With the advance of technology, companies are employing more complex and more critical software systems to automate processes across the enterprise. Many of the companies have had the experience of spending too much of their budget in the wrong places and too little in the right places. As regulatory auditors become more and more systems savvy, pharma companies' regulatory exposure is increasing. These situations can result in higher risk to patient, company, and data integrity needs and also non-compliance costs.
We provide the life science community with Subject Matter Expert (SME) knowledge resources to support activities involved in System Life Cycle (SLC) processes. From the GAMP 5 perspective, these are embedded in four life cycle phases that include concept, project, operation, and retirement. These phases encompass all traditional lifecycle processes, such as initiation, specification, design, build, test/validation, operation, maintenance and retirement.
We can help you with the full life cycle of software implementations, such as QMS, DMS, SAP / ERP, LIMS which includs building a foundation, choosing a system, auditing vendors, building the internal team, Validation, system rollout, system maintenance, and vendor management.