Life Sciences

Portford Solutions is an expert in the Software Development Life Cycle (SDLC) process. Proficiencies include broad Computer System Validation (CSV) experience: Information Systems (IS) Interactive Voice Response (IVR) and Interactive Web Response (IWR) Electronic Case Report Forms (eCRF) Handheld and IVR based efficacy data collection (eDiary) Standardized, scalable, and reusable SDLC based CSV Custom systems, including those that are SAS and UNIX based Appropriate Regulatory Impact Assessment The life science team has successfully validated a broad range of custom and vendor based software systems.   Project Management Providing exemplary project management and project oversight services is the hallmark of Portford’s engagements. This includes scheduling, deliverable management and production, and coordination of deliverable Review and Approval cycles. Portford Solutions consultants are adept at working with matrixed team members to get the job done accurately.   Vendor Assessment Ensuring vendor compliance is a necessary part of large integration projects. Portford consultants will leverage their CSV, GxP, and 21 CFR Part 11 knowledge to verify that vendors’ internal procedures reflect industry best practice. Assessment functions include: drafting gap analyses, collaborating with underperforming vendors, developing appropriate mitigation plans, and implementing remediation solutions. Further, Portford can audit, assess, and validate vendor based CSV systems.   Document Management Portford Solutions is a Documentum partner, with years of experience deploying enterprise level document management systems. Also available are in-house and client-side imaging solutions to create true end-to-end document management products. These compliant document conversion services are available on-site or at Portford’s state-of-the art production facility.