Compliance Management in BioTech & Pharma

Get your non-compliance risk under control

Bringing medical, pharmaceutical and biopharmaceutical products to market is a complex and high-risk race. The inherent risks of this industry require vast resources to successfully make the market. The need to comply with an increasing number of regulatory guidelines has been a challenge companies have and will continue to face.
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At Arrayo, compliance management is achieved through defining a client specific compliance management processes using a risk-based approach. This allows our team to identify requirements, assess current state of compliance, assess risks and potential costs of non-compliance against projected expenses to achieve compliance, and then prioritize, fund and initiate any corrective actions deemed necessary.

As more stringent and complex regulations will continue to impact and dictate quality management decisions in industries such as pharmaceuticals and medical device, it is becoming increasingly important to manage and control these compliance risks. However, as technology rapidly evolves there is a need for use-case based compliance that governing bodies like the FDA are more open to in recent times.

At Arrayo, we build a common framework and an integrated approach that manages all compliance requirements and control initiatives across an entire organization or for a specific new technology. We support our clients in centralizing, streamlining and standardizing quality process data and content from the whole value chain, providing those accountable for making decisions with a rounded perspective that would otherwise be hard to gain.

Our assignments span from Quality Systems implementation including Audit, Assessment, CAPA, Change Control, Non-Conformance, Deviation, Investigations, Environmental Monitoring to Customer Complaints.

We provide services that cover all stages of the life cycle of a computerized system in order to meet audit and regulatory requirements. Our computer system validation (CSV) consultants help you define and standardize your CSV policies and procedures to create a lighter weight process, perform audit readiness assessments, identify compliance gaps and provide advice on process improvement and remedial actions.

We generally advise on the CSV strategy and furthermore build a plan to meet our client’s goals. We leverage our client’s GMP policies to be used in a GLP or GCP context. We work with Clinical and Lab business users and get to understand their needs, help gather user & testable requirements. We define CSV frameworks and write documentation consistent with it, including validation, test plans and reports for validated environments. We often work on different systems simultaneously, in a holistic way. We review vendor documentation and evaluate how much of extra validation work needs to be scheduled for a specific vendor, which usually depends on the quality of the vendor’s documentation and the quality of internal policies. Moreover, we educate users and help them understand the need for validation.

At Arrayo, we especially provide services at the intersection of Clinical and Digital organizations. We manage and administer clinical systems and have experience deploying site training portals, SFTP file shares, IAM platforms, Veeva ETMF, etc. These systems need CSV expertise that we can deliver to our clients. Many of the clinical systems we have experience with are SaaS platforms.

On the lab front Arrayo has experience validating bioinformatics pipelines and system for clinical use. Thanks to our expertise at the intersection of technology, bioinformatics and regulatory compliance we provide our clients with quality documentation, operating requirements and access controls. Expertise in clinical bioinformatics pipelines spans from gene editing therapeutics to immune-oncology and liquid oncology diagnostics. Looking at the intended use of such applications, pipelines need to meet 21 CFR 11 and GxP compliance under GAMP-5 standards for validation.

We support our clients in designing enterprise-wide change control systems to keep your validated systems under control and comply with change management regulations. We also help in initiating and owning Change Control Records to introduce changes in a controlled and coordinated manner that minimize disruption while ensuring compliance with industry regulations. Arrayo accompanies organizations in designing, standardizing and implementing Change Control across the whole process, from change request to implementation of the change.

Validated Clinical Pipelines

Bringing pharmaceutical and biopharmaceutical pipelines from research to a validated product is a complex process.

At Arrayo our team of high caliber professionals make it possible. Team Arrayo specializes in taking research and development workflows and scaling our client’s scientific data analytics in validated on-prem, cloud-based, and hybrid instances. We have industry expertise developing validated clinical pipelines in all areas of research. Arrayo has industry expertise in not only developing validated bioinformatics pipelines, but also in bringing existing pipelines and systems into a validated state for clinical use. Expertise in clinical bioinformatics pipelines spans from gene editing therapeutics to immuno-oncology and liquid biopsy diagnostics. Looking at the intended use of such applications, pipelines need to meet 21 CFR part 11 and GxP compliance under GAMP-5 standards for validation.

We understand the needs of downstream validations that must fit with the architecture of a data platform and provide critical insights at the inception of a data management project. It is vitally important that all contributors in the development of a clinically valid system follow a tightly controlled process for the way in which data and security credentials are handled. All these components require support systems, informatics and an experienced data science team to expedite trials, select appropriate patients and bring life changing diagnostics and medications to patients faster.

At Arrayo, we uniquely combine industry knowledge, science, analytics and IT expertise that allow our teams to provide high impact services that drive business performance.

We combine functional and technical expertise to ensure risk management and regulatory demands are met, using the best-of-breed technologies and analytical applications.