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 software development life cycle? If you are puzzled with the aforementioned queries, validation should be the answer. Whenever a software/system is built or planned for development, validation is an integral part to be looked upon. Organizations should basically check these points to certify your product is properly validated. Right from building a software to reaching compliant version, organizations may, sometimes, face difficulties in completing the entire validation life cycle.

With an expert in-house compliance team, Freyr supports organizations to validate their software products periodically and establishes a 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 their products meet necessary Regulatory requirements.

 

Freyr Expertise

Computer System Validation

As an integral part of 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 current Good Manufacturing Practices (cGMP) requirements or not. With the technological advancement of Pharma industry, the potential risk of non-compliance is also on the rise with more of online and virtualized processes. 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 as per the United States Food and Drug Administration (USFDA), Europe, Pharmaceutical Inspection Cooperation Scheme(PIC/S), Good Automated Manufacturing Practice (GAMP) 5, ICH, World Health Organization (WHO), 21 CFR Part 11 and Europe Annex 11. The Computer system validation 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 and ensures total compliance and validation at any stage during deployment, maintenance and decommission.

  • Progressive software validation as per health authority (HA) guidelines
  • Accurate methodologies for effective validation
  • Pre-designated quality gates to minimize re-works
  • Validation throughout the life cycle
  • Validation certificate

Retro Validation

Legacy systems without a proper validation are always a burden to organizations at the time of audits. 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 validation partner to retrospect the systems which are already defined and in run.

Freyr with an experienced compliance and validation team performs retrospective validation and make your existing system compliant and ready to face any audit. Enroute we undertake analysing existing documentation and suggest required technicalities to fill the gaps in the documentation.

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

Temporary Engagements

At times, your organizations’ system might have been claimed as properly validated by vendors. But with lack of evidence or documentation and with inadequate electronic signatures, they might be rated as incompliant with GxP and Electronic Record/Electronic Signature (ERES). In addition, you might encounter 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.

  • GxP assessment, ERES assessment
  • CSV (Computer System Validation), Audit trail adequacy assessment
  • BCM (Business Continuity Management) & DR (Disaster Recovery) adequacy assessment

 

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 validation and qualification strategies
  • Quick turnaround timeframes (TAT)
  • Significant cost savings