CAVE Solutions, inc is a professional consulting firm specializing in the technical and commercial aspects of compliant services. Since its inception, CAVE has provided the industry with a reliable database, guides, and models for cross-functional organization and controls. We are predicated on maintaining a downstream lens to protect the patient and product quality.
CAVE offers an integrated system to manage compliance data that allows easy transitioning through engineering, construction, automation, and validation
CAVE Solution’s advisors are highly experienced in all aspects of pharmaceutical regulations going from business evaluation to process modeling, from technical design through construction, from facility release to first in kind, from equipment reliability to plant optimization. Our flexible organization, value-added minds, analytical strength, and highly skilled consultants allow us to invest upfront, organize upstream activities, and deliver defined outcomes that are reliable. ß
CAVE Solution’s is an end-to-end information provider in the space of startup and qualification of GMP systems and facilities. No two ecosystems are the same and we try to structure and organize the diversity of trades, vendors, and client to reduce time to market. Our project methodologies assess business and compliant risk to create the framework for a smooth project transition through the validation hour-glass.
Our project execution is focused on fulfilling URS requirements through stewardship of upstream deliverables
Identification and management of stage-gate inputs and timelines
As manufacturers transition from paper to paperless records and computerized systems as a way to better keep track of all the data that can be accumulated during the manufacture, testing and release of a product. If you have any computerized systems or electronic records on site you’ll have to comply with the regulatory requirements for Electronic Records and Electronic Signatures (ERES) as outlined in the US Code of Federal Regulations (CFR) Part 11, or those documented in EU or PIC/S Annex 11.
If you are considering a new computer system and are not sure if it’s suitable or not, we can review it against the current regulatory requirements to ensure it is compliant before you start implementation (or before you commit to purchasing and sign any contracts!).
If you have an existing system and you aren’t sure if it needs to be compliant or if it even can be made to be, we’ll review it and recommend any remediation actions that may be required in order to comply with the 21 CFR Part 11 or PIC/S Annex 11 requirements.
A common mistake is to ignore the predicate rules and incur unnecessary expense doing work that that is not required. It is still common to see over-elaboration on this requirement.
Putting the systems and documentation in place
During our work on Part 11 compliance with our customers, we’ve developed robust procedures and assessment templates for this area. We’ll ensure that you have the correct documentary evidence to ensure compliance with the CFR’s and regulatory requirements – making your next audit a success.