Compliance Management in BioTech & Pharma

Achieve compliance, mitigate risk

Bringing medical products and pharmaceuticals to market is a complex and high-risk race. The need to comply with an increasing number of regulatory guidelines is a challenge companies will continue to face.
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RegTech constitutes our regulatory-driven services, dealing primarily with Computer System Compliance and Go-Live. Here, we handle GxP digital systems and execute on Computer System Validation – from validation strategy to validation execution, all the while ensuring that process controls and documentations are in place for regulatory compliance. Additionally, we implement Clinical, Regulatory, Medical Affairs, and Pharmacovigilance Digital Systems. We bring GxP digital systems to a production-ready state for operational usage and corporate Go-Live. Our team has experience dealing with the various vendors in the market today such as Veeva, Argus, BioClinica, etc. We also provide training and change management services to enable seamless user adoption.

As more stringent and complex regulations continue to dictate quality management decisions in the industry, it is becoming increasingly important to manage and control compliance risks. At Arrayo, we take an integrated approach that manages all compliance requirements and control initiatives across an entire organization or for a specific new technology.

Arrayo provides records and information management advisory, leveraging years of experience in regulatory-driven transformation projects and records governance expertise. Our services are focused on building and enhancing robust RIM programs to ensure that a comprehensive and scalable system is in place. We focus on drafting and implementing policies, records retention schedules, E-training courses, and maintenance schedules in addition to offering guidance on technology adoption. Our experts understand the various RIM systems on the market and can ensure the chosen system fits seamlessly into our client’s digital ecosystems.

Change Controls:
Arrayo supports our clients in designing, standardizing, and implementing enterprise-wide change controls. We help initiate and own Change Control Records to introduce changes in a coordinated manner, minimizing disruption while ensuring compliance with industry regulations.

Computer System Validation:
At Arrayo, we also provide services at the intersection of Clinical and Digital activities. We manage clinical systems and have experience deploying site training portals, SFTP file shares, IAM platforms, Veeva Vault, etc. Moreover, we have the requisite CSV expertise to accelerate the Go-Live of these systems.

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

Not only do we advise on CSV strategy, we also build a plan to meet our client’s goals. To this end, we:
- Leverage our client’s GMP policies to be used in a GLP or GCP context.
- Work with Clinical and Lab business users and get to understand their needs, as well as help gather user & testable requirements.
- Define CSV frameworks and write documentation consistent with it, including validation, test plans, and reports for validated environments.
- Use a risk-based approach to identify requirements, assess current state of compliance, emphasize on the intended use of the computerized system, and achieve use-case-based compliance. We evaluate how much of extra validation work needs to be scheduled for a specific vendor.
- Finally, we educate users and help them understand the need for validation.

Validated Clinical Pipelines

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

We have experience validating bioinformatics pipelines and system for clinical use. 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 a track record not only in developing validated bioinformatics pipelines, but also in validating existing pipelines and systems for clinical use. Our clinical bioinformatics pipelines expertise spans from gene editing therapeutics to immuno-oncology and liquid biopsy diagnostics. Based on the intended use of such applications, pipelines need to meet 21 CFR part 11 and GxP compliance under GAMP-5 standards for validation.

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

Our blend of functional and technical expertise helps ensure risk management and regulatory demands are met, using best-of-breed technologies and analytical applications.