ISO 27001 Certification for Laboratory Software Manufacturer

The Challenge

A leading lab software manufacturer needed to establish an ISO 27001-compliant Information Security Management System (ISMS) to meet regulatory expectations and signal maturity to pharma clients. With limited internal bandwidth and multiple vendors involved, the client required a partner to lead the certification process and mitigate audit risk without overburdening internal teams.

The Systematic Approach

Driftpin defined a phased certification roadmap and executed a comprehensive implementation of ISO 27001 policies, procedures, and governance structures. We embedded security practices into the client’s operations through SOPs, RACI matrices, and training. Regular checkpoints with executive leadership ensured visibility, accountability, and sustainable adoption.

Key Activities

  • Authored and deployed 15 policies, 25 SOPs, and 8 work instructions covering access control, encryption, incident response, and business continuity
  • Established core ISMS processes: CAPA, change control, vulnerability scanning, backup & restore, DR/BCP
  • Selected and managed external audit and penetration testing vendors
  • Represented the client during internal and external audits, addressing findings and defending the ISMS

The Transformation

The client transitioned from ad hoc security practices to a fully documented and governed ISMS aligned with ISO 27001. Security roles and responsibilities were clearly defined, staff were trained and equipped, and certification audits were passed without critical findings.

Measurable Outcomes

  • Certification achieved: ISO 27001 granted within the targeted 6-month timeline
  • Policy foundation: Over 45 security policies, SOPs, and work instructions deployed
  • Sustainable security: Embedded governance, training, and executive oversight across ISMS operations

Strategic Impact

Certification increased the client’s credibility with enterprise life sciences buyers, reduced regulatory risk, and created a foundation for secure, compliant growth in GMP and GLP environments. Driftpin continues to support surveillance audits and security program evolution.