Whenever patient safety is involved, IT systems are subject to substantial regulatory compliance and strict adherence to applicable rules and regulations. Our focus is always on patient safety, product quality, and data integrity.

We offer a Scientific based Quality Risk Management approach to ensure projects are right sized for risk and ensure systems are fit for their intended use

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Quality as a Service

We have decades of experience helping our clients meet the challenges that can be addressed by way of an outsourced or managed services provider model.  We bring an extensive knowledge base of proven methods that ensure a repeatable and predictable approach to moving a business function to an MSP.  We achieve results that enable our clients to focus their resources on high value initiatives and position us as a true business partner.

Discover Quality as a Service, an outsourced model delivered as an Managed Service Provider.

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Audit and Inspection Readiness

Preparation is paramount to any audit, ensuring you have control over your processes, suppliers, and data.  All facilities must maintain a state of readiness. Many companies are outsourcing software and goods, it is the responsibility of the facility to endure the brunt of the consequences for violations found during an FDA inspection of the supplier’s facility. Our team can help by performing mock audits, documentation reviews, assist in staging information, and provide story boards.

See how organizations achieve quality and compliance.

We offer Quality as a Service, quality and compliance services offered in an outsourced model delivered as a Managed Service Provider (MSP), where our focus is always on patient safety, product quality and data integrity.

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Quality Review and Remediation

Best Practice quality processes will be used to help build your organizational needs. Our Quality and Compliance resources will ensure you regulatory requirements are being met.  We use industry standard experts help ensure patient safety and mitigate risk by remaining compliant to regulatory standards. Our teams are trained in regulatory requirements with a focus of GAMP 5 concepts, fit for purpose.

Learn about the importance of effective remediation of your validation activities how to ensure compliance

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Quality Management Systems (QMS)

QMS ensures GMP requirements are followed utilizing electronic solutions that are compliant, effective, efficient and continually improving. We’ll create a Compliance Program that includes high level policies for Quality Management and System Development Life Cycle (QMS). We can design a custom program specific for you or work within any of the industry standards. We can scale the QMS System to align with an organization’s purpose and strategic direction.

Click to see if you are prepared to achieve a successful FDA visit

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Computer Systems Validation (CSV)

Life Science organizations commit to CSV at different times and in different ways during their evolution. CSV is intended to ensure computer systems will produce information or data that meet defined requirements.  Our experienced resources can assist in establishing a framework set guidelines, safeguard controls, and mitigate risks. They can perform reviews and guidance to ensure the computer system is fit for the intended use.

Read about how implementing effective Quality Management Systems will ensure quality and compliance

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Consent Decree Remediation

Staying current with Regulations and Regulatory Guidelines can be challenging. Ensuring and sustaining regulatory compliance during a consent decree or even addressing Warning letters, FDA 483 Observations can be complex.  Our CSV & GAMP Trained and Experienced Resources including Certified Auditors on Staff can provide support and services during this situation.

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Data Integrity

Data integrity is the maintenance, assurance, data accuracy and consistency over its entire life-cycle.  Data Integrity is a critical aspect to the design, implementation, and usage of any system that stores, processes, or retrieves data. Risks to data integrity can be minimized or eliminated. Our experienced teams can help introduce processes to ensure Data Integrity is maintained.

We offer a Scientific based Quality Risk Management approach to ensure projects are right sized for risk and ensure systems are fit for their intended use.

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Periodic Review

Periodic Review of quality systems should be performed on a predefined schedule. Our experts can help create and maintain that schedule as well as perform the reviews. We take the effort away from your team and can fully manage the process end to end.

A well-defined Periodic Review should cover analysis of the application/process, of all the critical elements of the product life cycle.

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Deviation and CAPA Management

Deviation and CAPA systems exist so when ‘stuff happens’ the system and the people operating are there to assess the risk and protect the  patients and product. Incidents provide opportunity to learn from the experience and improve business processes. Our team of experts can assist in managing your Deviation and CAPA processes. They can drive the plans with your teams for resolution.

Our business and technology expertise can help you solve critical and complex challenges.

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