Computer System Validation and Computer Software Assurance (CSV and CSA)

Computer System Validation (CSV)

Validation is an integral part of the pharma industry and must be done for every software that an organization uses. It is required to assess if the software complies with cGMP requirements. With technological advancement in the industry and more online and virtual processes in play, the potential risk of non-compliance is on the rise. In such scenarios, keeping track of periodical software updates might be challenging for manufacturers.

Freyr has expertise in performing progressive Computer System Validation (CSV) per the US FDA, EU, PIC/s, GAMP 5, ICH, WHO, 21 CFR Part 11, and EU Annex 11 requirements. Our CSV validation experts are experienced in handling simple to complex projects in modified Waterfall or Sprint methodologies. The quality gate review framework minimizes re-work in the product validation & vendor validation processes, and ensures total compliance at any stage during deployment, maintenance, and decommissioning.

• Progressive Computer Software Assurance (CSA) and validation per health authority guidelines
• Computer Software Assurance (CSA) and validation process/software process validation
• Software validation verification
• Compliance software solutions
• Software Regulatory compliance
• GMP software validation
• Process validation in pharma
• Process validation in manufacturing of biopharmaceuticals
• Computer System Validation (CSV) in the pharmaceutical industry
• Vendor audit services
• Accurate methodologies
• Pre-designated quality gates to minimize reworks
• Validation throughout the lifecycle
• Validation certificate
• Data security and compliance

Retro Validation

Legacy systems without proper validation are always a burden to an organization at the time of audit. Lack of proper documentation or workflows cannot withstand a Regulatory or customer audit. During such times, the best fit for your organization is to opt for an expert GAMP 5 software validation partner to retrospect the systems that are already defined and implemented.

Freyr’s experienced compliance and validation team performs retrospective validation and makes your existing system compliant with GAMP 5 computer system validation and ready to face any audit. We also analyze existing documentation and suggest required technicalities to fill the gaps in the documentation. Our team performs disaster risk assessment, medical software verification, and software audits.

Our validation services encompass the following activities:

• Retrospective validation for existing systems
• Analyzing gaps in existing documentation
• Expert validation support to fill the gaps
• Validation certificate

GxP and 21 CFR Part 11, EU Annex 11 (Electronic Record/Electronic Signature) Assessment:

At times, your organization’s system may be claimed as properly validated by vendors. However, with a lack of evidence or documentation and inadequate electronic signatures as part of the ERES assessment, they might be rated incompliant with GxP and ERES. Additionally, you might encounter an incomplete audit trail or you may never have tested your GxP business continuity and disaster recovery adequacy.

Freyr’s dedicated team performs assessments for existing systems and suggests practical remediation. Right from assessment to suggesting better solutions filling the gaps in existing systems and certifying them as on par with Regulatory guidelines, Freyr offers end-to-end validation support for customers that includes:

• GxP and ERES assessments
• Computer System Validation (CSV) and audit trail adequacy assessment
• FDA software validation services
• Business Continuity Management (BCM) & Disaster Recovery (DR) adequacy assessment
• Vendor audit and qualification assessment and manufacturing facility audit services