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REGULATORY SERVICES
Compliance Services
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 with minimal issues.
Regulatory Consulting Services
Our services include providing assistance to our clients to prepare for inspections from regulatory bodies such as
- FDA
- HCA
- EMEA
Audits
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.
Commissioning
We have extensive experience with commissioning and startup of new or existing facilities. Activities include
- Assembly of project and system manuals
- Training
- Procedure development
- Punchlist resolution
Training
Our staff has provided customized training on
- cGxP
- Validation
- Part 11
- and other Compliance related activities
Computer Validation
Aztec Consulting has the expertise and experieince to validate the most complex computer and control systems as well as the most complex enterprise-wide systems such as LIMS, EDMS or SAP. 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 |
Allen Bradley, GE, Modicon Delta V, Siemens APACS, Fisher Provox Siemens, Andover, Honeywell iFix, RSView |
| Laboratory System Validation |
Agilent, Shimadzu, Dionex Nicolet Mettler Toledo |
| Enterprise IT Systems |
|
SAP, Oracle Sample Manager, Beckman Documentum Maximo, Champs Isotrain |
IT Architecture Qualification
Aztec Consulting
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 proceudres
- Develop/Review Disaster Recovery procedures
- Develop/Review 21 CFR Part 11 procedures
21 CFR Part 11 Remediation
Our range of services encompass the following activities:
- Develop/Review Part 11 compliance strategy
- Perform Part 11 training
- Perform inventory
- Perform gap analysis
- Determine systems to be remdiated based on risk analysis
- Establish timeline and budget for systems to be remediated
- Remediate systems
- Perform validation of remediated systems