Controlled Environments Services
Micronova/ICS QMS Audits and GAP Assessments
Micronova/ICS experts prepare and execute QMS audits and GAP assessments including site preparation, training internal staff, reporting, and responding to certified bodies (auditors).
Fisherbrand™ TraceableLIVE™ Subscription Coupon Codes
TraceableLIVE™ Subscription Coupon Codes with simplified cloud monitoring for critical environments.
Contec Disinfectant Selection and Optimization Support, Controlled Environments
This service provides expert guidance on selecting effective, compliant disinfectants for controlled environments and cleanrooms ensuring proper surface compatibility, microbial efficacy, and regulatory alignment while optimizing application methods and rotation strategies for contamination control.
Contec SOP for Cleaning and Disinfection Assistance and Guidance
Our service enhances cleaning and disinfection standard operating procedures (SOPs) by ensuring regulatory compliance, improving efficiency, reducing contamination risks, and optimizing resource use. It supports audit readiness, staff training, and consistent documentation to maintain controlled environments.
Micronova/ICS Equipment Qualification and Validation Service
The Micronova/ICS engineering team offers start-to-finish IQ/OQ/PQ resource support, from protocol write-ups, testing and final reports, to vendor selection and FAT/SAT activities, including project management.
Micronova/ICS Permanent Audit and Inspection Readiness Program
Partner with Micronova/ICS to prepare personnel for governmental inspections, including FDA and EMA. Experts will ensure your site and team are well-prepared for inspections and well-equipped to streamline audits.
Micronova/ICS Vendor Qualification
The Micronova/ICS team can onboard new vendors or maintain vendor standards, as well as conduct audits to include company requirements and standards. They will provide final reports and make recommendations following company procedures and processes.
Micronova/ICS IT Demand and Process Improvement Support
Micronova/ICS offers compliance-embedded long-term or short-term IT support for small and mid-sized companies who may not have an internal IT department or dedicated IT staff to implement and improve IT needs.
Micronova/ICS Data Integrity Solutions
Micronova/ICS provides a comprehensive Data Integrity solution built upon industry standards, including 21 CFR Part 11 and Annex 11. In addition, the on-site project team is available for data integrity projects and FDA/EU inspection preparations.
Micronova ICS ISO 27002 Implementation and Improvements
ISO implementation and improvement experts will guide your organization through achieving certification across all ISO standards, ensuring full compliance with current international requirements and best practices.
Micronova/ICS IT Validation and Project Management
IT validation projects, from isolated assistance to overall project management, can be facilitated with Micronova/ICS to cover all aspects to ensure a ready-to-use application including software identification, documentation, validation, and testing.
Micronova/ICS Annex 1 Implementation and Upkeep
Partner with Micronova/ICS to implement Annex 1 guidelines efficiently and effectively. Experts will advise on current guidelines and their seamless implementation within your organization.
Micronova/ICS Deviation and CAPA Investigation Support and Backlog Reduction
Partner with Micronova/ICS to reduce non-conformance and CAPA backlog challenges. Experts will provide analysis and work to eliminate backlog to equip your team for future success.
Micronova ICS ISO 14001 Implementation and Improvements
ISO implementation and improvement experts will guide your organization through achieving certification across all ISO standards, ensuring full compliance with current international requirements and best practices.
Micronova/ICS Contamination Control Strategy (CCS) Consulting Service
Partner with Micronova/ICS, through a tailored CCS Consulting Service to receive a custom-built Contamination Control Strategy along with implementation, training, and documentation for a wholistic approach towards achieving efficient and effective strategies.
- 1
- 2