Per 21 CFR part 11 and Annex 11 compliance, and suggested by GAMP 5, a risk based software validation (computer system validation, CSV) is a mandate. A secure environment must be maintained and CSV for electronic signatures and electronic records be maintained to ensure data integrity. Sarjen offers Software validation services to ensure a validated software environment for regulatory complicate.
Challenges in regulatory requirements, stringent regulations are forcing companies, especially pharmaceutical, life sciences companies, CROs, etc. to have an approach which aligns with the regulatory requirements, company strategies.
Even mega conglomerates are fined heavily for non-compliance which makes other companies jittery to ensure regulatory compliance, lest they fail regulatory inspection and audit.
Sarjen understands the regulatory requirements, makes understand the benefits of integrated compliance approach, rigorous and thorough training of software implementation.
Sarjen possesses rich exposure to various GxP standards as well as regulatory guidelines such as ANNEX 11 for computer systems, 21 CFR part 11, GAMP 5. Sarjen is also an ISO 9001:2015 (where ISO 9001 is internationally recognized as the gold standard for quality management systems) certified software development company.
Understanding the vital aspects of software validations, Sarjen provides validation consulting services based on these validation models by creating a systematic approach:
- Software development validation consulting services
- Software implementation validation consulting services
- 21 CFR part 11 and Annex 11 compliance
- Cloud based validation
- Over 10 years of experience in the area of computer system validation, CSV & regulatory compliance consulting services
- Trained & highly experienced team for validation consulting & validation
- Executed thousands of validation protocols
- Experience of having worked with major pharmaceutical companies, CROs in India and abroad as well as assisting for various audits related to the computer system validation, CSV
- Efficient team of Subject matter experts, Regulatory consultants, Software validation experts, QA, to support a team of on-site validation
Guide and Support
- Related to quality compliance oversight to all aspects of CSV, CSV project management
- In preparing, executing, and finalizing the validation of computerized systems
- In document validation activities, change controls, validation protocols, reports, etc.
- In CSV regulatory auditsEfficient team of Subject matter experts, Regulatory consultants, Software validation experts, QA, to support a team of on-site validation
- In Data governance, management to avoid Data Integrity
- To project teams for project deliverables
- In preparation and mandatory review of departmental SOPs (related to CSV), also give required training to the users
- In managing mandatory and periodic trainings
- Document validation activities, change controls, validation protocols, reports, etc.
- Validation deliverables
- Design Qualification + Vendor management, Change controls, validation protocols, reports, etc.
- Setting up and maintaining IT solutions and services under regulatory requirements
On the basis of
- Extensive experience is SDLC and Computer System Validations (CSV)
- Extensive knowledge of the US FDA 21 CFR Part 11, EU Annex 11 regulations and guidelines for electronic records and electronic signatures
- Knowledge in Quality Risk Management
- Handling of product: categories 3 (Commercial-Off-The-Shelf (COTS)), 4 and 5 from specification to verification under GAMP 5 – Design Specification (DS), Installation/Operation/Performance Qualification (IQ, OQ, PQ), Change Control, Impact assessment, of computerized systems
- Experience with Testing – end-to-end, acceptance, regression, functional, testing
- Vast experience in Pharma and Life science domains
- Experience in Software validation and compliance activities in Pharma (GMP) environment
- Hands on experience in working with GxP applications
- Experience in creation/maintenance & implementation of SOPs