Whether it′s a greenfield project, a retrofit, or an upgrade, automation in the life sciences industry always includes three critical components (a) highly technical, proprietary processes, (b) timely completion (“speed to market”) and (c) regulatory compliance (e.g. FDA, EMEA, PMDA). As such, the control and information systems as well as instrumentation solutions followed regulations and industry standards in order to ensure timely delivery and full compliance.
PACIV company founders, directors and some of our associates worked for many years within the Life Science industry. We are well experienced in the Life Sciences’ regulated environment and the importance of ensuring that the systems we design, build, install, commission, validate and/or maintain satisfy your quality and regulatory compliance requirements, with significant focus on ensuring that the process parameters required to ensure accurate Safety, Identity, Strength, Purity, and Potency in your products is maintained. We understand that we play a key role within your manufacturing systems to ensure accessibility to your products within the market at the expected quality.
PACIV provides a powerful combination of automation, instrumentation and validation knowledge and experience. For over 15 years we have been engineering and implementing manufacturing and process automation projects of all sizes and types for the world's leading pharmaceutical and biotechnology companies. We follow industry “System Development Life Cycle” (SDLC) processes under industry guidelines (ISA S95/S88.1, ISPE GAMP™ to and C&Q BG5, ASTM E2500) to ensure our solutions are delivered as required and that they are designed, built/constructed, installed, commissioned, validated, operated, maintained and retired following our clients’ regulatory frameworks and business risks. In the Life Sciences regulated environment, not all risks are equal. PACIV has the needed knowledge and industry experience as to properly identify potential risk and mitigate them accordingly to ensure a Risk Based Approach while delivering our clients solutions.
The life science industry and its automation solutions distinguished itself for being forward thinking, leading edge technologies, that must be delivered and operated within a regulatory process and environment. Ensuring consistent performance of regulatory approved and proprietary processes from one batch to the next is of paramount importance within the industry. The products produced by this industry follow complex and proprietary processes that produced significant value for our clients and its customers, many of them lifesaving to the end user.
The three sectors within the Life Science industry that we focus on are:
To meet the need of our Life Sciences clients, PACIV provides its industrial automation, instrumentation and validation solutions within a collaborative model with its clients to achieve the following: