| Ever since the introduction of the PDA model for | | | | compliance business processes including |
| validation and its evolution into the GAMP V | | | | Sarbanes-Oxley, FDA and EU regulations, Payment |
| model, validation has been plagued with the | | | | Card Industry (PCI), HIPAA and HITEC. With over |
| reputation of being a paper intensive and | | | | 20 years experience across drug and device |
| burdensome process. | | | | regulated companies from Fortune 500 to |
| | | | | Start-Ups, THINQ has also performed compliance |
| Regulatory agencies have come to expect a | | | | best practices training, FDA audits, Policy |
| certain type and style of document evidence to | | | | development for electronic records and electronic |
| support the validation process including a validation | | | | security (e.g. 21CFRPart11). With the new release |
| plan, requirements document and test protocols | | | | of TCM, THINQ is also positioned to help Life |
| including the Installation, Operational and | | | | Sciences companies move from burdensome cost |
| Performance qualifications. | | | | driven validation models to one that embodies a |
| | | | | single, cost effect compliance system of record. |
| In recent years, these documents have been | | | | |
| enhanced with risk management and mitigation | | | | TCM changes the paradigm for validation being a |
| approaches but the end result is even more | | | | burdensome paper intensive exercise to a cost |
| paper. Additionally, the necessity to show derived | | | | effective process that provides a single system |
| relationships between content in documents using | | | | of record for all compliance content. Many |
| a traceability matrix has added to the burden. For | | | | traditional paper based tasks are automated |
| many organizations in the Life Sciences industry | | | | including the generation of a complete traceability |
| the traceability matrix has created significant | | | | matrix for all content and a fully automated |
| workload in an attempt to derive ongoing value | | | | testing process that generates test evidence and |
| for validating patches, fixes and process or | | | | stores it electronically. Full electronic signatures and |
| equipment changes prevalent throughout the life | | | | audit trails are available within the compliance |
| cycle of any system. | | | | database. What’s more TCM is an industry |
| | | | | proven solution that is available today especially |
| THINQ Compliance Inc formerly known as PENSA | | | | when compared to existing tools on the market |
| Technology Solutions Ltdprovides innovative | | | | or when compared to the expense of building a |
| compliance and validation solutions to | | | | solution from scratch. |
| pharmaceutical, blood products, medical device and | | | | |
| other similar Life Sciences organizations. THINQ is | | | | The end result is a secure compliance content |
| a thought leader in computer system validation | | | | repository that provides best practice approaches |
| with a unique software application called THINQ | | | | for all types of system and equipment validation. |
| Compliance Manager or TCM that can be | | | | With improved data management inherent in |
| combined with quality engineering consulting to | | | | databases critical compliance information is |
| deliver risk based and cost effective compliance | | | | available across the organization to be reused, |
| solutions. THINQ's compliance experience extends | | | | measured and reported with a great degree of |
| to many mission critical software applications | | | | efficiency. |
| including ERP, LIMS, DMS, MES, PLMS and to | | | | |