Today’s life sciences companies are faced with a myriad of regulations driving increasing reliance on advanced enterprise solutions to achieve sustained compliance and efficiency. In most cases, automated systems that drive mission-critical cGMP and manufacturing processes require software validation. Validation ensures that systems perform according to their intended use and are in compliance with key regulatory requirements such as 21 CFR Part 11, and other mandates.
TechPIT Solutions offers an experienced, practical risk-based approach to validating enterprise computer systems. Our validation methodologies are in compliance with GAMP 5, ASTEM E2500-07, FDA, EMEA and other key guidance’s. We offer validation services for Commercially-Off-The-Shelf (COTS) and custom (bespoke) software applications.
KEY VALIDATION DELIVERABLES
As part of our expert validation services, we help you produce key validation deliverables such as:
- Validation Master Plan
- User Requirements Specifications (URS)
- Functional Requirements Specifications (FRS)
- Software Requirements Specifications (SRS)
- 21 CFR Part 11 Gap Analysis
- Supplier Audit
- Validation Risk Assessment
- Specification Trace Document
- Disaster Recovery Plan
- Software Migration Plan (For Legacy Systems)
- Installation Qualification (IQ) Test Protocols
- Operational Qualifications (OQ) Test Protocols
- Performance Qualifications (PQ) Test Protocols
- Validation Standard Operating Procedures (SOP)
- Validation Certification Document
Each validation effort is unique and may require additional documentation beyond those listed above to ensure compliance. We can help you effectively plan and maintain the validated state. Contact us for details.