Process Stream’s Information Technology Quality & Compliance (IT Quality) team specializes in the full Software Development Life Cycle (SDLC) for electronic quality management systems used in the regulated industries. We support and provide expertise for systems that track various quality indicators in the Life Sciences and Medical Devices industries.
Whether your organization is implementing a new electronic quality management system, performing upgrades to its existing system, switching from paper to electronic, or on premises to cloud architecture, our team has the proven knowledge, skills, and experience to navigate you to your IT Quality goals.
We take pride in our ability to assess our clients’ business processes and align with applicable regulatory requirements to determine the impact and required internal IT controls, qualification and testing approach. Our IT Quality practice primarily focuses on the following information technology quality elements:
- Software Validation. We work closely with life science organizations to help achieve its compliance goals by authoring, reviewing, and executing validation documentation tailored to fit current processes. Enhance your existing validation practice with a team of experienced validation SMEs, or upgrade to our proven validation methodology.
- Remediation. We review and update your existing documentation to reflect the current validated state, and if required, will overhaul your IT Quality process to maximize the efficacy of your Quality Management System.
- Risk Assessment. We assess any and all risks pertaining directly to your business process to determine your compliance needs, and maintain compliance with FDA 21 CFR Part 11, Electronic Records and Electronic Signatures and EudraLex Annex 11: Computerized Systems regulatory requirements.
- Training. We provide technical SMEs to deliver classroom instructor-led training to all levels within your organization, as well as professional technical writers to author training materials specific to your business. We identify the extent of training required to meet IT Quality, then create and implement customized training programs specific to your needs.
- Quality Programs. Our IT Quality team customizes and implements quality programs to mitigate risk and reduce costs within your organization. We have extensive experience working with Life Sciences and Medical Device organizations in particular. Whether you are looking to streamline your software testing approach using a risk-based methodology, improving training effectiveness, or managing computerized system changes, our team can help you achieve your quality programs goals.
- Quality Review and Support. In addition to our Quality Programs, we provide on-site or off-site expertise to give clients a unique perspective on Software Quality Assurance and provide innovative solutions to IT Quality & Compliance needs in the Life Science industry.
- Data Integrity Assessment (DIA). Whether your system is paper or electronic, our DIA team will conduct the Data Integrity gap assessment to identify vulnerable areas or processes and work with your internal team to develop an achievable data integrity remediation plan.