At our company, we offer GAP assessment and compliance services to help our clients identify areas of non-compliance with regulatory requirements and implement corrective actions.
Our services include:
GAP Assessment: We perform GAP assessments to compare your existing processes and procedures with regulatory requirements such as 21 CFR Part 11, Annexure 11, ALCOA++, and other industry standards. Our team identifies any areas of non-compliance and provides recommendations for corrective actions.
Compliance as compared to 21 CFR Part 11, Annexure 11, ALCOA++: Our experts review your computer systems, software, and procedures to ensure they comply with FDA's 21 CFR Part 11 regulations, EU Annex 11, ALCOA++, and other relevant industry standards. We identify any areas of non-compliance and provide recommendations for corrective actions.
Compliance: Our team provides compliance services to help you ensure your computer systems and software comply with regulatory requirements. We offer compliance services for 21 CFR Part 11, Annexure 11, ALCOA++, and other industry standards. We are committed to providing our clients with comprehensive GAP assessment and compliance services to ensure they maintain compliance with regulatory requirements.
Contact us to learn more about our services and how we can help your organization ensure compliance.
- CSV Procedure
- IT Deviation and CAPA management
- Periodic Review
- IT SOPs
Welcome to our comprehensive computer system validation service, designed to meet the requirements of CSV, system life cycle process and procedure, IT deviation and CAPA management, periodic review, IT SOPs, and more. We have a team of experts who specialize in providing end-to-end solutions for validating computerized systems.
Our services include:
Validation of Manufacturing Systems We help our clients to develop a validation plan that outlines the validation strategy, scope, and approach for their computerized systems. Our validation plans are tailored to the unique needs and requirements of each client and are designed to meet regulatory requirements.
Validation of Manufacturing Systems We perform a range of testing and documentation activities to validate computerized systems, including functional testing, performance testing, user acceptance testing, and validation documentation. Our testing and documentation activities are designed to ensure that computerized systems operate reliably, accurately, and securely.
Validation of Manufacturing Systems We provide comprehensive IT deviation and CAPA management services, including identifying and documenting deviations from established procedures, implementing corrective and preventive actions, and managing CAPA records.
Periodic Review: We perform periodic reviews of computerized systems to ensure that they continue to operate reliably and accurately. Our periodic reviews include assessing system performance, identifying and addressing issues, and documenting review findings.
IT SOPs: We develop and implement IT SOPs that are tailored to the unique needs and requirements of each client. Our IT SOPs provide a clear and consistent approach to managing computerized systems and ensure that all activities are completed in a consistent and systematic manner.
We follow a rigorous quality assurance process to ensure that our services meet the highest standards of quality and compliance. We have deep expertise in compliance and regulatory requirements and can provide guidance on how to maintain compliance with the relevant regulations.
If you are looking for comprehensive computer system validation services, we are here to help. Contact us today to learn more about our services and how we can help you validate your computerized systems with confidence.
- Automated Manufacturing Equipment Control System Validation
- Validate DCS / SCADA / PLC Based Systems
- MES
- Serialization
Welcome to our comprehensive computer system validation service for manufacturing systems. We are specialist in providing end-to-end solutions for validating automated manufacturing equipment control systems, DCS/SCADA/PLC based systems, MES, serialization, and more. Our team of experts is dedicated to ensure your manufacturing systems operate reliably, accurately, and securely.
Our services include:
Automated Manufacturing Equipment Control System Validation: We provide comprehensive validation services for automated manufacturing equipment control systems, including functional testing, performance testing, user acceptance testing, and validation documentation. Our testing and documentation activities are designed to ensure that the equipment control systems operate reliably and accurately.
DCS/SCADA/PLC Based Systems Validation: We provide validation services for DCS, SCADA, and PLC based systems to ensure that they meet regulatory requirements and operate reliably and accurately. Our testing and documentation activities include functional testing, performance testing, user acceptance testing, and validation documentation.
