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QUALIFICATION & VALIDATION / PROTOCOLS TO EVIDENCE
Equipment Validation & Qualification Services
Qualify your equipment with defined tests and documented results.
SOLVE provides equipment qualification services, validation protocol development, and onsite execution for laboratory equipment, manufacturing equipment, and utilities. We develop the protocols, perform approved tests, document deviations, and prepare the final report for your site’s review.
Validate & Qualify
ISO 8573 · Purity · Sampling
Flexible project support
Protocol writing, execution or project completion
Traceable evidence
Requirements linked to tests and actual results
Clear review status
Outcomes, deviations and remaining actions
01/ Validation scope
04/ Deliverables
05/ Pricing & Quote
06/ FAQs
01 Study scope
What can we validate or qualify?
Equipment validation services begin with intended use and approved requirements. Our scope covers laboratory, utility and process equipment. The examples below guide project planning; equipment boundaries, qualification stages and acceptance criteria are defined in your approved protocol.
Laboratory equipment qualification and manufacturing equipment qualification begin with intended use and approved requirements. The quotation identifies qualification stages, protocol preparation, onsite validation services and validation report preparation included.
01/ EQUIPMENT OR SYSTEM
Laboratory equipment
Establish documented readiness for washers, incubators, ovens, balances and centrifuges. Our laboratory equipment qualification links intended use to approved IQ, OQ and PQ checks, covering installation, operating functions and defined performance.
03/ EQUIPMENT OR SYSTEM
Cooling equipment
For process chillers, recirculating temperature-control units and heat exchangers, we develop and execute checks for controls, alarms and temperature response under defined loads. Process chiller qualification documents performance against approved acceptance criteria.
02/ EQUIPMENT OR SYSTEM
Process equipment validation
Mixers, blenders, mixing and holding vessels, homogenizers and transfer pumps. Verify equipment installation, speed or flow controls, interlocks and performance under specified operating conditions.
04/ EQUIPMENT OR SYSTEM
USP water systems
Define qualification boundaries for USP Purified Water and Water for Injection (WFI) systems, including generation equipment, storage tanks, pumps and distribution loops. Utility qualification services cover approved installation and operational checks, with performance testing and sampling responsibilities established in the protocol.
05/ EQUIPMENT OR SYSTEM
Equipment changes: define what needs retesting
After a move, modification or upgrade, identify which functions and qualification records are affected. Our equipment requalification services use the change assessment and existing evidence to define targeted tests, document results and prepare the report for site review.
IQ OQ PQ services matched to intended use
IQ — Installation Qualification: Verify installation, connections, components, instruments, and supporting records against approved requirements.
OQ — Operational Qualification: Test functions, controls, alarms, and interlocks across the approved operating range.
PQ — Equipment Performance Qualification: Verify equipment performance under defined conditions of intended use. User requirements and design review support can also be included.
02 A CLEAR BASIS FOR REVIEW
Why verify performance before release?
Your reviewers need to see how each requirement was tested and what the evidence shows. We link approved requirements to test records and report any gaps that affect the qualification conclusion.
Verify installation and operating functions against approved requirements.
Identify missing records, failed tests, and unresolved issues.
Check performance under the conditions defined in your protocol.
Give your reviewers a clear basis for approval and release decisions.
When do you need validation support?
Installing new equipment
Plan qualification before the startup deadline so prerequisites, testing, and review time are included.
Changing or relocating equipment
Assess what changed and which tests need repeating. Requalification is based on impact, not simply a repeat of every original test.
Closing documentation gaps
Review incomplete protocols, missing evidence, or unresolved deviations and define the work needed to address them.
Installing or modifying equipment
Define equipment boundaries, intended use, affected functions and qualification tests before installation or modification.
Before onsite execution
Agree on readiness before scheduling tests so the approved work can proceed.
Approved protocols, intended use and acceptance criteria.
Equipment access, utilities and calibration records.
Applicable procedures, vendor records and existing evidence.
Test materials, operator support and agreed test windows.
Site reviewers and an agreed deviation approval process.
02 THE RIGHT OUTLET - THE RIGHT TIME
Why test at the point of use?
Air quality can change as air passes through treatment equipment and distribution piping. Point-of-use compressed air testing checks the air at the outlets used by your process.
Check whether sampled outlets meet your air quality requirements.
Identify any tested outlets that need investigation.
Evaluate air quality after corrective action.
