Validation Services
Responding to a FDA warning or 483 letter?
Preparing for an audit?
Implementing new systems (software, equipment, LIMS system)?
There is an ongoing business challenge of getting new products to market safely. Given the complexity of multi-site, global clinical trials, postponing the upgrade of software applications is not surprising. At the same time, however, the additional functionality and performance improvements help you expedite reporting and data analysis across functional areas.
Compounding this quandary is the shortage of specialized in-house personnel who embody three disciplines necessary to the timely execution of software upgrades: technology expertise, domain expertise to understand the needs of all end-users and knowledge of current FDA guidelines.
Eliassen Group provides validation services to many of the nation's premier pharmaceutical, biotechnology and medical device companies. Based on client need, we offer contract staffing and project based services.
Our services include:
- 21 CFR Part 11 and/or Part 820 Assessment and Remediation
- Quality Assurance/Validation Plans
- Functional Requirements Specifications
- Detailed Design Specifications
- Installation Qualifications
- Operational Qualifications
- Performance Qualifications
- Process Qualifications
- Summary Reports
- SOPs, Guidelines
- Testing Execution
- Audits
Eliassen Group has provided validation services for:
- 21 CFR Part 11 Audits, Assessments, Remediation, SOPs and Training
- Laboratory systems including ovens, laboratory information systems (LIMS), chromatography data collection systems and instrumentation
- Other instruments including UV-Vis spectrometers, FT-IR spectrometers, high performance liquid chromatography (HPLCs), gas chromatographs (GCs), and capillary electrophoresis systems (CEs).
For more information on Eliassen Group Validation services, please email us at solutions@eliassen.com.