MES Validation: We provide comprehensive validation services for Manufacturing Execution Systems (MES) to ensure that they operate reliably and accurately. Our validation services include functional testing, performance testing, user acceptance testing, and validation documentation.
Serialization Validation: We provide validation services for serialization systems to ensure that they meet regulatory requirements and operate reliably and accurately. Our testing and documentation activities include functional testing, performance testing, user acceptance testing, and validation documentation.
- FTIR
- Empower
- Incubator
- LIMS
Welcome to our computer system validation service for laboratory software. We are specialist in providing comprehensive validation solutions for various laboratory software applications such as FTIR, Empower, Incubator, LIMS, and more. Our team of experts is dedicated to ensuring that your laboratory software operates reliably, accurately, and securely.
Our services include:
FTIR Validation: We provide comprehensive validation services for FTIR software applications, including functional testing, performance testing, user acceptance testing, and validation documentation. Our testing and documentation activities are designed to ensure that your FTIR software operates reliably and accurately.
Empower Validation: We provide validation services for Empower software to ensure that it meets regulatory requirements and operates reliably and accurately. Our testing and documentation activities include functional testing, performance testing, user acceptance testing, and validation documentation.
Incubator Validation: We provide comprehensive validation services for incubator software applications, including functional testing, performance testing, user acceptance testing, and validation documentation. Our testing and documentation activities are designed to ensure that your incubator software operates reliably and accurately.
LIMS Validation: We provide validation services for Laboratory Information Management Systems (LIMS) to ensure that they meet regulatory requirements and operate reliably and accurately. Our testing and documentation activities include functional testing, performance testing, user acceptance testing, and validation documentation.
- Documentation
- SAP
- Learning Management system
- TrackWise
- ServiceNow
Our services include:
Documentation Validation: We provide comprehensive validation services for Documentation software applications, including functional testing, performance testing, user acceptance testing, and validation documentation. Our testing and documentation activities are designed to ensure that your Documentation software operates reliably and accurately.
SAP Validation: We provide validation services for SAP software to ensure that it meets regulatory requirements and operates reliably and accurately. Our testing and documentation activities include functional testing, performance testing, user acceptance testing, and validation documentation.
Learning Management System Validation: We provide comprehensive validation services for Learning Management systems, including functional testing, performance testing, user acceptance testing, and validation documentation. Our testing and documentation activities are designed to ensure that your Learning Management system operates reliably and accurately.
TrackWise Validation: We provide validation services for TrackWise software to ensure that it meets regulatory requirements and operates reliably and accurately. Our testing and documentation activities include functional testing, performance testing, user acceptance testing, and validation documentation.
ServiceNow Validation: We provide comprehensive validation services for ServiceNow software applications, including functional testing, performance testing, user acceptance testing, and validation documentation. Our testing and documentation activities are designed to ensure that your ServiceNow software operates reliably and accurately.
We follow a rigorous quality assurance process to ensure that our services meet the highest standards of quality and compliance. Our team has extensive expertise in compliance and regulatory requirements and can provide guidance on how to maintain compliance with the relevant regulations.
If you are looking for comprehensive computer system validation services for your enterprise software, we are here to help. Contact us today to learn more about our services and how we can help you validate your enterprise software with confidence.
- Server Qualification
- Cloud Qualification
- LAN/WAN Qualification
- Network component qualification
- Infra tools qualification (monitoring/Backup)
Welcome to our computer system validation service for infrastructure qualification. We specialize in providing comprehensive validation solutions for various infrastructure components such as servers, cloud platforms, LAN/WAN, network components, infrastructure tools, and more. Our team of experts is dedicated to ensuring that your infrastructure components operate reliably, accurately, and securely.
Our services include:
Server Qualification: We provide validation services for server hardware and software to ensure that they meet regulatory requirements and operate reliably and accurately. Our testing and documentation activities include functional testing, performance testing, user acceptance testing, and validation documentation.
