Acumen Software Change Log
Template Updates
| Date | Module | Template | Change |
| 10-May-21 | M1 UK | IMPD Full | IMPD Full Added IMPD full template |
| 10-May-21 | M3 Templates | 3.2.R Regional Information_Placeholder.docx | Updated guidance. Module updated to align more closely to guidance here: https://www.fda.gov/files/drugs/published/M4-Organization-of-the-Common-Technical-Document-for-the-Registration-of-Pharmaceuticals-for-Human-Use-Guidance-for-Industry.pdf |
| 10-May-21 | M3 Templates | 3.2.S.6 Container Closure System.docx | Updated guidance. Module updated to align more closely to guidance here: https://www.fda.gov/files/drugs/published/M4-Organization-of-the-Common-Technical-Document-for-the-Registration-of-Pharmaceuticals-for-Human-Use-Guidance-for-Industry.pdf |
| 10-May-21 | M3 Templates | 3.2.S.5 Reference Standards or Materials.docx | Updated guidance. Module updated to align more closely to guidance here: https://www.fda.gov/files/drugs/published/M4-Organization-of-the-Common-Technical-Document-for-the-Registration-of-Pharmaceuticals-for-Human-Use-Guidance-for-Industry.pdf |
| 10-May-21 | M3 Templates | 3.2.S.4.5 Justification of Specification.docx | Updated guidance. Module updated to align more closely to guidance here: https://www.fda.gov/files/drugs/published/M4-Organization-of-the-Common-Technical-Document-for-the-Registration-of-Pharmaceuticals-for-Human-Use-Guidance-for-Industry.pdf |
| 10-May-21 | M3 Templates | 3.2.S.4.4 Batch Analyses.docx | Updated guidance. Module updated to align more closely to guidance here: https://www.fda.gov/files/drugs/published/M4-Organization-of-the-Common-Technical-Document-for-the-Registration-of-Pharmaceuticals-for-Human-Use-Guidance-for-Industry.pdf |
| 10-May-21 | M3 Templates | 3.2.S.4.3 Validation of Analytical Procedures.docx | Updated guidance. Module updated to align more closely to guidance here: https://www.fda.gov/files/drugs/published/M4-Organization-of-the-Common-Technical-Document-for-the-Registration-of-Pharmaceuticals-for-Human-Use-Guidance-for-Industry.pdf |
| 10-May-21 | M3 Templates | 3.2.A.2 Adventitious Agents Safety Evaluation.docx | Updated guidance. Module updated to align more closely to guidance here: https://www.fda.gov/files/drugs/published/M4-Organization-of-the-Common-Technical-Document-for-the-Registration-of-Pharmaceuticals-for-Human-Use-Guidance-for-Industry.pdf |
| 10-May-21 | M3 Templates | 3.2.A.3 Excipients.docx | Updated guidance. Module updated to align more closely to guidance here: https://www.fda.gov/files/drugs/published/M4-Organization-of-the-Common-Technical-Document-for-the-Registration-of-Pharmaceuticals-for-Human-Use-Guidance-for-Industry.pdf |
| 10-May-21 | M3 Templates | 3.2.A.1 Facilities and Equipment.docx | Updated guidance. Module updated to align more closely to guidance here: https://www.fda.gov/files/drugs/published/M4-Organization-of-the-Common-Technical-Document-for-the-Registration-of-Pharmaceuticals-for-Human-Use-Guidance-for-Industry.pdf |
| 10-May-21 | M3 Templates | 3.2.S.4.1 Specification.docx | Updated guidance. Module updated to align more closely to guidance here: https://www.fda.gov/files/drugs/published/M4-Organization-of-the-Common-Technical-Document-for-the-Registration-of-Pharmaceuticals-for-Human-Use-Guidance-for-Industry.pdf |
| 10-May-21 | M3 Templates | 3.2.P.1 Description and Composition of the Drug Product Non-granular.docx | Updated guidance. Module updated to align more closely to guidance here: https://www.fda.gov/files/drugs/published/M4-Organization-of-the-Common-Technical-Document-for-the-Registration-of-Pharmaceuticals-for-Human-Use-Guidance-for-Industry.pdf |
