Business and GxP compliant solutions, services by SarjenBusiness and GxP compliant solutions, services by SarjenBusiness and GxP compliant solutions, services by Sarjen

Computer Software Validations

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

Sarjen strengths

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
Dedicated implementation team for responding to client queries and support

Software validation and Data integrity services:

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 audits Efficient 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

Help review

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
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