Excel Spreadsheets are most familiar and offers complete ‘Flexibility’ for the Compilation of Daily Expenses to calculation of Complex Mathematical Calculations.
Typical Pharmaceutical Companies use it for calculation of Assay, Impurities or Content Determination along with Different Method Validation experiments, Pharmacokinetic Data compilations, Biological Data Equivalency Studies etc.
In recent days, “these have become the primary focus of auditors at each step during verification of data” and, Excel Sheet validation has become mandatory in all organizations that regularly deal with different regulatory authorities and higher customer audits. A validated Excel sheet creates higher confidence and greater impression to any auditor rather than the regular use Excel spread sheet as the process of validation increases trust, confidence and the data security.
Alternatively, Many Analytical CDS software’s provide a very special inbuilt & extended feature called "CUSTOM CALCULATIONS" where users can customize the mathematical calculations and formulae using defined custom fields and formulae via different statistical tools.
These offer higher confidence rather than a Validated Excel sheet because…
To meet the ever increasing challenges of regulatory compliance and laboratory efficiency
- Traceability of Chromatographic Data Vs Calculations & Results increases
- Risk of losing excel spreadsheet data reduced since CDS software’s provide higher security during backup
- At a tiresults and calculations can be available against the particular chromatogramme both
- The software’s also help in Reporting Template creation
- The software’s are generally 21CFR Compliant comes and comes under validated software’s
- With simple verification approach, the created formulae can be verified or
- With a detailed Validation approach, the created formulae can be validated
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CURRENT SCENARIO – DIFFERENT PROCESSES IN LAB
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CURRENT SCENARIO – TIME TAKEN FOR EACH PROCESS
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ADVANTAGES WITH CUSTOM CALCULATIONS AND IMPROVED SCENARIO
All Popular CDS lke Empower Software by Waters, Chromeleon by Thermo and Lab Solutions by Agilent etc.. provide the feature as inbuilt and Customization of the same needs some a systematic process of training the team, dedicated people working on the customization as per inhouse requirements and monitoring the implementation.
Simpruv has a unique capability of supporting both in Excel Spreadsheet Validation and Training on Custom Calculations in major CDS software’s. This gives additional advantage where users can choose the type of activity based on their facility requirements.
Simpruv core SME has completed successful implementation of Custom Calculations in all Major Pharmaceutical Companies like Pfizer, Dr Reddys, Hetero, MSN Laboratories and many organizations over all India and can take care of all your requirements in a reliable, phase wise and systematic approach.
For a more detailed understanding, refer the next pages
Advantages of Custom Calculations in Revenue and Compliance Improvement, Cost Reduction:
In most of the QC and R&D Labs, once the analysis is completed. Data will be taken as printout and the results are calculated based on the formulae. Once this completes, the results are summarized. COA is prepared and shared to the Approver.
Depending on the requirement, every organization scrutinizes the data along with the calculations at many steps like Manager / Lab approver, QA approver and then finally COA/batches are released.
Also during the Audits and inspections also the amount of time spent by each auditor is more than 2-3 days to verify the same. Especially if the excel sheets are not validated, it may take still more time.
Overall, the approval process consumes 4-5 days and audit consumes 2-3 days when using Excel Spreadsheets.
But when custom calculations are involved, the whole cycle time reduces since, the data is fool proof and all calculations related to data are also embedded inside and any changes done are also easily tracked. This reduces the total batch release to less than a day and finally during Audit, the data can be verified in less than < 1 day. In case of Method Validation, the benefits are still higher.