| 10-May-21 | M3 Templates | 3.2.P.2 Pharmaceutical Development Non-granular.docx | Updated guidance. Module updated to align more closely to guidance here: https://www.fda.gov/files/drugs/published/M4-Organization-of-the-Common-Technical-Document-for-the-Registration-of-Pharmaceuticals-for-Human-Use-Guidance-for-Industry.pdf |
| 10-May-21 | M3 Templates | 3.2.P.3.1 Manufacturers.docx | Updated guidance. Module updated to align more closely to guidance here: https://www.fda.gov/files/drugs/published/M4-Organization-of-the-Common-Technical-Document-for-the-Registration-of-Pharmaceuticals-for-Human-Use-Guidance-for-Industry.pdf |
| 10-May-21 | M3 Templates | 3.2.P.3.2 Batch Formula.docx | Updated guidance. Module updated to align more closely to guidance here: https://www.fda.gov/files/drugs/published/M4-Organization-of-the-Common-Technical-Document-for-the-Registration-of-Pharmaceuticals-for-Human-Use-Guidance-for-Industry.pdf |
| 10-May-21 | M3 Templates | 3.2.P.3.3 Description of Manufacturing Process and Process Controls Non-granular.docx | Updated guidance. Module updated to align more closely to guidance here: https://www.fda.gov/files/drugs/published/M4-Organization-of-the-Common-Technical-Document-for-the-Registration-of-Pharmaceuticals-for-Human-Use-Guidance-for-Industry.pdf |
| 10-May-21 | M3 Templates | 3.2.P.3.4 Controls of Critical Steps and Intermediates.docx | Updated guidance. Module updated to align more closely to guidance here: https://www.fda.gov/files/drugs/published/M4-Organization-of-the-Common-Technical-Document-for-the-Registration-of-Pharmaceuticals-for-Human-Use-Guidance-for-Industry.pdf |
| 10-May-21 | M3 Templates | 3.2.P.3.5 Process Validation and-or Evaluation.docx | Updated guidance. Module updated to align more closely to guidance here: https://www.fda.gov/files/drugs/published/M4-Organization-of-the-Common-Technical-Document-for-the-Registration-of-Pharmaceuticals-for-Human-Use-Guidance-for-Industry.pdf |
| 10-May-21 | M3 Templates | 3.2.P.4.1 Specifications Non-granular.docx | Updated guidance. Module updated to align more closely to guidance here: https://www.fda.gov/files/drugs/published/M4-Organization-of-the-Common-Technical-Document-for-the-Registration-of-Pharmaceuticals-for-Human-Use-Guidance-for-Industry.pdf |
| 10-May-21 | M3 Templates | 3.2.P.4.2 Analytical Procedures.docx | Updated guidance. Module updated to align more closely to guidance here: https://www.fda.gov/files/drugs/published/M4-Organization-of-the-Common-Technical-Document-for-the-Registration-of-Pharmaceuticals-for-Human-Use-Guidance-for-Industry.pdf |
| 10-May-21 | M3 Templates | 3.2.P.4.3 Validation of Analytical Procedures.docx | Updated guidance. Module updated to align more closely to guidance here: https://www.fda.gov/files/drugs/published/M4-Organization-of-the-Common-Technical-Document-for-the-Registration-of-Pharmaceuticals-for-Human-Use-Guidance-for-Industry.pdf |
| 10-May-21 | M3 Templates | 3.2.P.4.4 Justification of Specifications.docx | Updated guidance. Module updated to align more closely to guidance here: https://www.fda.gov/files/drugs/published/M4-Organization-of-the-Common-Technical-Document-for-the-Registration-of-Pharmaceuticals-for-Human-Use-Guidance-for-Industry.pdf |
| 10-May-21 | M3 Templates | 3.2.P.4.5 Excipients of Human or Animal Origin.docx | Updated guidance. Module updated to align more closely to guidance here: https://www.fda.gov/files/drugs/published/M4-Organization-of-the-Common-Technical-Document-for-the-Registration-of-Pharmaceuticals-for-Human-Use-Guidance-for-Industry.pdf |
| 10-May-21 | M3 Templates | 3.2.P.4.6 Novel Excipients.docx | Updated guidance. Module updated to align more closely to guidance here: https://www.fda.gov/files/drugs/published/M4-Organization-of-the-Common-Technical-Document-for-the-Registration-of-Pharmaceuticals-for-Human-Use-Guidance-for-Industry.pdf |
