Valina Services - a truly E2E CSV services provider

How can we help you today?

A problem is a solution in disguise and a challenge to us at Valina to learn, study, dissect and suggest a sustainable roadmap to you.

We just don't work with you, but partner with you for delivering solutions, which would positively impact your organization and help save lives.

Your partner in transitioning to CSA

Have you started thinking about your strategy to transition to CSA? Does it sound complicated to you? Have you figured out the challenges of the implementation?

Whether you have thought or thinking about it, we are here to make your journey hassle-free without missing a step in the process, all the while making you ready for the regulatory audit.

Our experts at Valina, understand the ramifications of the transition and is ready with a blueprint to help you. CSA would be the future gold standard and an early strategy to embark this journey would be critical to your business and compliance success.

Write to us to know how we can take this journey together, which would effectively bring down your validation efforts by more than 30% and reduce paperwork by 80%.

Our Consulting Services and Solutions

We at Valina, help you to build strategy, provide consulting, audits, training, and process improvement services within the industry-standard Compliance framework.

Computerized System Validation

Let us help you to validate your IT GxP systems in Drug Discovery, Clinical, Manufacturing, and Drug Safety based on industry best practices.

CSV Maintenance Services

Periodic & Access Roster Review, Change Management, Documentation review are some of the CSV maintenance services to ensure that your IT systems are compliant.

21 CFR Part 11 Assessment and Gap Remediation

Are your IT systems Part 11 compliant, when was the last time you did a Part 11 assessment check.

Valina's checklist would help you to conduct an as-is Part 11 compliance assessment and define a roadmap for you to be audit-ready.

Audit Readiness and Inspection Management

Whether it's an upcoming regulatory audit, inspection, internal quality audit; we can help you to prepare with our checklist and determine the audit-readiness of your GxP IT systems.

Validation Remediation

Do you need to investigate, strategize for resolution and action your Audit action items. Or, due to a Periodic Review, Change Management - your validation package needs an overhaul.

We would be happy to partner with you to remediate and close the action items successfully.

Quality Management System

With decades of experience in validating GxP IT systems on established and industry-best Quality Management Systems (QMS) methodologies, we know the best-fit QMS for your company based on GxP IT systems and their business criticality, resources, and exposure to regulatory authorities.

SOP Development and Maintenance

SOP Development, Review, Archiving are the services that we provide to keep your QMS framework relevant.

If you have recently taken over or merged with another entity, we can harmonize your SOPs and make it streamlined, centralized and accessible.

Manufacturing IT Validation

Our expertise in SCADA, MES, ERP and legacy Manufacturing IT systems would help you maintain validated systems and ensure Data integrity across the applications.

Our Periodic Review and maintenance services, would help you mitigate any impending risks.

Data Integrity assessment

Whether you have DI open action items, or want to conduct a DI assessment of your Laboratory IT or Manufacturing IT systems - our experts can conduct an extensive consultative approach towards Data Integrity assessment.

Valina Services - Smart and just the right-sized validation for you

Valina Services is a pure-play validation and qualification services provider for IT GxP ystems used in regulated environmentsin Drug Safety, Manufacturing, Clinical Development & Management and RnD.

Headquartered in Singapore and serving clients globally, we respond to the needs of Pharmaceutical, Biotech, Medical Devices, Cosmetics, Food and the additives sector to meet their regulatory challenges in managing the qualification of their IT systems, Equipment and instruments used for manufacturing their products, medicines, drugs, food and cosmetics.

What Our Partners Have to Say About Us

We believe that our best spokespersons are our clients, who have partnered with us in their short to long-term journey towards achieving the goals they had. Keep checking out this space here.

Tell us, how can we help you?

We would be deligted to address you, if you can let us know a little bit about you and your requirement.

Valina Services

SINGAPORE (048616)

Validation services

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