Spreadsheet Validation

Data Integrity App   Spreadsheets used in GMP operations must meet data integrity requirements including the principles from ALCOA which requires data to meet the following criteria: ·          Attributable ·          Legible ·          Contemporaneous ·          Original  ·          Accurate Attributable spreadsheet data must be linked to the individual who created the data. Legible spreadsheet data is clear, concise, and readable. Changes to legible data must not hide or obscure the original record. Contemporaneous spreadsheet data is recorded at the time the work is performed.  Original spreadsheet data include the first or source capture of data or information and all subsequent data required to fully reconstruct the conduct of the GXP activity Accurat...

Data Integrity App   The pharmaceutical and biotechnology industry continues to struggle with understanding how to validate and manage the integrity of data generated by spreadsheets. One of the biggest challenges is the fact that companies normally don’t have an inventory of spreadsheets used for GMP operations. The lack of an inventory is a key indicator of the lack of knowledge of the number of spreadsheet that require validation and that must meet data integrity requirements. This create a significant compliance and business risk because companies normally have spreadsheets that are not in a state of control and that don’t meet regulatory expectations related to validation and data integrity. Another challenge is the fact that those legacy spreadsheets are not properly configured to enable functions that provide alignment with data integrity requirements. Legacy spreadsheets that are not properly configured to enable data integrity and often lack adequate logical securi...

Data Integrity App   Spreadsheets are widely used in the industry in Quality Control and manufacturing areas Many GxP critical spreadsheets need to undergo validation to ensure that the data they generate is accurate and secure. One of the biggest challenges the industry faced for years is how to validate, maintain, and manage the integrity of data generated using spreadsheets in GMP areas. Spreadsheets used in GMP areas must be validated and meet data integrity requirements applicable to the industry. Data integrity of spreadsheets is extremely important because they often generate critical GMP data that have an impact on the product Critical Quality Attributes. The lack of data integrity in spreadsheets can have a negative impact on the product quality and safety because they are often used to manipulate data generated in the quality control laboratories that is related to testing product quality attributes. Here we describe a pragmatic approach to the validation of E...