Computer system validation, essential for competent risk management, improves product reliability, increases patient safety, and ensures the systems are running accurately within regulatory requirements. To maintain validation of your system in a time and cost-efficient manner, QIS – powered by follows a proven software testing process following GAMP 5 standards:

Assessment of critical needs
Project specifications with company approval
Objectives for each software testing phase
Testing script matrix for cross referencing all testing
Commercial and proprietary tools to execute testing
Report of comprehensive testing, including metrics of completeness
Maintenance of a validated state following updates

QIS – powered by

Registered office

Flat No.G2, Plot No: 21 Venkatarayanagar, Near Vignan School, Hyderabad, Telangana - 500090

+91 99080 91811

Contact :

www.qualifyitsolurions.com

Web

info@qualifyitsolurions.com

E-mail

Our Services

THERMAL VALIDATION SERVICES

Equipment Mapping
Scope

-80°C to 300°C

Masters

Data logger with sensor
Portable Data Logger

Equipment’s

Refrigerators
Deep freezer
BOD Incubator/ Bacteriological Incubator
Hot Air Oven/ Vacuum Oven
Auto clave (Horizontal/Vertical)
Tunnels
Lyophilizers
Muffle Furnace
Water bath
Walk-In- Stability chambers/ Cooling Chamber
Digital Hot Plate
Ultra-low Temperature Equipment Chamber
Clean Rooms Mapping
Thermal mapping Areas of Warehouse, Cold Room & Retention Room

Area Mapping
Scope

10°C to 50°C
RH 20%-95%

Masters

Portable Data Logger

Parameter

- Process area
- Ware house
- Walk-in cold rooms
- Walk-in Freezers

EQUIPMENT QUALIFICATION/ VALIDATION

COMPUTER SYSTEM VALIDATION