Pharmatek Solutions Experts employ a risk-based approach to the validation process that is tailored to our clients’ priorities and needs. Our extensive experience in life sciences software and systems across the globe ensures that we are able to provide you with the support that you require.
Modern regulations outline requirements pertaining to computerized systems used in the creation, modification, maintenance, archival, retrieval, and transmission of data. Validation provides a high degree of assurance that both new and existing computer systems meet these requirements and deliver results based on your specifications and required quality attributes.
Contact us to discuss our services and develop a custom plan to support your Computer System requirements.
Computer System Validation – Accuracy and Consistency
Over the past decades, the life science industry has progressively introduced computer systems to support clinical trials, manufacturing, control, and logistics processes. Consequently, these computer systems have become critical elements for regulations on electronic data integrity.
Pharmatek Solutions employs experts with unique experience in computer systems management across the globe. We work with you to identify gaps in your computer system process and develop solutions that meet your needs. Our support includes regulatory compliance, electronic quality system management, and validation packages.
Build a system that will support your business through the entire development chain of your therapy with Pharmatek Solutions.
Our range of Validation services include:
- GAP Assessment
- System Risk and Regulatory Applicability Assessment
- User requirement specifications
- System Architecture Design
- Validation plan
- Functional requirement specifications
- Network and Infrastructure Qualification
- Installation Qualification (IQ) Scripts and Results
- Operational Qualification (OQ) Scripts and Results
- Performance Qualification (PQ) Scripts and Results
- Traceability Matrix development
- Validation Report
- System Release Documentation
- Hypercare Solutions