Consultancy Services
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?
Computerized Systems Quality Audits based on Annex 11 and GAMP
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.
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.
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!