132 Central Street
Foxboro, MA 02035
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Our staff can provide regulated industries such as pharmaceutical and biotechnology with a range of services designed to improve compliance and enhance “inspectability.” Our personnel have experience with preparing facilities and systems for FDA, EMEA, HCA and other regulatory bodies. We provide practical solutions to compliance based on experience as a result of which our approach has been validated by 5 successful regulatory inspections.
Regulatory Consulting Services
Our services include providing assistance to our clients to prepare for inspections from regulatory bodies such as
We have expertise and experience in performing internal audits as well as vendor audits. At the end of an audit we provide our clients with concrete recommendations to remediate issues found during the audit.
Quality Documentation Program
Our staff has worked with clients to develop functional SOPs. We have also developed and reviewed change control procedures for some of our clients. Our expertise also encompasses development and review of validation programs as well as revalidation programs.
We have extensive experience with commissioning and startup of new or existing facilities. Activities include
Together with our validation capabilities, we leverage commissioning and Factory Acceptance Testing (FAT) processes to reduce the time and effort required for validation.
Our staff has provided customized training on
Aztec Technologies has the expertise and experience to validate the most complex computer and control systems as well as the most complex enterprise-wide systems such as LIMS, EDMS or ERP. We can supplement your internal computer validation resources with our personnel who have extensive experience with ever changing regulations. We combine experience and expertise with a risk based approach to computer validation. Our experience with systems includes the following:Manufacturing Automation Systems
- Programmable Logic Controllers (PLCs)
Allen Bradley, GE, Modicon
- Distributed Controls Systems (DCS)
- Building Automation Systems (BAS)
- Human Machine Interfaces (HMIs)
Emerson DeltaV ®, Siemens APACS, Fisher Provox ®, ABB Bailey Infi90
Siemens, Andover, Honeywell
iFIX, FIX32, RSView, FactoryTalk View, InTouch
Laboratory System Validation
Agilent, Shimadzu, Dionex
- pH Meter
- Enterprise Resource Planning (ERP)
- Lab Information Management System (LIMS)
- Electronic Document Mgmt System (EDMS)
Sample Manager, Beckman
- Computerized Main. Mgmt. System (CMMS)
IT Architecture Qualification
Aztec Technologies has provided the following services to some of our clients to ensure that their IT Infrastructure and systems are installed and operate in a compliant manner and can stand up to an "inspection".
- Review design of networks and ensure logical segregation of GxP segments from business segments.
- Develop / Review IT procedures for desktop deployments, operating system/application upgrades, inventory of GxP equipment, etc.
- Develop / Review Change Management procedures for GxP systems/applications
- Develop / Review system security procedures for compliance to Part 11
- Develop / Review data backup/recovery and retention procedures
- Develop / Review Disaster Recovery procedures
- Develop / Review 21 CFR Part 11 procedures
21 CFR Part 11 Remediation
Our range of services encompasses the following activities:
- Develop/Review Part 11 compliance strategy
- Perform Part 11 training
- Perform inventory
- Perform gap analysis
- Determine systems to be remediated based on risk analysis
- Establish timeline and budget for systems to be remediated
- Remediate systems
- Perform validation of remediated systems