non product and fda software validation

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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.