Cloud Qualification: We provide comprehensive validation services for cloud platforms, including functional testing, performance testing, user acceptance testing, and validation documentation. Our testing and documentation activities are designed to ensure that your cloud platform operates reliably and accurately.
LAN/WAN Qualification: We provide validation services for LAN/WAN infrastructure to ensure that they meet regulatory requirements and operate reliably and accurately. Our testing and documentation activities include functional testing, performance testing, user acceptance testing, and validation documentation.
Network Component Qualification: We provide validation services for network components such as switches, routers, firewalls, and load balancers to ensure that they meet regulatory requirements and operate reliably and accurately. Our testing and documentation activities include functional testing, performance testing, user acceptance testing, and validation documentation.
Infra Tools Qualification: We provide validation services for infrastructure tools such as monitoring and backup software to ensure that they meet regulatory requirements and operate reliably and accurately. Our testing and documentation activities include functional testing, performance testing, user acceptance testing, and validation documentation.
We follow a rigorous quality assurance process to ensure that our services meet the highest standards of quality and compliance. Our team has extensive expertise in compliance and regulatory requirements and can provide guidance on how to maintain compliance with the relevant regulations.
If you are looking for comprehensive computer system validation services for your infrastructure components, we are here to help. Contact us today to learn more about our services and how we can help you validate your infrastructure components with confidence.
- Training Audit preparation
- 21 CFR Part 11
- GaMP 5
- GxP
- IT Audit
Our computer system validation services also include comprehensive training programs to ensure your team is equipped with the necessary knowledge and skills to maintain compliance with industry regulations. Our training services cover a range of topics, including: Training Audit Preparation: We offer customized training programs to prepare your team for upcoming regulatory audits, ensuring they are confident and fully prepared to demonstrate compliance.
21 CFR Part 11: Our experts provide training on the FDA's 21 CFR Part 11 regulations for electronic records and signatures, including the use of electronic systems in clinical trials and other GxP-regulated environments.
Good Automated Manufacturing Practice (GAMP) 5: We offer training on GAMP 5, which provides a framework for computer system validation in regulated industries. Our training covers GAMP 5 principles and guidelines for risk-based computer system validation.
Good Manufacturing Practice (GMP): Our training covers the FDA's GMP regulations, which set the standards for the production and testing of pharmaceuticals, medical devices, and other regulated products.
IT Audit: Our experts provide training on IT auditing, including best practices for auditing computer systems, reviewing documentation, and identifying areas of non-compliance.
At our company, we understand the importance of ongoing training and education to ensure compliance with regulatory requirements. Contact us to learn more about our training programs and how we can help your team stay up-to-date on the latest regulations and best practices.
- Compliance as per 21 CFR part 11
- Compliance as per IT Computer system requirement
- Audit preparation
We understand the importance of ensuring your computer systems are compliant with industry regulations and are prepared for regulatory audits. Our IT audit services cover a range of areas, including:
Compliance as per 21 CFR Part 11: Our experts provide auditing services to ensure your electronic records and signatures are compliant with the FDA's 21 CFR Part 11 regulations. We review your computer systems, software, and procedures to identify any areas of non-compliance and provide recommendations for corrective actions.
Compliance as per IT Computer System Requirements: Our IT audit services also cover compliance with other regulatory requirements for computer systems, including GAMP 5, EU Annex 11, and other industry standards. We review your computer systems and software to ensure they meet these requirements and provide recommendations for improvements where necessary.
Audit Preparation: We offer audit preparation services to ensure your team is fully prepared for upcoming regulatory audits. We review your documentation, procedures, and computer systems to identify any potential areas of non-compliance and provide recommendations for corrective actions.
At our company, we are committed to providing comprehensive IT audit services to help our clients maintain compliance with industry regulations and prepare for regulatory audits.
Contact us to learn more about our IT audit services and how we can help your organization ensure compliance with regulatory requirements.