Compliance & Validation
GDPR, ISO, CFR, FDA and ITAR validation and compliance done right. Comprehensive validation and compliance made easy and cost effective.
Easily achieve regulatory and internal governance compliance to improve customer experiences, quality and cost reduction.
Reduce the risk of fines or reputational damage while growing trust with key stakeholders.
Drive Strategic Growth
Free resources to focus on achieving objectives with the support of global, standardized and compliant operations.
Compliance as a Service.
What is Compliance as a Service?
Staying current with regulatory changes, internal security and information governance protocols and requirements for technology validation and compliance is hard work.
It’s estimated that regulatory costs will go up by 200% in the next several years, creating unanticipated expense for businesses. Old compliance models and tools are ill-equipped to meet an ever-changing compliance requirement.
Whereas in the past compliance was largely seen as a periodic “one and done” exercise, today’s compliance requirements are ongoing and real-time.
Compounding the issue is the adoption of new technologies, creating opportunities for business risk due to poor compliance data quality and a lack of standardization. Today’s compliance requires:
- Risk Assessment: Discovery of GxP critical and business critical compliance risk areas
- Test Strategy: Identifying the tasks, leadership, objectives and metrics scope
- Validation Planning: Determining the business processes, platforms and technology to be tested
- Compliance Testing: Auditing and testing practices and processes, platforms and technology for regulatory requirement compliance
- Record Retention: Documenting strategies, tested platforms, technologies and processes, resultant actions and validation outcomes and a compliance scorecard for future audit needs
PCG quickly and effectively delivers compliance peace of mind for internal governance and external regulatory standards such as:
- FDA 21, Part 11 and 820
Compliance as a Service solves the technology compliance problem, keeping regulated and governed businesses out of trouble.
PCG’s Compliance as a Service is a process and tool suite that ensures technology compliance and governance challenges don’t hold your business back.
PCG Compliance Benefits—
- Knowing that your business is in compliance
- Keeping current with regulatory changes
- Increasing internal governance alignment
- Finding compliance risks before they become problems
- Having a pragmatic compliance strategy and plan
- Standardized testing and validation protocols
- Auditable testing and validation documentation
- Compliance traceability
- Compliance management education
Download FDA CFR Part 21 Brochure
Comprehensive Validation of these Platforms.
Make sure you’re fully GDPR, ISO, ITAR, CFR and FDA compliant before you run into trouble.
Traditional technology compliance testing and validation can lead to slow and unpredictable outcomes.
Compliance as a Service makes sure your platforms and applications are compliant to regulation or internal governance requirements.