Computer System Validation (CSV) & Assurance (CSA)

At Qualipharma, we offer comprehensive support in Computer System Validation (CSV & CSA) and digitalization projects. We ensure that your IT systems are validated, comply with quality standards, and maintain data integrity throughout the entire system lifecycle, following GxP, FDA, and ISO 13485 regulations. Our goal is to prepare you to face the challenges of digital transformation safely and efficiently.

We accompany your company throughout the entire lifecycle of digitalized systems, providing a comprehensive service that ensures validation and regulatory compliance at every stage of the process.

At Qualipharma, we provide our clients with the expertise gained from years of involvement in digitalization projects, offering services such as:

  • Advisory services in solution search
  • Evaluation and auditing of solutions and implementers
  • Project management
  • Full integration into the client’s project team
  • Support and development of User Requirements (URS)
  • Definition of validation strategies and methodologies integrated into the verification activities of the solution developed by the implementer, reducing validation effort, time, and associated costs (CSA)
  • Support in the evaluation and selection of implementers
  • Assistance in the requirement development process and review of functional and design documentation
  • Support in the drafting and management of Standard Operating Procedures (SOPs) for the solution

We provide support in computerized system validation through risk management, supplier audits, and the definition of key specifications (URS, FS, DS, etc.). Additionally, we manage data migration and the safe decommissioning of systems, equipment, or infrastructures at the end of their lifecycle.

Physical and logical security policy for systems

  • System maintenance policy
  • Backup and data restoration policy; as well as verification of backup execution and restoration
  • Computerized system validation policy

We handle the implementation or improvement of the quality system that facilitates system development in accordance with the regulations and standards applicable to the GxP environment or provide targeted support at various stages of your system’s lifecycle.

  • Development of Functional Analysis or Specifications
  • Development of different levels of Design Specifications: hardware, software, modules, units, etc.
  • Code review
  • Supplier management
  • Version control
  • Change control during development
  • Development of manuals, technical requirements, installation guides, 
  • We develop IT quality systems, policies, and procedures that include system validation, physical and logical security, and the periodic review of critical systems.
  • Systems Life Cycle Policy 
  • Factory Acceptance Testing (FAT)
  • Site Acceptance Testing (SAT) at the client’s premises and/or User Acceptance Testing (UAT)

We help you comply with regulations such as GDPR, NIS2, FDA 21 CFR Part 11, ISO 27001, and NIST CSF, to minimize the risk of cyberattacks and ensure data security and operational continuity at all stages.

Cybersecurity Assessment and Diagnosis

  • Risk analysis according to ISO 27005 and the NIST Risk Management Framework.
  • Compliance audit for GMP Annex 11, 21 CFR Part 11, GDPR, NIS2, HIPAA, and NIST CSF.
  • Vulnerability assessment in networks, systems, and industrial devices (OT/ICS).
  • Penetration testing (Pentesting) in IT and OT infrastructures.

 

Implementation of Security Measures

  • Development of an Information Security Management System (ISMS) in compliance with ISO/IEC 27001.
  • Implementation of access controls, multifactor authentication (MFA), and data encryption.
  • Security in cloud computing environments according to CSA (Cloud Security Alliance) guidelines.
  • Protection of electronic records and digital signatures in compliance with 21 CFR Part 11.

 

Incident Management and Response to Cyberattacks

  • Design of an Incident Response Plan (IRP) based on NIST 800-61.
  • Implementation of a Security Operations Center (SOC) with real-time monitoring.
  • Cyberattack simulations and Red Team vs. Blue Team exercises.

 

Regulatory Compliance and Training

  • Advisory in preparation for regulatory audits (FDA, EMA, AEMPS).
  • Training for employees on cybersecurity awareness and sensitive data management.
  • Creation of IT security policies and procedures..

 

Security in Production Systems and Validation

Validation of computerized systems in accordance with GAMP 5.

