Overview

Is your software product built on par with 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 with the aforementioned queries, Validation should be the answer. Whenever a software/system is built or planned for development, software validation is an integral part to be looked upon. Organizations should basically validate their products as 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 a software to reaching compliant version, 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 support you to prepare for a Seamless transition. With an expert in-house compliance team, Freyr supports organizations to perform Software Verification and Validation, Computer System Validation (CSV), Pharma Software Validation, Pharma Computer System Validation, and periodical Process and Product Validation. Freyr establishes documental evidence throughout the lifecycle. From large projects to mid-size to temporary requirements, Freyr works hand-in-hand with clients from a concept to software to ensure clients’ products meet necessary Regulatory requirements.

Freyr’s validation capabilities include:

 

Freyr Expertise

Computer System Validation (CSV)

As an integral part of the Pharma industry, Validation must be done for every software product that an organization uses. Validation is required to assess whether the software product is in line with cGMP requirements or not. With the technological advancement of the Pharma industry and with more of online and virtualized processes, the potential risk of non-compliance is also on the rise. In such scenarios, keeping track of periodical software development updates might be a challenging task for manufacturers.

Freyr has expertise in performing progressive Computer System Validation (CSV) as per USFDA, EU, PIC/s, GAMP 5, ICH, WHO, 21 CFR Part 11 and EU Annex 11. The CSV experts at Freyr are experienced in handling simple to complex projects in modified waterfall or sprint methodologies. The quality gate review framework minimizes re-work in Product Validation Process, Vendor Validation Process and ensures total Compliance and Validation at any stage during deployment, maintenance, and decommission.

  • Progressive Software Validation as per Health Authority Guidelines
  • Software 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 in Pharmaceutical Industry
  • Vendor Audit Services
  • Software Validation Services
  • Accurate Methodologies
  • Pre-designated Quality Gates to Minimize Re-works
  • Validation Throughout the Lifecycle
  • Validation Certificate
  • Data Security and Compliance

Retro Validation

Legacy systems without proper validation are always a burden to organization at the time of audit. Lack of proper documentation or workflow would not stand 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, which are already defined and in the run.

Freyr with an experienced compliance and validation team performs retrospective validation and makes your existing system compliant with GAMP Computer System Validation and ready to face any audit. Enroute we undertake analyzing existing documentation and suggest required technicalities to fill the gaps in the documentation. We also perform Disaster Risk Assessment, Medical Software Verification, and Software Audit Services.

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 lack of evidence or documentation and with inadequate electronic signatures as part of ERES Assessment, they might be rated as incompliant with GxP and ERES. In addition, you might encounter an incomplete audit trail or there might be chances that you never tested your GxP business continuity and disaster recovery adequacy, which might challenge you to proceed further in a compliant world.

Freyr, with a dedicated team for validation, performs assessments for existing systems and suggests practicable remediation. Right from assessment to suggesting better solutions to fill up the gaps in existing systems to certifying the systems on par with Regulatory guidelines. Freyr offers end-to-end validation support for customers that includes:

  • GxP Assessment, ERES (Electronic Record/Electronic Signature) Assessment
  • CSV (Computer System Validation), Audit Trail Adequacy Assessment
  • FDA Software Validation Services
  • BCM (Business Continuity Management) & DR (Disaster Recovery) Adequacy Assessment
  • Vendor Audit Services - Vendor Audit and Qualification Assessment Manufacturing Facility Audit Services

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