Perspectives | Establish a clear and consistent understanding of Systems Compliance within your Pre-Clinical Laboratory Organization & Personnel.
Keeping pace with the rate of change of Information Technology is important for every business. As a result, Systems Compliance must be a practical and efficient process that is well understood across your organization. QAaaS-MI’s approach to Systems Compliance enables your organization to have the same conceptual understanding and creates clear separation of functional responsibility for personnel to establish practical procedures for work completion.
Test Facility Management
TFM has the responsibility to assure resources are available as scheduled for each study and that personnel clearly understand their functions. TFM has significant influence on the culture and operational approach of your organization, making its support a certain requirement for creating change. Due to the deeply embedded nature of Information Technology in Laboratory Operations, TFM is the beacon for establishing Systems Compliance as a cultural element in the organization and establishing consistency across the lab in its application.
Quality Assurance Unit
QAU has the responsibility to monitor and report conformance of laboratory operations to applicable regulations. This can often become a difficult and contentious task for Systems Compliance. It’s commonly misunderstood, resulting in lines of responsibility becoming blurred and leaving personnel lacking proper training and qualifications to complete tasks and not understanding how compliance applies. By establishing Systems Compliance as a cultural element to your organization, functional responsibilities will align to the correct personnel in addition to establishing a consistent conceptual understanding. As a result, QAU interactions with personnel become more efficient and risk of non-compliance will decline.
Information Technology Personnel
IT Personnel have a critical role in Systems Compliance when electronic records are involved, as per 21 CFR Part 11. They must assure equipment design is suitable for intended use. More commonly referred to as hardware and software, IT personnel not only need to know how to maintain these items within the facility in a compliant manner, but also need to be effective working with vendors to leverage their delivery and maintenance procedures. This capability is critical to minimize implementation time and enabling the business to become early adopters of IT innovation.
Application Owners
Application Owners have the opportunity to gain efficiency in Systems Compliance through reduced maintenance overhead and implementation time. QAaaS-MI can assist in developing time efficient strategies for training, SOP writing and validation testing. We can additionally help AOs understand how their system use is supported by the underlying solution qualification delivered by IT Personnel and vendor partners.
System Personnel
Delivery of Systems Compliance occurs through Personnel performing work, only through their diligence can expected results be achieved. This means alignment of that work to both process and technical controls of the system. Incorporating lessons learned from day to day experience is a potential benefit that can’t be overlooked and is necessary for effective risk approaches with increased efficiencies. System Personnel have the pragmatism to help shape Systems Compliance into a practical and efficient component of your laboratory operations. QAaaS-MI understands how to communicate across the levels and functions of GLP environments so you can create systems matching your business and regulatory targets.