  • Protection of production equipment and SCADA in pharmaceutical environments.
  • Auditing and improvement of cybersecurity in the supply chain.

We develop validation projects according to the requirements of various regulatory agencies (EMEA, FDA, MHRA, ANVISA, CADTH, etc.), guidelines and standards (ISPE GAMP 5, ASTM 2500, etc.), and based on risk management tools necessary for identifying potential risks and streamlining the validation effort. We also have the capacity to integrate into project teams to apply an approach in line with the current trends in Computer System Assurance (CSA).

  • ERP (SAP, SAPBO, NAVISION, SAGE, UNIT4, ETC…)
  • QMS (VERIFARMA, VIS, SHAREME, QUONEXT, QUALITY FORWARD, QUMAS, ETC…)
  • WMS/WES/WCS (ULMA, V10, DEMATIC, IP6, V10, ETC…)
  • ELEARNING
  • PhV
  • MES
  • EBRS
  • W&D
  • HISTORIAN
  • PRODUCTION EQUIPMENT
  • TRACK & TRACE SYSTEMS (L1-L5)
  • REACTORS DCS
  • ETC
  •  
  • LIMS (LABWARE, NuGenesis, Sample Manager)
  • ELN
  • CHROMATOGRAPHY (EMPOWER, OPENLAB)
  • UV
  • IR
  • MASS
  • ETC
  • SCADA – EMS  
  • SCADA – BMS  
  • HMI
  • PROCESS CONTROL 
  • REACTORS DCS.
  • ENVIRONMENTAL REGISTRY CLOUD
  • ETC.

We ensure that the IT infrastructure supporting the systems meets regulatory requirements, guaranteeing data integrity, security, and the continuity of operations and business.

  •  Definition of the Qualification Plan
  • Development of Requirements and Specifications (HDS & SDS)
  • Verification and characterization of elements: physical servers, virtualization systems, storage systems (NAS & SAN), switches, routers, firewalls, access points, cabling certification, monitoring and diagnostic tools, server rooms, etc.
  • LDAP verification
  • Virtualization verification
  • Security and integrity of communication devices and infrastructure management
  • Communication verification
  • Backup and restoration management
  • Monitoring and diagnostic verification
  • Procedures verification
  • Etc.

Certify your talent in the industry at Computer System Validation (CSV) & Assurance (CSA) with our catalog of courses in both in-person and online formats. Discover e-learning by Qualipharma.

We guarantee the data integrity of all processes, both in manual and electronic operations and records within the company, to ensure that the data is complete, consistent, and accurate throughout its lifecycle; in relation to the practices and measures applied to maintain its security, accuracy, and consistency.

We conduct a comprehensive assessment of all company processes, managed both manually with paper records and through systems with electronic records, as well as the available policies and procedures; verifying compliance with data integrity principles.

After completing the process assessment, we develop a GAP Analysis, detailing all non-compliance and identified improvements, including a risk analysis of these to establish the potential impact and associated risks.

We address any non-compliance in data integrity through the action plan, ensuring the correction or improvement of the gaps identified in the assessment, including the prioritization levels for resolving each based on their risk level.

We are responsible for developing data integrity policies, as well as updating the procedures related to compliance with data integrity principles across various key areas such as Quality Assurance, Quality Control, IT, Production, etc.

Certify your talent in the industry at Computer System Validation (CSV) & Assurance (CSA) with our catalog of courses in both in-person and online formats. Discover e-learning by Qualipharma.

Everything starts with a hello!

Tell us what you need, and our team will find the most suitable solution for your project.

Contact
blog

To Read and Learn

See all

Stay up to date with the latest news in the pharmaceutical industry, regulations, and the innovative solutions we offer at Qualipharma.

See all
Linkedin-in
Youtube
Business units
Contact
Subscribe to the newsletter

Designed and developed by BlackBeast | Legal notice | Privacy policy | Cookies policy | Complaints channel