| 10-May-21 | M3 Templates | 3.2.P.5.1 Specifications.docx | Updated guidance. Module updated to align more closely to guidance here: https://www.fda.gov/files/drugs/published/M4-Organization-of-the-Common-Technical-Document-for-the-Registration-of-Pharmaceuticals-for-Human-Use-Guidance-for-Industry.pdf |
| 10-May-21 | M3 Templates | 3.2.P.5.2 Analytical Procedures.docx | Updated guidance. Module updated to align more closely to guidance here: https://www.fda.gov/files/drugs/published/M4-Organization-of-the-Common-Technical-Document-for-the-Registration-of-Pharmaceuticals-for-Human-Use-Guidance-for-Industry.pdf |
| 10-May-21 | M3 Templates | 3.2.P.5.3 Validation of Analytical Procedures.docx | Updated guidance. Module updated to align more closely to guidance here: https://www.fda.gov/files/drugs/published/M4-Organization-of-the-Common-Technical-Document-for-the-Registration-of-Pharmaceuticals-for-Human-Use-Guidance-for-Industry.pdf |
| 10-May-21 | M3 Templates | 3.2.P.5.4 Batch Analyses Non-granular.docx | Updated guidance. Module updated to align more closely to guidance here: https://www.fda.gov/files/drugs/published/M4-Organization-of-the-Common-Technical-Document-for-the-Registration-of-Pharmaceuticals-for-Human-Use-Guidance-for-Industry.pdf |
| 10-May-21 | M3 Templates | 3.2.P.5.5 Characterization of Impurities.docx | Updated guidance. Module updated to align more closely to guidance here: https://www.fda.gov/files/drugs/published/M4-Organization-of-the-Common-Technical-Document-for-the-Registration-of-Pharmaceuticals-for-Human-Use-Guidance-for-Industry.pdf |
| 10-May-21 | M3 Templates | 3.2.P.5.6 Justification of Specifications.docx | Updated guidance. Module updated to align more closely to guidance here: https://www.fda.gov/files/drugs/published/M4-Organization-of-the-Common-Technical-Document-for-the-Registration-of-Pharmaceuticals-for-Human-Use-Guidance-for-Industry.pdf |
| 10-May-21 | M3 Templates | 3.2.P.6 Reference Standards or Materials.docx | Updated guidance. Module updated to align more closely to guidance here: https://www.fda.gov/files/drugs/published/M4-Organization-of-the-Common-Technical-Document-for-the-Registration-of-Pharmaceuticals-for-Human-Use-Guidance-for-Industry.pdf |
| 10-May-21 | M3 Templates | 3.2.P.8.2 Postapproval Stability Protocol and Stability Commitment.docx | Updated guidance. Module updated to align more closely to guidance here: https://www.fda.gov/files/drugs/published/M4-Organization-of-the-Common-Technical-Document-for-the-Registration-of-Pharmaceuticals-for-Human-Use-Guidance-for-Industry.pdf |
| 10-May-21 | M3 Templates | 3.2.P.8.1 Stability Summary and Conclusion Non-granular.docx | Updated guidance. Module updated to align more closely to guidance here: https://www.fda.gov/files/drugs/published/M4-Organization-of-the-Common-Technical-Document-for-the-Registration-of-Pharmaceuticals-for-Human-Use-Guidance-for-Industry.pdf |
| 10-May-21 | M3 Templates | 3.2.P.8.3 Stability Data Non-granular.docx | Updated guidance. Module updated to align more closely to guidance here: https://www.fda.gov/files/drugs/published/M4-Organization-of-the-Common-Technical-Document-for-the-Registration-of-Pharmaceuticals-for-Human-Use-Guidance-for-Industry.pdf |
| 10-May-21 | M3 Templates | 3.2.S.7.1 Stability Summary and Conclusions Non-granular.docx | Updated guidance. Module updated to align more closely to guidance here: https://www.fda.gov/files/drugs/published/M4-Organization-of-the-Common-Technical-Document-for-the-Registration-of-Pharmaceuticals-for-Human-Use-Guidance-for-Industry.pdf |
