WakeUp to Quality's Services
CSA Implementation
Most companies think they have adopted CSA when in reality they have done little more than sprinkle in the CSA acronym and add in some verbiage on unscripted testing with no real guidance on when or how to use it.
WakeUp to Quality offers everything you need for a comprehensive and effective implementation, including the high-level governance, policy and procedural updates, test strategy generation, detailed training, and templates to empower your organization to truly realize all the benefits of CSA.
Charlie was an early leader in harmonizing GAMP and CSA approaches, beginning in 2019 with the collaboration between GAMP and the FDA Industry CSA team. She lead the first formal publication of CSA principles in the GAMP Data Integrity by Design Guide in 2020, followed by directing and generating the extensive guidance on Critical Thinking in the GAMP Enabling Innovation Guide in 2021 and spearheading the major revision to Appendix D5 of GAMP 5 Second Edition in 2022.
Computerized Systems Validation
Be confident your GxP systems are fit for intended use with expert validation assistance from WakeUp to Quality. Charlie combines critical thinking and pragmatic risk-based approaches with 25 years of practical experience to ensure your systems provide operational benefits while safeguarding patient safety, product quality and data integrity.
An assessment of your internal validation policies, practices and projects is also available.
Computerized Systems Quality Audits supporting CSV and CSA
Following the principles of EU and PIC/S Annex 11 on computerized systems, and leveraging in-depth knowledge and experience of GAMP guides, this computerized system quality audit will assess how the computerized system has been developed and how it is managed and maintained by the supplier ongoing. Assessments are often overlooked for lack of resource but are an essential foundation to successful use of CSA in your validation projects.
Data Integrity Assessments
Knowing ALCOA++ is just the starting point for data integrity; it also needs robust data governance and careful attention to data review practices. An end to end workflow assessment can identify vulnerabilities or areas for improvement in your data integrity approach.
Part 11 Assessment
1997 may seem a long time ago but 21 CFR Part 11 is just as important today as it was when first published. Suppliers are always keen to offer their assessment of how they claim their product meets the technical requirements for Part 11, but wouldn't you be more confident if you could review the findings from an independent assesssment instead?
Periodic Review
Implementing and validating a computerized system occurs early in the system lifecycle but it is equally as critical to maintain the validated state of the system through its operational life and the inevitable changes that will occur over that extended time of use. A Periodic Review, mandated by Annex 11, examines every aspect of the use and control of the system and provides a detailed report listing out any nonconformances and opportunities for improvement.
Process Mapping and Data Flows
If data loses its integrity at any point in your process, that integrity is lost forever. Most companies do well at addressing data integrity within an individual system but may not have a strong understanding of how data passes through their interfaced systems within the data lifecycle. Expert facilitation from WakeUp to Quality and active collaboration with your staff will allow us capture your process map and the regulated data flows within that process, giving you confidence that your data can be trusted throughout.
Quality Management Systems
WakeUp to Quality can work with you to build a tailored QMS focused on maintaining quality for your computerized systems thus ensuring compliance to GxP regulations. The QMS will include governance, policies, metrics and SOPs to give you confidence and assurance ongoing.
Training
Onsite, virtual or hybrid training is available covering a wide range of topics within computerized systems validation, data integrity, and quality. Tell us your needs!