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Email: [email protected] Tel. (toll free) : 1-877-ADB-CCRO Tel. (local) : 954-517-1970
8569 Pines Blvd, Suite 215 Hollywood, FL 33024
Supporting manufacturing and logistics systems,
such as those that involve SAP, PeopleSoft,
Microsoft Dynamics, and QAD.
RunningRunning clinical database systems such as Oracle
Clinical, ClinTrials, MetaData, SAS, RDC, DataFax,
image management systems, labs management
systems, adverse event management systems,
coding management systems, thesaurus
management systems, MEDDRA, WHODRUG,
WHOART, clinical study management, and trial
management.management.
Incorporating System development life cycle
assessment comprising concepts, design,
implementation, installation, integration, and
maintenance.
Standardizing operating procedure and qualification
protocol development.
Validating packaging lines, Assembly, Automated
Testing Systems, manufacturing systems, end of
line testers, reliability systems, and in-process
systems which include validation of oxygen level
pacemakers with 8-bit micro-controllers.
ImplementingImplementing documentation testing and evaluation
standards pursuant to IEEE,FDA & ISO standards,
such as ISO 13485.
Meeting FDA product development and
manufacturing regulations for diagnostic,
implantable, Class I, II, III medical devices, Biologics
and meeting related industry regulations such as
AAMI, AIMD, ICH, MDD, ISO, CFR and IEC.
MaintainingMaintaining documentation revision control using
object oriented control systems including
Documentum®, Agile PLM®, SharePoint®, Scripts,
and Master Control.
SupportingSupporting quality assurance processes, corrective
and preventative actions, complaints, issues, field
service, non-conformance, supplier, receiving
inspection, and device accountability, packaging and
transportation, product traceability, return goods
systems, manufacturing, audits, and training
systems.
AdheringAdhering to FDA warning mitigations, including FDA
21 CFR Part 11, FDA 21 CFR Part 211, 49 CFR and
FDA 21 CFR Part 820.
Automation and Validation Groupwww.automationandvalidation.com
Automation and Validation GroupADBADB
Non-Product Software Validation
ADB Automation and Validation Group offers our experience in the establishment and execution of non-product software validation processes to support Medical Device and
Pharmaceutical Companies, among other sectors. To this end, we possess knowledge and experience in the following areas:
10 20142004EST.