| 10-May-21 | M3 Templates | 3.2.S.7.2 Post-approval Stability Protocol and Stability Commitment.docx | Updated guidance. Module updated to align more closely to guidance here: https://www.fda.gov/files/drugs/published/M4-Organization-of-the-Common-Technical-Document-for-the-Registration-of-Pharmaceuticals-for-Human-Use-Guidance-for-Industry.pdf |
| 10-May-21 | M3 Templates | 3.2.S.7.3 Stability Data Non-granular.docx | Updated guidance. Module updated to align more closely to guidance here: https://www.fda.gov/files/drugs/published/M4-Organization-of-the-Common-Technical-Document-for-the-Registration-of-Pharmaceuticals-for-Human-Use-Guidance-for-Industry.pdf |
| 10-May-21 | M3 Templates | 3.2.S.2.1 Manufacturers.docx | Updated guidance. Module updated to align more closely to guidance here: https://www.fda.gov/files/drugs/published/M4-Organization-of-the-Common-Technical-Document-for-the-Registration-of-Pharmaceuticals-for-Human-Use-Guidance-for-Industry.pdf |
| 10-May-21 | M3 Templates | 3.2.S.2.2 Description of Manufacturing Process and Process Controls Non-granular.docx | Updated guidance. Module updated to align more closely to guidance here: https://www.fda.gov/files/drugs/published/M4-Organization-of-the-Common-Technical-Document-for-the-Registration-of-Pharmaceuticals-for-Human-Use-Guidance-for-Industry.pdf |
| 10-May-21 | M3 Templates | 3.2.S.2.3 Control of Materials Non-granular.docx | Updated guidance. Module updated to align more closely to guidance here: https://www.fda.gov/files/drugs/published/M4-Organization-of-the-Common-Technical-Document-for-the-Registration-of-Pharmaceuticals-for-Human-Use-Guidance-for-Industry.pdf |
| 10-May-21 | M3 Templates | 3.2.S.2.4 Control of Critical Steps and Intermediates Non-granular.docx | Updated guidance. Module updated to align more closely to guidance here: https://www.fda.gov/files/drugs/published/M4-Organization-of-the-Common-Technical-Document-for-the-Registration-of-Pharmaceuticals-for-Human-Use-Guidance-for-Industry.pdf |
| 10-May-21 | M3 Templates | 3.2.S.2.5 Process Validation and-or Evaluation.docx | Updated guidance. Module updated to align more closely to guidance here: https://www.fda.gov/files/drugs/published/M4-Organization-of-the-Common-Technical-Document-for-the-Registration-of-Pharmaceuticals-for-Human-Use-Guidance-for-Industry.pdf |
| 10-May-21 | M3 Templates | 3.2.S.2.6 Manufacturing Process Development.docx | Updated guidance. Module updated to align more closely to guidance here: https://www.fda.gov/files/drugs/published/M4-Organization-of-the-Common-Technical-Document-for-the-Registration-of-Pharmaceuticals-for-Human-Use-Guidance-for-Industry.pdf |
| 10-May-21 | M3 Templates | 3.2.S.3.1 Elucidation of Structure and Other Characteristics.docx | Updated guidance. Module updated to align more closely to guidance here: https://www.fda.gov/files/drugs/published/M4-Organization-of-the-Common-Technical-Document-for-the-Registration-of-Pharmaceuticals-for-Human-Use-Guidance-for-Industry.pdf |
| 10-May-21 | M3 Templates | 3.2.S.3.2 Impurities Non-granular.docx | Updated guidance. Module updated to align more closely to guidance here: https://www.fda.gov/files/drugs/published/M4-Organization-of-the-Common-Technical-Document-for-the-Registration-of-Pharmaceuticals-for-Human-Use-Guidance-for-Industry.pdf |
| 10-May-21 | M3 Templates | 3.2.S.4.2 Analytical Procedures.docx | Updated guidance. Module updated to align more closely to guidance here: https://www.fda.gov/files/drugs/published/M4-Organization-of-the-Common-Technical-Document-for-the-Registration-of-Pharmaceuticals-for-Human-Use-Guidance-for-Industry.pdf |
| 10-May-21 | M3 Templates | 3.2.P.7 Container Closure System [name, dosage form].docx | Updated guidance. Module updated to align more closely to guidance here: https://www.fda.gov/files/drugs/published/M4-Organization-of-the-Common-Technical-Document-for-the-Registration-of-Pharmaceuticals-for-Human-Use-Guidance-for-Industry.pdf |
