Case Studies

• Validation Accelerator Implementation Using Valkit for Clinical Tech Vendor

  Used Valkit to build a scalable, variable-driven validation accelerator that generates client-specific PQ packages from reusable IQ/OQ baselines.

• Fractional VP of Quality Enables Scalable Compliance and ISO 27001 Certification

  Provided embedded quality leadership for a regulated SaaS vendor, delivering operational maturity, audit readiness, and scalable compliance infrastructure.

• Digital Validation for Technology Vendor

  We guided our client, a SaaS software development company, through the transition to Valkit, a digital validation tool, and a new strategy to manage its IQ/OQ processes and deliverables. This combination allowed them to also better support their customers' PQ/UAT needs, which resulted in completing testing efficiently, facilitating more consistent schedule and budget attainment.

• ISO 27001 Certification for Laboratory Software Manufacturer

  Led ISO 27001 certification for a lab management software vendor serving regulated R&D, GLP, and GMP environments.

• System Implementation for Global Medical Information Call Center

  Implemented a validated system for global MedInfo operations, integrating with CRM/telephony platforms and improving response times by 25%.

• GxP Compliance Initiative for Major Biotechnology Sponsor

  Ensured GxP compliance and audit readiness by implementing a tailored QMS and risk-based CSV methodology aligned with GAMP 5.

• Case Study: ISO 27001 Certification Initiative for CellPort Software

  Background

  CellPort Software, a leading provider of clinical technology solutions, recognized the growing importance of robust information security practices to protect sensitive data and ensure compliance with industry standards. To strengthen its security posture and enhance its market reputation, CellPort embarked on a strategic initiative to achieve ISO 27001 certification. They engaged Driftpin Consulting to lead this comprehensive six-month certification project.

  Objectives

  • Achieve ISO 27001 certification within six months.
  • Develop and update necessary policies, procedures, and work instructions.
  • Establish and manage critical security and compliance processes.
  • Successfully navigate internal and external certification audits.
  • Ensure continuous improvement in information security management.

  Scope of Work

  Policy and Procedure Development

  • Added or updated 15 policies, 25 standard operating procedures (SOPs), and eight work instructions.
  • Key areas addressed included access control, data encryption, and incident response.

  Process Establishment and Management

  • Corrective and Preventive Actions (CAPA): Implemented a robust CAPA process to identify, document, and address security issues.
  • Change Management: Established a structured change management process to assess all changes for security impact.
  • Security Incident Management: Developed procedures for identifying, reporting, and managing security incidents.
  • Vulnerability Scanning: Introduced regular vulnerability scanning to proactively identify and mitigate security risks.
  • Business Continuity and Disaster Recovery: Created comprehensive plans to ensure operational resilience during disruptions.
  • Backup and Restore: Updated backup and restore procedures to ensure data integrity and availability.

  Audit Representation and Defense

  • Represented CellPort in internal audits, ensuring readiness and compliance.
  • Managed multiple external certification audits, providing documentation and addressing auditor queries.
  • Selected and managed an attack and penetration testing vendor to validate security controls.
  • Defended CellPort during the final certification audit, demonstrating the effectiveness of the Information Security Management System (ISMS) and achieving certification.

  Challenges

  • Communication to the Market: CellPort needed to effectively communicate its commitment to information security to build trust and enhance its market reputation.
  • Supplier Management: Managed multiple suppliers with significant roles in the certification process, ensuring all parties met required standards and timelines.
  • Resource Allocation: Consolidated substantial ISMS roles into a limited internal headcount. Developed a RACI matrix to distribute responsibilities effectively, avoiding overburdening specific resources and established an Executive Committee to provide hands-on review and oversight of all ISMS-related activity.

  Solutions and Outcomes

  Strategic Planning and Execution

  • Driftpin implemented a detailed project plan with clear milestones and responsibilities.
  • Regular progress reviews and adjustments ensured the project stayed on track.

  Collaboration and Communication

  • Driftpin established effective collaboration with CellPort’s teams and facilitated smooth implementation of new policies and procedures.
  • We instituted comprehensive training sessions that ensured staff were efficiently informed and compliant.
  • We created a communication plan that highlighted CellPort’s commitment to information security to external stakeholders.

  Audit Success

  • An internal audit, overseen by Driftpin, prepared CellPort for the rigorous external certification process.
  • Driftpin represented CellPort during external audits, ensuring all auditor queries were addressed promptly.

  Certification Achievement

  • CellPort Software successfully achieved ISO 27001 certification within the planned six-month timeline.

  By gaining ISO 27001 certification, CellPort:

• Case Study: Project Management for Implementation of a Med Info Management System

  Client: Medical Information Call Center

  Industry: Healthcare Services

  Project Scope: Configuration, implementation, and workflow process definition of a multi-client medical information management database application.

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  Background: Driftpin’s client is a leading medical information call center that serves over 50 global clients across various disease states and patient populations. The center receives, triages, and proposes calls from Health Care Providers (HCPs) and patients who submit medical inquiries, make product complaints, and report potential adverse events. To improve operational efficiency and compliance, the call center needed to implement a new, robust medical information management system - essentially a database application built to collect, triage, manage, track, and report on these interactions. The end users of the system are agents who are PharmDs and associated HCPs.

• Driftpin Case Study: Computer Software Validation for CellPort Software

  Background

  CellPort Software is a leading provider of lab management solutions. Their laboratory digitalization products are crucial for pharmaceutical and biotech companies aiming to expedite the development and approval of new therapies. A recent CellPort Software release targeted GxP clients and CellPort needed to ensure the release met the rigorous validation standards required by its user community. They enlisted Driftpin Consulting to develop the software validation strategy, project manage the validation process, and ensure compliance with regulatory requirements and alignment with client expectations.