Maintain results and sampling records for quality reviews and audits.
When do you need compressed air testing?
Establishing a baseline
Understand air quality at selected outlets before setting up a routine testing program.
Planning periodic testing
Arrange recurring tests at intervals defined by your site’s risks, previous results, and requirements.
Installing or changing a system
Assess testing needs after installation, modification, or maintenance that could affect air quality.
Investigating an unexpected result
Check affected outlets and plan retesting after corrective action.
03 FROM REQUIREMENTS TO REVIEW
How SOLVE performs the work?
01
Define the project
Our GMP validation consulting starts with intended use, system boundaries, available evidence, and the decision due. We define the tests, responsibilities, and acceptance criteria for site approval.
02
Prepare the protocols
We write or adapt protocols using your templates and suitable vendor records. We link tests to requirements and confirm calibration, procedures, utilities, materials, and access before execution.
03
Execute onsite
Validation protocol execution follows the approved instructions. We record actual results, instrument references, and supporting evidence as each test is performed.
04
Address deviations
We document the deviation, assess its impact with your team, and propose a resolution. Corrective work and retesting follow your site’s approval process.
05
Report the outcome
We prepare the report with test outcomes, deviation status, and remaining actions. Your authorized reviewers approve the documents and decide readiness for use.
SOLVE
SOLVE
Prepare & Execute
Develop agreed protocols, execute approved tests, preserve actual results and prepare the qualification report.
STUDY SETUP
JOINT REVIEW
Assess & resolve
Review deviations and their impact together. Corrective work and retesting follow the site’s approval process.
YOUR SITE
YOUR SITE
Approve & release
Provide prerequisites, approve protocols and changes, and authorize readiness for use through your quality system.
Commissioning records and qualification
We review available vendor and completed commissioning records against the equipment’s intended use and approved requirements. Suitable evidence can support equipment qualification; gaps determine the additional qualification tests and records required.
04 DOCUMENTED OUTCOMES
What you recieve?
Engage us for a complete qualification project, protocol preparation, execution of approved protocols, or completion of unfinished work. Receive a clear record of what passed, what failed, and what remains open.
Your quotation confirms the documents and execution work included:
Qualification protocols prepared for site approval, with tests linked to requirements.
Executed protocols and test evidence, including actual results and references.
Deviation and retest records showing resolutions and outstanding actions.
A qualification report stating conclusions, limits, and unresolved items.
A findings review to support your site’s approval process.
Your quotation specifies document formats, review rounds, execution visits, and reporting. Protocol approval, change control, and final release remain with your site. Added tests, engineering work, or visits are assessed and quoted before proceeding.
FROM PROCESS STEP TO FOLLOW-UP
FOR DEMONSTRATION PURPOSE ONLY
How your findings can be organized
Traceable test records
Connect requirements, approved instructions, instrument references and actual results.
Visible open items
Identify deviations, retests and unresolved actions that affect the qualification conclusion.
This example shows structure only. It contains no actual test results, compliance conclusions or release decisions. The approved protocol and quotation define your project.
YOUR APPLICATION
Validation for your operation
Pharmaceuticals and biotechnology
Our pharmaceutical validation services focus on pharmaceutical equipment qualification and utility qualification within your quality system. Laboratory, utility and process equipment are assessed against their intended use and approved requirements.
Laboratories
Qualify equipment for its intended laboratory use, with tests matched to the functions and performance your team relies on.
Other manufacturing facilities
For food, beverage, nutraceutical, or cosmetic projects, share the equipment, product requirements, and reason for qualification. We confirm the technical fit and applicable work before quoting.
Equipment qualification services in California
Need IQ OQ PQ services in the San Francisco Bay Area or equipment qualification services elsewhere in California? Share your location and operating window. We confirm onsite coverage, scheduling, and travel. Pharmaceutical validation consulting in California can also include document review and project planning.
05 SCOPE-BASED PRICING
What does equipment qualification cost?
Cost depends on equipment complexity, qualification stages, document readiness, execution time, and site support. Your quote separates included work from optional or additional activities.
Start with your equipment and intended use.
Send your equipment details, intended use, current status, existing records, location, and target release date. Tell us whether you need writing, execution, or completion of an existing project.
Frequently asked questions
Ready to plan your qualification project?
Tell us what needs qualification, what has changed, and when you need it ready. We’ll help define the protocols, onsite work, and deliverables for a clear project quotation.