| 10-May-21 | M3 Templates | 3.2.S.1 General Information [name, manufacturer].docx | Updated guidance. Module updated to align more closely to guidance here: https://www.fda.gov/files/drugs/published/M4-Organization-of-the-Common-Technical-Document-for-the-Registration-of-Pharmaceuticals-for-Human-Use-Guidance-for-Industry.pdf |
| 16-Nov-21 | M5 Templates | ICF - Informed Consent Form | Added |
| 14-Sep-21 | M1 Templates | Top Line Data | Added |
| 28-Sep-21 | M1 Templates | PLR Template | |
| 6-Feb-23 | M1 Templates | 1.6.2 Pre-IND Meeting Background Materials | Updated guiance and structure. |
| 29-Mar-22 | M2 Templates | 2.6.1 Introduction | Added/updated headings |
| 1-Dec-22 | M1 Templates | 1.14.4.1 IB | Updated guidance |
| 8-Dec-22 | M1 Templates | 1.14.4.1 IB Addendum | New addition |
| 13-Jun-23 | M5 Templates | PADER | New addition |
| 13-Jun-23 | M5 Templates | PSUR | New addition |
| 3-Jul-23 | M1 Templates | DSUR | Updated to add tips |
| 1-Aug-23 | M1 Templates | 1.14.4.1 IB Addendum | Updated footer and header |
| 3-Nov-23 | M5 Templates | ICF - Informed Consent Form | Updated with new guidance |
| 4-Jan-24 | M3 Templates | Facilities and Equipment.docx | Updated with new guidance and tips |
| 4-Jan-24 | M3 Templates | Adventitious Agents Safety Evaluation.docx | Updated with new guidance and tips |
| 4-Jan-24 | M3 Templates | Excipients.docx | Updated with new guidance and tips |
| 4-Jan-24 | M3 Templates | Description and Composition of the Drug Product Non-granular.docx | Updated with new guidance and tips |
| 4-Jan-24 | M3 Templates | Pharmaceutical Development Non-granular.docx | Updated with new guidance and tips |
| 4-Jan-24 | M3 Templates | Components of the Drug Product non-granular.docx | Updated with new guidance and tips |
| 4-Jan-24 | M3 Templates | Drug Product Non-granular.docx | Updated with new guidance and tips |
| 4-Jan-24 | M3 Templates | Manufacturing Process Development.docx | Updated with new guidance and tips |
| 4-Jan-24 | M3 Templates | Container Closure System.docx | Updated with new guidance and tips |
| 4-Jan-24 | M3 Templates | Microbiological Attributes.docx | Updated with new guidance and tips |
| 4-Jan-24 | M3 Templates | Compatibility.docx | Updated with new guidance and tips |
| 4-Jan-24 | M3 Templates | Manufactureres.docx | Updated with new guidance and tips |
| 4-Jan-24 | M3 Templates | Batch Formula.docx | Updated with new guidance and tips |
| 4-Jan-24 | M3 Templates | Description of Manufacturing Process and Process Controls Non-granular.docx | Updated with new guidance and tips |
| 4-Jan-24 | M3 Templates | Controls of Critical Steps and Intermediates.docx | Updated with new guidance and tips |
| 4-Jan-24 | M3 Templates | Process Validation and-or Evaluation.docx | Updated with new guidance and tips |
| 4-Jan-24 | M3 Templates | Specifications Non-granular.docx | Updated with new guidance and tips |
| 4-Jan-24 | M3 Templates | Analytical Procedures-Test Method.docx | Updated with new guidance and tips |
| 4-Jan-24 | M3 Templates | Analytical Procedures.docx | Updated with new guidance and tips |
| 4-Jan-24 | M3 Templates | Validation of Analytical Procedures.docx | Updated with new guidance and tips |
| 4-Jan-24 | M3 Templates | Justification of Specifications.docx | Updated with new guidance and tips |
| 4-Jan-24 | M3 Templates | Excipients of Human or Animal Origin.docx | Updated with new guidance and tips |
| 4-Jan-24 | M3 Templates | Novel Excipients.docx | Updated with new guidance and tips |
| 4-Jan-24 | M3 Templates | Specifications.docx | Updated with new guidance and tips |
