What are Equipment Procurement Services?
Our services encompass strategic sourcing, vendor qualification audits, FAT/SAT coordination, and installation oversight, ensuring pharmaceutical equipment meets GMP standards and operational requirements.
Equipment Procurement for Pharma Compliance
Streamline Sourcing with Expert Vendor and Installation Support
At Indivirtus Healthcare Services Pvt. Ltd., our Equipment Procurement services provide end-to-end support for pharmaceutical and biotech facilities. From vendor audits to FAT/SAT coordination and installation, we ensure regulatory compliance, timely delivery, and cost-efficiency for your equipment sourcing needs.
Why is it Critical?
Compliant equipment procurement ensures product quality, regulatory adherence, and operational efficiency, minimizing risks and supporting seamless integration into pharmaceutical facilities.
Our Role in Your Success
As a trusted CRO, Indivirtus Healthcare Services delivers expert-led procurement solutions, streamlining sourcing from global or local vendors to achieve regulatory compliance and cost-effective outcomes.
Our Expert Procurement Approach
At Indivirtus Healthcare Services, our Equipment Procurement services are led by experienced consultants with global regulatory expertise. We identify qualified vendors, conduct thorough technical audits, coordinate Factory Acceptance Tests (FAT) and Site Acceptance Tests (SAT), and oversee equipment installation and hook-up to ensure compliance with GMP standards.
Our tailored approach integrates strategic sourcing plans with rigorous quality checks, delivering compliant and efficient solutions that align with your facility’s operational and regulatory needs, ensuring timely and cost-effective project execution.
Equipment Procurement Deliverables
Approved Equipment List (AEL): Curated list of compliant equipment for your facility.
Vendor Qualification Reports: Detailed audits ensuring vendor reliability and compliance.
FAT/SAT Coordination Reports: Comprehensive documentation of acceptance testing.
Sourcing Plan (Global/Local): Strategic roadmap for cost-effective procurement.
Installation & Hook-Up Report: Detailed records of equipment integration and commissioning.
Regulatory Compliance & Global Standards
Our Equipment Procurement services align with stringent global standards, ensuring your equipment meets regulatory requirements and is audit-ready. By adhering to industry-leading guidelines, we deliver solutions that enhance compliance and operational confidence for international markets.
- USFDA 21 CFR Part 11: U.S. regulations for electronic records and equipment compliance.
- EU GMP Annex 11: European guidelines for computerized systems in GMP environments.
- WHO TRS 1019 Annex 2: Global GMP guidelines for facility and equipment design.
- ICH Q7: Good manufacturing practice guide for active pharmaceutical ingredients.
- ISPE GAMP 5: Guidelines for automated systems validation and compliance.
Applications & Use Cases
Our Equipment Procurement services are essential for pharmaceutical and biotech facilities sourcing equipment for new setups or upgrades. Ideal for ensuring GMP compliance, our solutions support vendor selection, equipment qualification, and installation for regulatory audits. Key use cases include procuring manufacturing equipment, integrating automated systems, and ensuring compliance for global market expansion.
Why Choose Indivirtus Healthcare
Indivirtus Healthcare Services is a trusted partner for pharmaceutical and biotech manufacturers, delivering expert-led procurement solutions backed by certified consultants with global regulatory experience. Our services ensure scientifically defensible outcomes, rapid delivery, and strict confidentiality to protect your proprietary information.
With a commitment to industry best practices, we streamline your procurement process to achieve regulatory success and operational excellence, ensuring compliant and cost-effective equipment integration.
Frequently Asked Questions
Frequently Asked Questions
What is covered under vendor selection and audit for pharma equipment?
We evaluate vendors based on regulatory history, quality systems, financial stability, and technical capabilities. Site audits ensure the equipment meets cGMP and user requirements.
What are FAT and SAT in equipment procurement?
FAT (Factory Acceptance Test) ensures equipment performs as per specs before dispatch, while SAT (Site Acceptance Test) validates it post-installation. We manage both processes end-to-end.
Can you support both international and local equipment sourcing?
Yes, we leverage a vetted network of global OEMs and regional suppliers to source high-quality equipment aligned with project specifications and budget goals.
Do you assist with installation and utility hook-up of procured equipment?
Absolutely. We coordinate installation, calibration, utility connections, and alignment with cleanroom layouts or containment designs, ensuring readiness for qualification.
How long does the equipment procurement process typically take?
The timeline varies based on equipment complexity and sourcing region, but typical procurement cycles span 6–10 weeks including testing and installation.
What do Equipment Procurement services include?
Our services include strategic sourcing, vendor qualification audits, FAT/SAT coordination, installation oversight, and hook-up support, ensuring GMP-compliant equipment for pharmaceutical facilities.
Who benefits from Equipment Procurement services?
Pharmaceutical and biotech manufacturers sourcing equipment for new facilities or upgrades, particularly those requiring GMP-compliant solutions, benefit from our tailored procurement services.
How do these services ensure regulatory compliance?
Our services align with USFDA 21 CFR Part 11, EU GMP Annex 11, WHO TRS 1019 Annex 2, ICH Q7, and ISPE GAMP 5, ensuring equipment meets global regulatory standards and is audit-ready.
What deliverables are provided with the service?
Clients receive an Approved Equipment List (AEL), vendor qualification reports, FAT/SAT coordination reports, a sourcing plan (global/local), and an installation & hook-up report.
Can the procurement services be customized for our facility’s needs?
Yes, our services are tailored to your facility’s specific operational and regulatory requirements, ensuring compliant and efficient equipment sourcing and integration.
How do the services support FAT/SAT and installation coordination?
We coordinate Factory and Site Acceptance Tests (FAT/SAT) and oversee equipment installation and hook-up, providing detailed reports to ensure compliance and operational readiness.