Services

Our services range from consultancy advice and supplementary validation to the actual validation and deployment process, helping clients to develop, validate and maintain IT and automation systems, as specified by current regulatory requirements related to the pharmaceutical, clinical study, biotech and medical device industries.

We offer assistance in the following key areas:

• Validation of computer based systems, including project management, validation planning, testing, training, execution and reporting.

• Compilation of CSV/CSA/CSQ system documentation suites for standalone and multi-client/site (LAN/WAN) based systems, tailored to match system complexity, including:

  • Compliance assessment, ER/ES assessment, validation plan, remediation plan, risk management, user requirements, functional design specification, IQ/OQ/PQ protocols, test plan, test scripts, test report, requirements traceability matrix, security plan, backup & restoration plan, business continuity plan, disaster recovery plan, retirement plan, vendor evaluation, configuration management, validation report, periodic review and system asset plan.

Competencies

• Manufacturing equipment validation

• Data Integrity

• MES, BMS & Facility monitoring

• Historian systems

• Laboratory analytical systems, robotic systems and e-laboratory validation

• LIMS, CDS & ELN validation

• Clinical trial study (edata) validation and DI (phase I, II & III)

• Cloud-based system validation

• Process validation

• Compilation of system requirements, principles, and methods for automation, risk management, analyses and methods, from facilitation during the initial project phases to execution of the entire system deployment process.

• System gap analysis for revalidation and/or remediation, ensuring regulatory compliance (21 CFR Part 11 & Part 820, Annex 11).

• System implementation in accordance with GAMP 5, including analysis of the customer's quality management system, preparation of document templates, choice of development model and training of personnel.

• System audits to determine compliance status of equipment, process, department and facility with following audit services are available:

  • Pre-inspection regulatory audits, prior to official MHRA, FDA or ISO inspections

  • Internal cGxP audits

  • External supplier qualification and post market monitoring audits