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.

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 Punch list resolution

Together with our validation capabilities, we leverage commissioning and Factory Acceptance Testing (FAT) processes to reduce the time and effort required for validation.

Training

Our staff has provided customized training on

cGxPs Validation Part 11 and other Compliance related activities

Computer Validation

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)

Emerson DeltaV ®, Siemens APACS, Fisher Provox ®, ABB Bailey Infi90

• Building Automation Systems (BAS)

Siemens, Andover, Honeywell

• Human Machine Interfaces (HMIs)
  

iFIX, FIX32, RSView, FactoryTalk View, InTouch

Laboratory System Validation

• HPLCs

Agilent, Shimadzu, Dionex

• FT-IR

Nicolet

• pH Meter

Mettler Toledo

Enterprise IT Systems

• Enterprise Resource Planning (ERP)

SAP, Oracle

• Lab Information Management System (LIMS)

Sample Manager, Beckman

• Electronic Document Mgmt System (EDMS)
  

Documentum

• Computerized Main. Mgmt. System (CMMS)

  Maximo, Champs

• Training

Isotrain

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