Services

Services

Sales activities internationally are handled through trained professionals available with our local agents appointed in various countries through out the world.

Additional support is also given through trained personnel from the Sales Department.

To help us to respond to your enquiry in the most efficient way, please use the link to our Contact Form.

  • Factory Automation
  • Regulatory Compliance Services
  • Computer System Validation

Factory Automation

Kevin is an Industrial Automation Solution Provider for the Life Sciences Industry. We are focused on providing Automation, Process & MES solutions to Life Science Industry across India.

Services Offered

  • PLC / SCADA based process & Turnkey Automation Control Solutions for Pharmaceutical, API, Sterile & Biotech industries.
  • Plant Wide SCADA Solutions
  • MES Solutions
  • PLC + HMI Based Equipment Automation
  • Building & Environment Control Systems
  • Integrated Panel


We have addressed various applications in Formulations / API / Biotech / Sterile areas of the Life Sciences industry like.
SCADA systems for production lines including batch production equipment. 
 

  • Energy Monitoring Systems
  • Bio Reactor Farm Automation
  • API Process Automation (Flame proof Areas)
  • Solvent Transfer Systems
  • Process Reactor Solutions
  • SCADA System for Lyophilized Freeze Dryer / Lyophilizer SCADA
  • Equipment Automation like FBD, RMG, Coater, Centrifuge, Autoclave, DHS, SIP, CIP, Distillation Column
  • ETP, RO Plant, Water Generation & Distribution System
  • Temperature, Humidity & Pressure Monitoring & Control
  • Overall Equipment Efficiency Projects (OEE)


Kevin is also an authorized & Certified Systems Integrator for Rockwell Automation.

The automation group has continuously built on its experience to bring you most advanced systems and instrumentation technology available today, while providing seamless compatibility with existing plant and operations.

Kevin offers Turnkey Automation solutions compliant to 21CFR Part 11 requirements in pharmaceutical industry. We undertake complete turnkey projects from basic to detailed engineering, system architecture, procurement, supply, installation, commissioning and validation. 

The company’s expertise in supporting a wide array of PLC and Software platforms including Rockwell Automation, Zenon, Omron, Siemens & many others, makes it easy for you to support your installations.

Our engineers are highly experienced in executing projects on various PLC platforms and in doing SCADA, PLC Control and Automation projects in various levels of the plant from machine to process Design, Supply, Installation, Commissioning of PLC Systems, Field Instruments, Control Valves and SCADA Systems.

Focus Industries

  • Life Sciences
  • CPG
  • Chemical
  • Edible Oil
  • Starch & Food Processing
  • Manufacturing Execution System


Why Kevin ?

  • Proven track record
  • Ready infrastructure
  • Competent skill set
  • Quality conscious approach
  • Experience of providing Solutions on Various PLC Platforms
  • Vendor Independent System Approach for delivering right solution to the customer
  • Professionally Managed & Experienced Project Team
     


Regulatory Compliance Services

Kevin Technologies is a leader in Regulatory Compliance & Validation Consulting & Services. Kevin also happens to be the pioneer for Regulatory Compliance Services in India & the largest company that provides Software & other GAMP based validation consulting in India & abroad. 

We have the knowledge and experience to help the customers assess and define their compliance and validationrequirements. Our portfolio of services encompasses the entire product life cycle and includes GAMP ComplianceServices, Software Testing & Validation and projects requiring the integrated services of both these services. 

Our dedicated pharmaceutical and computer systems division are uniquely qualified to optimize any validationeffort by applying quality validation services and the most current technology. 

Our knowledge and experience in the life Science Industry, along with in-depth understanding of GAMPguidelines provides added value for our clients. 

 

Services Offered

  • Validation of ERP & Manufacturing Execution Systems (MES)
  • Validation of LIMS (Laboratory Information & Management Systems)
  • Network Validation
  • Validation for other manufacturing automation systems such as Building Management Systems, Track & Trace Systems.
  • Validation of PLC & DCS based control systems as per GAMP & 21 CFR part 11
  • Comprehensive GAP & RISK Analysis for PLC & DCS based control systems as per GAMP
  • Retrospective Validation of legacy systems 

 

Our Strengths

  • Over 15 years of experience in the area of Computer System Validation & Regulatory Compliance Consulting.
  • Trained & highly experienced team for consulting & validation.
  • Executed thousands of validation procotols.
  • Experience of having worked with most & major pharmaceutical companies in India as well as assisting a lot of these companies for various audits, related to the CSV.
  • A strong & efficient back office team to support a huge team of on-site validation team members.

 

Data integrity

Data integrity refers to maintaining and assuring the accuracy and consistency of data over its entire life-cycle and is a critical aspect to the design, implementation and usage of any system which stores, processes or retrieves data.

As per MHRA:

The extent to which all data are complete, consistent and accurate throughout the data lifecycle. From initial data generation and recording through processing (including transformation or migration), use, retention, archiving, retrieval and destruction.

As per USFDA

For the purposes of this guidance, Data Integrity refers to the completeness, consistency and accuracy of data.

Complete, consistent and accurate data should be attributable, legible, contemporaneously recorded, original or a true copy and accurate (ALCOA).

General Root Cause : Data Integrity

  • Performance & business pressure
  • Lack of awareness or capability
  • DI not fully integrated into Culture
  • Inadequate processes & technology

General Expectations

  • Clear Understanding of Computerized System Validation (CSV)
  • Availability of policies and procedures
  • V-Model Approach (Including URS, FDS, RA, Testing) as per software categorization
  • Requirement of Test Evidence

Risk Based Approach covering the critical portion of Data Integrity

Configuration of systems - GxP function wise

  • Logical Security
  • Individual User(s)
  • Isolation of duties as per levels

Our advance Automation and validation solution provide powerful tools to the life science indutries to amke smooth transition from conventional to morden automated system which generate, transfer, maintain and capture original legible DATA with accuracy, completeness and consistency.


Computer System Validation

Kevin, one of the charter sponsors for ISPE in India, is the largest company in India, providing consulting & services in the area of regulatory compliances. We are the pioneers of Validation services in India and we offer various services to major Pharmaceutical companies across the globe 
 

Kevin has more than 14 years and thousands of systems in validation experience.Kevin has the knowledge and experience to help the customers assess and define their compliance and validation requirements. Our portfolio of services encompasses the entire product life cycle and includes GMP Compliance Services, Validation Services and projects requiring the integrated services of both these services.

Our dedicated pharmaceutical and computer systems division are uniquely qualified to optimize any validation effort by applying quality validation services and the most current technology.

Kevin is the only company providing below services

  • Comprehensive GAP & RISK Analysis
  • Most appropriate & latest GAMP, 21 CFR Part 11, EU Annex 11  guideline based Compliance services for your new / legacy systems
  • Validate Laboratory Equipment Software, IT systems, Network validation as per GAMP
  • Validate Building Management & Environment Control Systems
  • Validate DCS / SCADA / PLC Based Systems
  • Database Systems including ERP such as SAP & LIMS
  • Equipment validation
  • Validation Health Checkup for existing customers
  • Technical support during regulatory compliance audits

Highlights

  • Trained & Experienced Engineers for carrying out validation activity.
  • Experience of having worked with more than 50 major pharmaceutical companies in India and assisting them for International Audits.