EXPERt SYSTEM VALIDATION engineering and Auditing SOLUTIONS for regulated organizations
SAVE-CO, LLC
Specialized consulting for pharmaceutical and biotech manufacturing, delivering high-stakes regulatory compliance and AI-driven automation auditing.
Our Story
About us
It's all about data because data tells a story about persons, products, performances, and just about anything. We have been around since 2000 providing engineering services for pharma, biotech, and medical device manufacturers. We worked hand in hand to ensure data generated by computerized systems is trustworthy, reliable, and adheres to 21 CFR Part 11 and ALCOA+++ standards.
We also support complex validation projects for electronic voting systems, ensuring end-to-end compliance, data integrity, and audit readiness.
We develop custom templates, requirements specification documents, and protocols that a regulated organization can approve, make effective and execute to assure their systems are fit for purpose. We also use Artificial Intelligence to verify compliance to a regulation, standard, or guidance document.
Engineering Services for Pharma, Biotech, and Medical Device Manufacturing
Comprehensive data security, data integrity, and data process mapping to help ensure your data is housed in a cybersecure vault.
01
PHARMA ARCHITECTURE
Specialized design of manufacturing control systems and biotech facility architecture to ensure scalable production and total regulatory adherence.
02
PHARMA SOFTWARE DEV
We build and integrate GxP-compliant software for pharmaceutical production lines and biotech automation. Our team implements custom digital architecture that ensures seamless data flow and manufacturing execution.
03
PHARMA COMMISSIONING
Specialized equipment qualification and testing services to ensure biotech systems meet cGMP and FDA standards.
04
VOTING SYSTEM AUDIT
Independent security auditing and regulatory assessments for election infrastructure and voting machine integrity.
05
E-VOTING V&V
Comprehensive validation protocols and rigorous test execution for voting machines to ensure secure documentation and election system integrity.
06
TECHNICAL CONSULTING
Expert advising on standards and risk for pharma and voting system lifecycles. We deliver cross-industry validation strategies that secure regulatory alignment.
AI PROTOCOLS
AI is used to analyze a single document or a batch of documents for compliance to a defined standard. Protocols are written to capture objective evidence that overall system and data integrity requirements have been satisfied.
DATA INTEGRITY • AI DOCUMENT ANALYSIS • COMPLIANCE PROTOCOLS • SYSTEM & CYBERSECURITY ASSURANCE
MINIMIZE FINDINGS. REDUCE COSTS.
VALIDATION OPTIMIZATION
Strategic process control systems installation, interfacing and commissioning designed to eliminate technical gaps and reduce validation cycles by up to 40%.
Verification and Validation of electronic / computer based USA Voting machines systems to ensure data integrity.
FDA COMPLIANCE
Comprehensive regulatory consulting ensuring adherence to 21 CFR Part 11 ER/ES, Part 820 QRMS, and Data Integrity. AI to analyze documents for compliance strengths and weaknesses. Complete custom executable protocols based on FDA and ISO requirements, including GAMP 5 guidelines.
OPERATIONAL IMPACT
High-stakes consulting services that minimize regulatory findings and reduce validation costs through rigorous testing and penetration testing based on defined requirements and NIST cybersecurity strategies.
ELECTRONIC VOTING SYSTEM VALIDATION
SAVE-CO, LLC provides independent, world-class expertise in auditing and validating voting machines and end-to-end election infrastructure to ensure absolute data integrity and regulatory compliance.
01
END-TO-END AUDIT TRAILS
We implement rigorous validation that ensures every vote is traceable from the point of entry to the final central tally.
02
NETWORK & SERVER HARDENING
Our cybersecurity experts perform comprehensive hardening of voting servers and networks against sophisticated cyber threats.
03
RISK-BASED TESTING
We employ NIST-aligned risk assessments to execute high-stakes penetration testing on all critical election systems.
CENTRALIZED
VOTING
INFRASTRUCTURE
VALIDATION
Connect With Our Experts
01. HEADQUARTERS
PO Box 128 Hwy 176
Pomaria, South Carolina 29126
02. Contact
Mike_Birochak @SAVE-CO.net
03. REGULATORY STANDARDS
FDA 21 CFR Part 11 (Electronic Records / Electronic Signatures)
FDA 21 CFR Part 820 QMSR (Medical Device)
ISO 13485:2016
NIST Cybersecurity Framework (CSF)
CIS Critical Security Controls
Custom documentation based on your system, product and process needs
Our solutions & document categories
Requirement Specifications
Detailed functional and technical requirements for regulated systems and equipment.
Validation
Comprehensive IQ/OQ/PQ protocols and summary reports for seamless GxP compliance.
Governance
Strategic framework for managing organizational data risk and regulatory oversight.
Data Integrity
Ensuring data is ALCOA++ compliant, trustworthy, and reliable throughout its lifecycle.
Cybersecurity
Risk-based security assessments and hardening strategies for sensitive infrastructure.
SOPs
Robust Standard Operating Procedures tailored to pharmaceutical and biotech operations.
Service One
Pharma: Custom developed documents detailing requirements, specifications, IQ / OQ / PQ testing, traceability index, and SOPs for purchase.
Service Two
E-Voting: Custom developed documents detailing requirements, specifications, IQ / OQ / PQ testing, traceability index, and SOPs for purchase.
Service Three
AI: We use our inhouse built AI application to verify how far apart or how close your QMS documents are to a regulation, standard, or guidance.
Service Four
Auditing: We perform mock FDA Pre-Audit Inspections to better prepare your organization for an FDA audit.