CGMP Academy is now launching consulting services. We advise clients on the following topic areas:
Validation
By definition, Validation is a program that provides a high degree of assurance that produces a result meeting pre-determined acceptance criteria consistently for methods, systems, equipment, and processes. As a result, we help clients align with industry best practices (along with regulatory requirements) to ensure adequate documentation and verification regarding their methods, systems, equipment, and processes. We also advocate for validation program enablers like the following:
- Risk-based approach for validation projects
- Utilizing Good Engineering Practices to support specification, design and verification activities including development of S.M.A.R.T. requirements (Specific, Measurable, Acheivable, Realistic, Testable)
- Risk Assessments for determining the extent verification, analysis of risks related to intended use, and compliance with regulatory requirements (e.g. 21 CFR Part 111, data integrity risks, audit trail review etc.)
Since validation applies to processes, cleaning, procedures, methods, equipment, and systems, we are highly savvy in commissioning and qualification of equipment & laboratory instrumentation, and computerized systems validation.
Computerized Systems Validation
Validating computerized systems presents many challenges for regulated manufacturers especially for projects involving highly automated laboratory instrumentation, calculation spreadsheets, or enterprise databases. We help to alleviate those challenges by providing insights into the Computerized System Validation program or a particular computerized system validation project. A few industry best practices (including ISPE GAMP® 52) we advocate for include the following
- Categorization of software & hardware
- Functional Risk Assessments to determine the extent of verification and operational use related risks (including data integrity risks)
- Configuration Management & Change Management
- Procedures for use such as operation & maintenance, administration & access, data & record management, periodic review, and configuration management
Commissioning & Qualification of Equipment and Instrumentation
Coupled with our knowledge of computerized systems is expertise regarding commissioning and qualification of equipment and instrumentation. From simple equipment and devices to fully automated liquid handlers (e.g. Tecan or Hamilton), we can handle projects of varying degrees of complexity.
Data Integrity
The degree to which data are complete, consistent, and accurate throughout the data lifecycle is the definition of Data Integrity. Equally important is Data Governance, the arrangements to ensure that data, irrespective of the format in which information is generated, recorded, processed, retained, and used to ensure the record throughout the data lifecycle3. However, determining the extent to which data is complete, consistent, accurate throughout various processes, workstreams, and systems can be extremely challenging for manufacturers to understand and implement adequate controls. As a result, we can provide an array of tools to empower organizations to better identify and understand their data integrity risks such as Data Integrity Risk Assessments (DIRA) and data process flows. Additionally, we educate organizations on how to best implement controls to reduce their data integrity risks. Let us help you implement and/or mature your data governance program or get a data integrity project launched.
Articles
References
121 CFR Part 11 – Electronic Records; Electronic Signatures, Code of Federal Regulations, US Food and Drug Administration (FDA), www.fda.gov
2ISPE GAMP® 5: A Risk-Based Approach to Compliant GxP Computerized Systems, International Society for Pharmaceutical Engineering (ISPE), Fifth Edition, February 2008, www.ispe.org
3MHRA GXP Data Integrity Definitions and Guidance for Industry, Revision 1., March 2018, https://www.gov.uk/government/publications/guidance-on-gxp-data-integrity