Computer System Validation and Computer Software Assurance - Overview

Is your software product on par with the global Regulatory requirements? Has it been evaluated for successful functioning? How many quality gates did it come through for a final compliant version? Did it complete all the stages of the software development lifecycle? If you are puzzled by these queries, validation should be the answer. Whenever software/a system is built or planned for development, Computer Software Assurance (CSA) is an integral part to be considered. Organizations should validate their products per the regulations such as 21 CFR Part 11 Software Validation, 21 CFR 820 Software Validation, and GAMP 5 Computer System Validation. Right from building software to reaching compliant versions, organizations may, sometimes, face difficulties in completing the entire validation lifecycle.

As the industry is gearing up to move away from traditional Computer System Validation (CSV) to Computer Software Assurance (CSA), Freyr can prepare you for a seamless transition. With an in-house compliance team, Freyr supports organizations to perform software verification and validation, Computer System Validation (CSV), pharma Computer Software Assurance (CSA), pharma CSV, and periodical process and product validation. Freyr establishes documental evidence throughout the lifecycle. From large projects to mid-size and temporary requirements, Freyr works  with clients from concept to developing software to ensure the clients’ products meet necessary Regulatory requirements.

Freyr’s validation capabilities include:


Computer System Validation - Freyr Expertise

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 whether the software is in line with cGMP requirements or not. With technological advancement in the pharma industry and more online and virtualized processes in play, the potential risk of non-compliance is also on the rise. In such scenarios, keeping track of periodical software development updates might be challenging for manufacturers.

Freyr has expertise in performing progressive Computer System Validation (CSV) as per the USFDA, EU, PIC/s, GAMP 5, ICH, WHO, 21 CFR Part 11, and EU Annex 11 requirements. Freyr’s 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 process & vendor validation process and ensures total compliance at any stage during deployment, maintenance, and decommissioning.

  • Progressive Computer Software Assurance (CSA) and Validation as 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.
  • Software Validation 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 would not 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 in the run.

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. En route, we analyze existing documentation and suggest required technicalities to fill the gaps in the documentation. We also perform 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 might have been claimed as properly validated by vendors. But 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 there might be chances that you never tested your GxP business continuity and disaster recovery adequacy.

Freyr’s dedicated team performs assessments for existing systems and suggests practicable remediation. Right from assessment to suggesting better solutions and 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 Assessment and ERES Assessment.
  • Computer System Validation (CSV) and Audit Trail Adequacy Assessment.
  • FDA Software Validation Services.
  • Business Continuity Management (BCM) & Disaster Recovery (DR) Adequacy Assessment.
  • Vendor Audit Services - Vendor Audit and Qualification Assessment and Manufacturing Facility Audit Services.

Computer System Validation - Freyr Advantages

  • Ensuring product quality, Regulatory compliance, patient safety, data integrity and security
  • Experienced and practicing professionals
  • Integrated process models
  • Effective and compliant business processes
  • Proven qualification strategies and validation services for life sciences industries
  • Quick turnaround timeframes
  • Significant cost savings