The Certificate of Analysis/Conformity is a GMP-critical document and must satisfy traceability requirements to ensure data security and consistency. In addition to regulatory requirements and guidelines, pharmaceutical companies must comply with customers’ requirements (for example, the list of tests to be displayed in the certificate may vary from customer to customer).
Certificate of Analysis/Conformity (SSRS report)
Life Sciences Quality Control & Assurance offers functionalities to manage the creation and printing of Certificates of Analysis/Conformity by item, customer, country, manufacturing site, and analysis type.
The Override CoA layout parameter in the Life Sciences Quality Control & Assurance parameters form (Life Sciences Quality Control & Assurance > Setup > Life Sciences Quality Control & Assurance parameters) allows authorized users to specify whether the default Certificate of Analysis layout can be overridden when generating certificates from quality orders. Enabling this option allows users to print the Life Sciences customized report layout for Certificates of Analysis.
Certificates of Analysis/Conformity can be created from quality orders by clicking Inquiries > Certificate of analysis. The Certificate of analysis form is opened, and authorized users can create a new certificate by clicking New. The Certificate of analysis, Quality order reference, Item number, and the Created date and time fields are automatically populated. The Time point, Sampling point, and Storage condition fields are automatically populated for quality orders related to stability study and/or environmental control.
Life Sciences Quality Control & Assurance adds the following fields to the Certificate of analysis form:
Certificate type: used to choose whether a “Certificate of Analysis” or “Certificate of Conformity” layout should be printed;
Country/region: If there is a test statement for the selected customer/item/country combination, the text of the statement will be printed on the certificate.
Sales order: reference to the sales order used to ship the material to the customer. The order information (delivery address, order number) is printed in the LS report layouts;
Customer reference: if a sales order is selected, displays the related Customer reference (non-editable) and prints it in the report (Your PO number field).
Packing slip: If a packing slip is selected, the shipped quantity is displayed in the certificate;
Override shipped quantity: overrides the printed shipping quantity, if different from the one defined in the sales order;
Analysis type: when a value is selected, only the quality order lines associated with the selected analysis type are printed on the report;
Packing slip: if a sales order is selected, allows the selection of a packing slip. When selected, the packing slip quantity will be printed as Shipped quantity in the CoA/CoC report.
Time point, Storage condition, Sampling point: inherited from the selected quality order and non-editable.
Note
Some fields may be unavailable if the Override CoA layout parameter is disabled.
The report is generated by clicking the Print button.
Certificate of Analysis/Conformity (electronic report)
The layout and information printed on the Certificate of Analysis and Certificate of Conformity may vary from company to company or may depend on the destination country where the finished product needs to be marketed. For this reason, the ERP must allow certificate management in a flexible way and the definition of multiple layouts (e.g., depending on the market).
Life Sciences Supply Chain Management adds the possibility to generate the Certificate of Analysis and Certificate of Conformity reports via the Standard D365 Electronic reporting feature. This tool allows business users to manage reports in a configurable and flexible way.
The report templates are configured as a format based on data model configuration (Organization administration > Workspaces > Electronic reporting > Reporting configurations) associated with the “AQMCoA” tag for the Certificate of Analysis and “AQMCoC” tag for the Certificate of Conformity. For details on how to configure electronic reporting from scratch, please refer to Microsoft material.
Leveraging the Microsoft Electronic reporting tool, it is possible to define multi-language reports for the Certificate of Analysis and Certificate of Conformity.
Certificates of Analysis/Conformity can be created from quality orders by clicking Inquiries > Certificate of analysis. The Certificate of analysis form is opened, and authorized users can create a new certificate by clicking New and defining the type of certificate in the Certificate type field (Analysis or Conformity). Other information can be entered as described for the SSRS reports above.
The report is generated by clicking the Generate certificate button. The user is prompted to select the format to be used to print the document.
Note
If the Certificate type is “Certificate of Analysis”, only the formats associated with the “AQMCoA” tag are displayed in the dropdown. If the Certificate type is “Certificate of Conformity”, only the formats associated with the “AQMCoC” tag are displayed in the dropdown.
In the case of a reprint, the user is not asked to select the format; the system reprints the same document previously generated.
Prints and reprints of the Certificate of Analysis ER report are tracked in the Electronic reporting archived jobs form (Organization administration > Electronic reporting > Electronic reporting archived jobs).