| 4-Jan-24 | M3 Templates | Analytical Procedures-Test Method.docx | Updated with new guidance and tips |
| 4-Jan-24 | M3 Templates | Validation of Analytical Procedures-Test Method.docx | Updated with new guidance and tips |
| 4-Jan-24 | M3 Templates | Batch Analyses Non-granular.docx | Updated with new guidance and tips |
| 4-Jan-24 | M3 Templates | Characterization of Impurities.docx | Updated with new guidance and tips |
| 4-Jan-24 | M3 Templates | Justification of Specifications.docx | Updated with new guidance and tips |
| 4-Jan-24 | M3 Templates | ference Standards or Materials.docx | Updated with new guidance and tips |
| 4-Jan-24 | M3 Templates | ntainer Closure System [name, dosage form].docx | Updated with new guidance and tips |
| 4-Jan-24 | M3 Templates | Container Closure System Non-granular.docx | Updated with new guidance and tips |
| 4-Jan-24 | M3 Templates | Stability Summary and Conclusion Non-granular.docx | Updated with new guidance and tips |
| 4-Jan-24 | M3 Templates | Postapproval Stability Protocol and Stability Commitment.docx | Updated with new guidance and tips |
| 4-Jan-24 | M3 Templates | Stability Data Non-granular.docx | Updated with new guidance and tips |
| 4-Jan-24 | M3 Templates | onal Information_Placeholder.docx | Updated with new guidance and tips |
| 4-Jan-24 | M3 Templates | thods Validation Package.docx | Updated with new guidance and tips |
| 4-Jan-24 | M3 Templates | neral Information [name, manufacturer].docx | Updated with new guidance and tips |
| 4-Jan-24 | M3 Templates | Nomenclature.docx | Updated with new guidance and tips |
| 4-Jan-24 | M3 Templates | Structure.docx | Updated with new guidance and tips |
| 4-Jan-24 | M3 Templates | General Properties.docx | Updated with new guidance and tips |
| 4-Jan-24 | M3 Templates | Manufacturers.docx | Updated with new guidance and tips |
| 4-Jan-24 | M3 Templates | Description of Manufacturing Process and Process Controls Non-granular.docx | Updated with new guidance and tips |
| 4-Jan-24 | M3 Templates | Control of Materials Non-granular.docx | Updated with new guidance and tips |
| 4-Jan-24 | M3 Templates | Control of Critical Steps and Intermediates Non-granular.docx | Updated with new guidance and tips |
| 4-Jan-24 | M3 Templates | Process Validation and-or Evaluation.docx | Updated with new guidance and tips |
| 4-Jan-24 | M3 Templates | Manufacturing Process Development.docx | Updated with new guidance and tips |
| 4-Jan-24 | M3 Templates | Elucidation of Structure and Other Characteristics).docx | Updated with new guidance and tips |
| 4-Jan-24 | M3 Templates | Impurities Non-granular.docx | Updated with new guidance and tips |
| 4-Jan-24 | M3 Templates | Specification.docx | Updated with new guidance and tips |
| 4-Jan-24 | M3 Templates | Analytical Procedures-Test Method.docx | Updated with new guidance and tips |
| 4-Jan-24 | M3 Templates | Validation of Analytical Procedures-Test Method.docx | Updated with new guidance and tips |
| 4-Jan-24 | M3 Templates | Batch Analyses .docx | Updated with new guidance and tips |
| 4-Jan-24 | M3 Templates | Justification of Specification.docx | Updated with new guidance and tips |
| 4-Jan-24 | M3 Templates | Conference Standards or Materials.docx | Updated with new guidance and tips |
| 4-Jan-24 | M3 Templates | Container Closure System.docx | Updated with new guidance and tips |
| 4-Jan-24 | M3 Templates | Stability Summary and Conclusions Non-granular.docx | Updated with new guidance and tips |
| 4-Jan-24 | M3 Templates | Post-approval Stability Protocol and Stability Commitment.docx | Updated with new guidance and tips |
| 4-Jan-24 | M3 Templates | Stability Data Non-granular.docx | Updated with new guidance and tips |