Computer System Validation and Computer System Assurance
Software validation is an integral part of an organizations basically to validate their products as per the regulations such as 21 CFR Part 11 Software Validation, 21 CFR 820 Software Validation, and GAMP 5 Computer System Validation. Organizations sometimes, face difficulties in building a software to complete the entire validation lifecycle.
Revive establishes documental evidence to support organizations to perform Software Verification and Validation, Computer System Validation (CSV), Pharma Software Validation, Pharma Computer System Validation, and periodical Process and Product Validation. We work hand-in-hand with clients from a concept to software to ensure clients’ products meet necessary Regulatory requirements.
REVIVE’s validation capabilities include:
- Computer System Validation
- Retro Validation
- GxP Business Continuity
REVIVE Motto
Computer System Validation (CSV)
Validation is an integral part, a challenging task for Pharma manufacturers that is required to assess whether the software product is in line with cGMP requirements or not. With the technological advancement of the Pharma industry and with more of online and virtualized processes, the potential risk of non-compliance is also on the rise.
Revive has expertise in modified waterfall or sprint methodologies performing progressive Computer System Validation (CSV) as per USFDA, EU, PIC/s, GAMP 5, ICH, WHO, 21 CFR Part 11 and EU Annex 11 ensures total Compliance and Validation at any stage during deployment, maintenance, and decommission.
- Progressive Software Validation as per Health Authority Guidelines
- GMP Software Validation Verification
- Compliance Software Solutions
- Software Regulatory Compliance
- Process Validation in Pharma
- Process Validation in Manufacturing of Biopharmaceuticals
- Computer System Validation in Pharmaceutical Industry
- Vendor Audit Services
- Accurate Methodologies
- Pre-designated Quality Gates to Minimize Re-works
- Validation Throughout the Lifecycle
- Validation Certificate
- Data Security and Compliance
Data Security and Compliance
Retro Validation
An expert GAMP 5 Software Validation partner to retrospect the systems, which are already defined and in the run for your organization at the time of Regulatory or customer audit.
Revive with an experienced compliance and validation team performs retrospective validation and makes your existing system compliant with GAMP Computer System Validation and ready to face any audit. We also perform Disaster Risk Assessment, Medical Software Verification, and Software Audit Services.
Our validation services encompass the following activities:
- Retrospective Validation for Existing Systems
- Analyzing Gaps in Existing Documentation
- Expert Validation Support to Fill the Gaps
- Validation Certificate
GxP and 21 CFR Part 11, EU Annex 11 (Electronic Record/Electronic Signature) Assessment:
Revive, with a dedicated team for validation, performs GxP and ERES assessments for existing systems and suggests practicable remediation. Right from assessment to suggesting better solutions to fill up the gaps to certifying the systems with GxP business continuity and disaster recovery adequacy on par with Regulatory guidelines. Revive offers end-to-end validation support for customers that includes:
- GxP Assessment, ERES (Electronic Record/Electronic Signature) Assessment
- CSV (Computer System Validation), Audit Trail Adequacy Assessment
- FDA Software Validation Services
- BCM (Business Continuity Management) & DR (Disaster Recovery) Adequacy Assessment
- Vendor Audit Services – Vendor Audit and Qualification Assessment
- Manufacturing Facility Audit Services
REVIVE Advantages
- Experienced and practicing professionals ensuring product quality, Regulatory compliance, patient safety, data integrity and security
- Integrated process models
- Effective and compliant business processes
- Proven qualification strategies and validation services for life sciences industries
- Significant cost savings