Quality and Compliance
SMS offers validation and regulatory consulting services. Combining the GAMP life-cycle validation methodology with strong internal procedures, our team delivers flexible and diverse validation packages. SMS has developed a process and a suite of services designed to ensure that our clients are in compliance with the applicable sections of the cGxP and 21 CFR Part 11. The process will assure the quality of the computerized system through the development and/or execution of requirements, specifications, design, coding, testing, installation, and acceptance.
Expert Validation Consultants
SMS’ validation team comprises professionals who are highly experienced in both regulatory compliance and information technology. Our team possesses a deep understanding of the latest technological advancements and regulatory requirements, enabling us to provide effective validation services to our clients.
Customized Validation Solutions
At SMS, we understand that every client has unique validation needs. Our team of validation experts works closely with each client to develop customized validation plans and procedures that are tailored to their specific requirements and objectives.
Compliance Assurance
SMS' validation team ensures that our clients' computerized systems comply with all applicable regulatory requirements, including cGxP and 21 CFR Part 11. Our team conducts thorough audits, develops robust policies and procedures, and executes comprehensive validation plans to guarantee the quality and compliance of computerized systems.
SMS’ validation group consists of individuals with experience in both regulatory compliance and information technology. SMS consultants are keenly aware of the ever changing technological and regulatory challenges our clients are faced with allowing us to deliver high impact professional services to our clients.
SMS Validation
Benefits
Compliance with cGxP and 21 CFR Part 11
Customized validation plans and policies
IT system and software validation
Improved quality and compliance regulation
Contact Us To Learn More About Quality and Compliance
Capabilities
Audits & Remediation
Plans
Our team conducts thorough audits and remediation plans for clients to identify gaps and ensure compliance with industry regulations. We work with clients to develop and implement corrective action plans that address any deficiencies in their quality management systems.
Client Validation Life Cycle Audits
We offer client validation life cycle audits that ensure compliance with regulatory requirements throughout the entire software development process. Our team evaluates each stage of the development process, from requirements gathering to post-market surveillance, to ensure that clients meet all regulatory requirements.
Policies & Procedures
We provide policies and procedures development services that are tailored to meet the specific needs of each client. Our team helps clients establish robust quality management systems by developing and implementing policies and procedures that comply with industry standards and regulatory requirements.
Software Validation
We offer comprehensive software validation services that ensure compliance with FDA regulations, including 21 CFR Part 11. Our team follows the GAMP life-cycle validation methodology to deliver flexible and diverse validation packages, including condition-based maintenance and predictive maintenance. We evaluate software systems throughout their development life cycle, from requirements gathering to post-market surveillance, to ensure regulatory compliance.
Validation Plans
SMS provides comprehensive validation plans that document the testing and qualification processes for computerized systems. These plans outline the necessary protocols and testing criteria, ensuring that your system is compliant with regulatory requirements.
Disaster Recovery Plans
In the event of an unexpected system outage or data loss, SMS can help you develop and implement a disaster recovery plan to minimize downtime and protect critical data. Our team can work with you to identify key recovery objectives, develop a disaster recovery plan, and test the plan to ensure it is effective.
Operation & Security Procedures
Our team can develop and implement comprehensive operation and security procedures to ensure that your computerized systems are operated securely, and in accordance with regulatory requirements. These procedures help to prevent unauthorized access to data and ensure the integrity of your systems.
User Requirements &
Design Documents
Our team can assist you with the development of user requirements and design documents for computerized systems. These documents provide a detailed overview of the system's functionality and are used to ensure that the system meets user needs.
Protocols, Test Plans
& Test Scripts
SMS can develop and execute protocols, test plans, and test scripts to validate the functionality of your computerized systems. These documents outline the testing criteria and procedures that will be used to evaluate the system's performance and ensure compliance with regulatory requirements.
Change Management & Control
SMS provides change management and control services to ensure that changes to computerized systems are properly documented, evaluated, and approved prior to implementation. Our team can help you develop a change control process that ensures that changes are made in a controlled and compliant manner.