Life Sciences Consulting Services

Bytecubit Life Sciences Service Offerings

Computer Systems Validation (CSV) Value Proposition


IT Compliance is essential in the Life Science companies and cannot be neglected. What needs to be validated, How much validation is required, How to achieve Part 11 compliance are the ever changing debate going on in the Life Science Industries. The intent of any Validation exercise should confirm the suitability of the IT systems for its intended use, be compliant with regulatory expectations to assure data integrity, reliability and security of a system and should not be over engineered. Validation is not a once off event but it is an ongoing process. Identifying a suitable vendor who can support the on- going validation needs of their IT system, maintaining a long-term relationship, following a set of best practices are always the challenges in decision making. With its proven track of Ensuring compliance through validation of In-House developed systems as well as leading industry-standard and compliant COTS applications, Bytecubit CSV services fits into Life Sciences firms ongoing needs to streamline compliance operations for GxP systems, reduce multi-vendor service environment and essentially re-engage and focus on core business activities.


Offerings Computer system validation at Bytecubit is a risk based regulatory compliant service for the Life Sciences firms (Pharmaceuticals, Medical devices, Biopharmaceuticals and clinical Research Organizations) to validate the computerized systems used in the GxP Environment.

CSV services at Bytecubit is well matured and has the following offerings:

Validations: Risk based validation which follows the GAMP 5 framework for Prospective, Retrospective, and concurrent validations of computer systems, software tools and applications and On-Going Validation support.

Risk Assessments: Practical recommendations and advice on the implementation of 21 CFR Part 11 for GxP systems. Functional Risk assessments to identify the impact level of computer system which determines the extent of validation required.

Validation Documentation:
Bytecubit can support with compliant validation document templates spanning the end-to-end CSV activities which includes but not limited:

• User requirement specifications
• Functional Specification
• Design specification
• 21 CFR Part 11 Checklist
• Functional risk assessments
• Validation Plans
• Validation Protocols
• Installation Qualification
• Operational Qualification
• Performance Qualification
• Test case and Test Execution
• Post Execution Reviews
• Change Control


Bytecubit compliant Computer System Validation Services helps our clients in reaping the following benefits:
• Certified portfolio of GxP applications ready for Regulatory Audits
• Lean validation framework helped in reducing the validation cost Vs effort
• Access to global regulatory expertise which helped in harmonized compliance approach
• Our benchmarking shows 40% reduction in validation cost through cost effective best-shore [Onsite (local) – Offshore (remote)] engagement models with a typical 2:3ratio
• Higher cost reduction due to low onsite ratio
• Flexible staffing based on resource load variations

Service Offerings:
Bytecubit E2E validation services suits the differing needs of the customer
• End to End application Validation
• Infrastructure Qualification testing
• 21 CFR Part 11 assessments and remediation
• Validation Consulting Domain strength:
• Subject matter experts with exhaustive experience in executing CSV for Life Sciences
• Risk based Lean Validation framework in accordance with GAMP 5 approach. Unique risk assessment framework (GxP, 21 CFR Part 11, high level functional assessments etc.,) involving client quality team and system owners helps in addressing only critical functionality that has got high system impact.
• Optimum resource utilization keeping only critical activities at onsite. Validation Templates:
• Validation documentation.


Bytecubit Computer System Validation services help Life Sciences firms to simplify the complexities of compliant validation exercise.

• Subject Matter Expertise: Subject matter experts (SMEs) uniquely positioned to provide industry/domain knowledge and ensure client demands are being met.
• Engagement Models: The right mix of engagement models and the ability to ramp-up and ramp-down, based on need
• Validation Consultants: Industry experienced Validation consultants can be deployed to support client validation projects