Olay Professional Pro-X vows ...

The evolution of validation – from paper to database

Author: Jeanne

Ever since the introduction of the PDA model for validation and its evolution into the GAMP V model, validation has been plagued with the reputation of being a paper intensive and burdensome process.

 

Regulatory agencies have come to expect a certain type and style of document evidence to support the validation process including a validation plan, requirements document and test protocols including the Installation, Operational and Performance qualifications.

 

In recent years, these documents have been enhanced with risk management and mitigation approaches but the end result is even more paper. Additionally, the necessity to show derived relationships between content in documents using a traceability matrix has added to the burden. For many organizations in the Life Sciences industry the traceability matrix has created significant workload in an attempt to derive ongoing value for validating patches, fixes and process or equipment changes prevalent throughout the life cycle of any system.

 

THINQ Compliance Inc formerly known as PENSA Technology Solutions Ltd

provides innovative compliance and validation solutions to pharmaceutical, blood products, medical device and other similar Life Sciences organizations. THINQ is a thought leader in computer system validation with a unique software application called THINQ Compliance Manager or TCM that can be combined with quality engineering consulting to deliver risk based and cost effective compliance solutions. THINQ's compliance experience extends to many mission critical software applications including ERP, LIMS, DMS, MES, PLMS and to compliance business processes including Sarbanes-Oxley, FDA and EU regulations, Payment Card Industry (PCI), HIPAA and HITEC. With over 20 years experience across drug and device regulated companies from Fortune 500 to Start-Ups, THINQ has also performed compliance best practices training, FDA audits, Policy development for electronic records and electronic security (e.g. 21CFRPart11). With the new release of TCM, THINQ is also positioned to help Life Sciences companies move from burdensome cost driven validation models to one that embodies a single, cost effect compliance system of record.

 

TCM changes the paradigm for validation being a burdensome paper intensive exercise to a cost effective process that provides a single system of record for all compliance content. Many traditional paper based tasks are automated including the generation of a complete traceability matrix for all content and a fully automated testing process that generates test evidence and stores it electronically. Full electronic signatures and audit trails are available within the compliance database. What’s more TCM is an industry proven solution that is available today especially when compared to existing tools on the market or when compared to the expense of building a solution from scratch.

 

The end result is a secure compliance content repository that provides best practice approaches for all types of system and equipment validation. With improved data management inherent in databases critical compliance information is available across the organization to be reused, measured and reported with a great degree of efficiency.

 

With TCM, validation has changed from a paper intensive mostly manual process into a competitive compliance solution that generates cost savings when compared to traditional approaches.

Article Source: http://www.articlesbase.com/technology-articles/the-evolution-of-validation-from-paper-to-database-1416232.html

About the Author

As a thought leader in compliance for the Life Sciences industry, THINQ provides compliance solutions to a broad range of pharmaceutical, medical device and biotechnology companies. For more information, visit: www.THINQcompliance. com


[TEMPLATE]Merchants Review[/TEMPLATE]

Tagged with: • • • • • • • • • •

Filed under: Wrinkles

Like this post? Subscribe to my RSS feed and get loads more!