Certified By
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Our team of professionals supports life science companies in all aspects of the CQV lifecycle.
We facilitate a timely and cost-effective solution tailored to your company’s budget and requirements
We are the largest commissioning, qualification, and validation service providers in the life science industry. Our CQV team consists of seasoned experts in validating facilities, utilities, equipment, computer systems, processes, cleaning, test methods, and more. Implify Inc. has the experts you need for services ranging from creating a validation protocol format, a validation master plan (VMP), training, technical audits, and due diligence to software validation, paperless validation, and more.
Our company has commissioning engineers to assist you in projects, large or small. Our engineers readily facilitate greenfield facility startup services and facility remediation services with integrated commissioning and qualification (ICQ), good automated manufacturing practice (GAMP), continued process verification (CPV), pre-Operational verifications, validation and verification (V&V), processed analytical technology (PAT) capabilities. We provide end-to-end solutions with expertise in project planning, CQV master planning, requirement specifications, risk assessments, commissioning, decommissioning, FATs, SATs, installation qualifications, operational qualifications, performance qualifications, summary reports, traceability matrix, calibration, temperature and humidity mapping services, and more.
Our consultants can access our global subject matter experts and training materials 24/7 and guarantee quality when delivering your projects. Our team of professionals can support your company in the entire CQV lifecycle. We facilitate a timely and cost-effective solution curated for your company. By outsourcing your CQV needs, you can focus on other aspects of your company while accelerating your business. While working with our company, your organization will continuously gain insightful knowledge to grow your company.
Computer systems can create, modify, and maintain documents to ensure accuracy, provide access and approve history, classify documents by use or type, and enable the ability to discern proper access and training.
Implementing an enterprise resource planning (ERP) system presents unique challenges and opportunities for companies of all sizes. ERP systems can represent a substantial financial investment, and proper planning and implementation of this foundation will provide seamless processes and insight to support strategic opportunities. Our consultants will guide you through the entire process, beginning with identifying company culture roadblocks, continuing to migrate data and resource silos, ensuring proper data security, and creating accurate reporting.
One-of-a-Kind Expertise to Address an Ever-Changing Industry
We have extensive experience validating laboratory equipment software in GMP and GLP environments, recognizing these instruments’ critical role in life sciences data’s overall quality and integrity. We excel in developing system inventories, performing risk assessments, determining remediation actions, and performing equipment qualification with software validation. We are highly experienced in leveraging vendor packages to minimize additional validation costs. Whether validating existing or new equipment software, our CSV team’s robust, risk-based approach ensures high-quality, cost- effective solutions.
Managing your calibration processes is vital to ensuring manufacturing continuity, efficiency, and compliance when performing thousands of calibrations annually. Paper-based systems are prone to human error, spreadsheets, and databases can’t provide insights into the data collection, and maintenance based on recommended intervals or historical trends can result in calibration activities when they’re not needed. The use of calibration management software can reduce costs, provide a more accurate analysis of historical trends, and optimize calibration intervals.
Our consultants will work with you to review your current procedures and documentation, identify gaps, manage calibration management software’s implementation and validation, and develop a training approach to maintain compliance moving forward. You can be confident that processes will be in place to ensure maintenance is scheduled and performed at the proper time, communications between equipment are working correctly, and the validation of instrument measurements are maintained and documented.