Computer Systems Validation

In highly regulated industries such as pharmaceuticals, biotechnology, and medical devices, the reliability of computer systems directly impacts public health, patient safety, and regulatory compliance.

Computer Systems Validation (CSV) is the structured process of testing, validating, and formally documenting that a computer-based system consistently performs as intended. By ensuring systems are secure, reliable, and traceable, CSV establishes confidence that critical applications — from laboratory instruments to manufacturing platforms — meet stringent FDA, cGMP, and global compliance requirements.

At Envisage, we bring deep domain expertise in validating new systems, system upgrades, and legacy platforms — enabling companies to scale with confidence while meeting evolving regulatory standards.

Key Use Cases

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Alignment to FDA Compliance &
Regulatory Standards

Ensuring systems meet 21 CFR Part 11, cGMP, and other FDA/EMA requirements, backed by rigorous documentation and audit readiness.

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Implementing New Systems


Validating newly deployed lab instruments, manufacturing systems, and enterprise platforms to guarantee accuracy, performance, and reliability.

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Upgrades &
Changes to Existing Systems

Supporting system enhancements, software upgrades, and configuration changes, ensuring they meet validation protocols without disrupting operations.

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Ensuring Performance &
Reliability


Verifying system performance through testing, qualification, and monitoring to minimize downtime and ensure business continuity.

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Fortifying Security &
Patient Safety


Validating systems for data integrity, traceability, and security controls, safeguarding both patients and sensitive clinical/manufacturing data.

Solutions Delivered

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CSV Support for Pharmaceutical Firm

Supported a Boston-area pharmaceutical firm with CSV (21 CFR Part 11) validation across newly implemented PCs and software platforms. This validation effort allowed the company to scale operations and double team size following an influx of investment capital.

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QMS Validation for Biotech Firm

Collaborated with a Boston-based biotech company to assess QMS performance and risk. We carried out end-to-end testing, validation, and documentation, ensuring the company’s systems consistently met quality and regulatory expectations.

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Equipment Qualification for Global Pharma

Partnered with a global pharmaceutical firm focused on Cell & Gene Therapy to perform qualification and validation of manufacturing equipment, analytical lab tools, benchtop devices, and facilities. Our work ensured compliance with cGMP practices, supporting both regulatory submissions and audit readiness.

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End-to-End Validation Services

Provided specialized staffing and consulting support for validation engineers, QA specialists, and CSV experts, helping clients meet project deadlines and maintain compliance during regulatory inspections.

Next Steps to Kickstart Your Project Today

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Explore Your Idea

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Receive Your Proposal

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Launch the Project

With the agreement in place, we assemble a multi-disciplinary team to initiate and drive your project forward.

FAQs

What is Computer Systems Validation (CSV)?
CSV is the process of verifying that a computer-based system performs exactly as intended, in a consistent, secure, and traceable manner, ensuring compliance with FDA and industry regulations.
Why is CSV important in pharmaceuticals and biotech?
Because computer systems directly impact product quality, patient safety, and regulatory compliance, validated systems are essential to avoid compliance risks and ensure business continuity.
Does Envisage provide support for FDA 21 CFR Part 11 compliance?
Yes. We have extensive experience validating systems under 21 CFR Part 11, ensuring data integrity, audit trails, and compliance with FDA/EMA expectations.
Can Envisage help with both new systems and upgrades?
Absolutely. We validate new implementations, upgrades, configuration changes, and legacy platforms, ensuring they meet required performance and compliance standards.
Do you also provide staffing for CSV projects?
Yes. We provide highly skilled CSV engineers, validation specialists, and QA professionals who integrate seamlessly into client teams, ensuring timely delivery and compliance.