Applications · Laboratory
Calculation sheets
Most labs with a LIMS and a CDS still keep validated Excel sheets. Quickflow eSheet replaces them with validated web forms: constants come from master data, peak areas from the CDS and every entry is checked as it is typed. A Digital Scientist builds each sheet from the method and makes the case when a result falls out of trend. The reviewer signs online.
One assay result · Metformin HCl Tablets 500 mg, batch MT-118
Quickflow eSheet · New calculation sheet
Test
Assay by HPLC
Product
Metformin HCl Tablets 500 mg
Batch
MT-118
T-ASSAY-HPLC · v3
- Validated · approved
- Formula locked
- Limits set per product
Step 1 of 8Analyst · Priya Shah
The analyst opens the assay template for the batch
Priya picks the test, the product and the batch. There is one validated assay template for every product; the product’s master data decides the limits, dilutions and factors, so no one copies last month’s workbook.
Quickflow eSheet at a glance
Validated web calculation sheets that replace Excel in the QC and AR&D lab.
- Who uses it
- QC analysts
- Reviewers
- Lab managers
- AR&D teams
- What is included
- One template, every product
- Values from their source
- Checks as you type
- OOS and OOT recalculation
- Online review and e-signature
- Batch history and trending
- Works with
- LIMS
- Empower and other CDS
- Balances
- Master data
- Built for
- 21 CFR Part 11
- EU Annex 11
- GAMP 5 category 4
How it works
5 steps. Every one recorded.
- Step 1Select templateSystem
- Step 2Fields pre-populatedSystem
- Step 3Values from instrumentsSystem
- Step 4Auto-calculateSystem
- Step 5Review and e-signHuman decision
The question every QA head asks
We have a LIMS and Empower. Why is Excel still everywhere?
Because one reportable result needs values from five places, and the spreadsheet is where someone types them together.
- LIMSSpecification, average weight
- EmpowerPeak areas
- Balance printoutWeights
- Standard certificatePurity
- Last batch’s workbookFormula, dilutions
Assay_MT118_v7_FINAL(2).xlsx
Typed by hand: 0| 2 | Specification | |
| 3 | Avg weight (mg) | |
| 4 | Std area | |
| 5 | Sample area | |
| 6 | Std weight (mg) | |
| 7 | Sample weight (mg) | |
| 8 | Purity (%) | |
| 9 | Assay (% LC) |
- Printed, signed, scanned
- Result retyped into the LIMS
Illustrative workbook with placeholder values.
Already in the lab
LIMS
Sample lifecycle, specifications, routine release calculations, approvals
A LIMS runs the standard release calculations set up per product and specification. Anything outside that configuration has nowhere to run.
Example: Relative response factors for six impurities, a water-content correction and a potency-as-is conversion in one result.
Already in the lab
Empower and Chromeleon
Acquisition, integration, areas, amounts, custom fields, CDS audit trail
Empower gives areas, amounts and custom-field results. The reportable result still needs sample weights, dilutions, standard purity and water content from outside the CDS.
Example: Assay result = area ratio × standard purity × dilution factor ÷ sample weight, corrected for LOD.
Excel lives here
Complex calculations
Multi-step results that combine CDS output with weights, purities, dilutions and corrections.
- Related substances with RRF
- Assay corrected for water and LOD
- Content uniformity acceptance value
- Dissolution f2 similarity
Excel lives here
OOS and OOT investigations
Hypothesis testing, recalculation and trending outside the locked release workflow.
- Phase I laboratory investigation
- Retest and resample averaging
- Batch-to-batch trending
- Alternative integration impact
Excel lives here
Method validation and transfer
One-off studies with statistics the LIMS does not offer.
- Linearity, accuracy, precision, range
- Intermediate precision ANOVA
- Robustness
- Sending vs receiving site equivalence
And it stays because 01
Validated templates already exist
SOPs reference them, analysts know them, and revalidating in another tool feels like extra work.
And it stays because 02
Excel is free and instant
No licence, no vendor ticket, no change control to start. The cost appears later, at inspection.
And it stays because 03
Reports need formatting
Regulatory-style tables, stability graphs and transfer reports are easier to shape in a spreadsheet than a LIMS report designer.
And it stays because 04
Rounding and reporting rules
Significant figures, reporting thresholds and rounding conventions differ by pharmacopoeia and by customer. Spreadsheets bend; systems do not.
What an inspector sees
Six ways a validated spreadsheet becomes a 483 observation
The same assay workbook, six times. Pick a risk area, or let them play.
| 2 | Std area | 1254280 |
| 3 | Sample area | 1249870 |
| 4 | Std weight (mg) | 50.12 |
| 5 | Sample weight (mg) | 623.4 |
| 6 | Purity (%) | 99.8 |
| 7 | Assay (% LC) | 99.6 |
B7 holds the validated formula.
Typical findings · Data integrity
- Formulas or calculations altered to yield favourable results
- Changes made without documentation; previous versions not preserved
- No reliable backup or recovery of critical sheets
- Unauthorised users able to modify or delete data
The hidden effort
Six chores, every product, every change
Three products and four tests already make twelve workbooks. Each one goes round this loop, and goes round again when a specification changes.
- Build a sheet per productOne workbook per product, dosage form and test, each copied from the last and modified.
- 2Validate each one
- 3Retype the constants
- 4Disable macros and formulas
- 5Protect and police copies
- 6Re-enter on any discrepancy
12 workbooks · QC shared drive
Step 1 of 6 · Build a sheet per productBefore and after
Validated Excel, then Quickflow eSheet
The same assay result, twice. One goes round a printed workbook and a reviewer’s tray. The other is checked while it is entered and reaches the LIMS without being typed again.
Today, in Excel
Blank sheet printed: Printing the controlled copy
With Quickflow eSheet
Template opened: One template for every product
Typical flow for one HPLC assay, illustrative. Not a measured result.
How eSheet closes the gap
The spreadsheet’s job, without the spreadsheet
Editable formulas, macro bans, duplicate copies
Web-based forms
Calculations become validated, browser-based forms with fixed logic
A sheet per product, revalidated one by one
One template, all products
Master data from the specification drives one dynamic template
Retyping constants for every batch
Pre-populated fields
Constants, limits and standards pulled from master records
Undetected entry errors
Real-time validation
Range, logic, format and mandatory-field checks at entry
Shared drives and shared passwords
Role-based access
Analyst, reviewer and manager permissions, unique logins
No audit trail, unknown version
Audit trail and versions
Every change stamped with who, when, what and why
Print, sign, re-enter, reprint
Online review and e-signature
Send back for correction, approve with a Part 11 signature
No history across batches
Batch history and export
Every batch retrievable, trended, exported for analysis
Lost files, no recovery
Centralised database
One secure store, backed up, GAMP category 4
Features
What is in the box
Seven capabilities, each shown working. Pick one, or let them play.
Quickflow eSheet · One template, every product
One template, every product
Master data drives one validated template instead of a workbook per product.
- Specification
- 95.0–105.0 %
- Label claim
- 500 mg
- Reference standard
- WS-0412 · 99.8 %
- Sample dilution
- 1000 mL
Same template, T-ASSAY-HPLC v3. The product’s master data changes the values, not the sheet.
A Digital Scientist for your calculations
It reads the method, builds the sheet, reads every result, and you sign
Agentic AI would fill in the sheet. A Digital Scientist understands what the result means: it turns your test procedure into a calculation sheet for QA to validate, reads each result against the batches before it, and makes the case when one does not fit. A named analyst and reviewer check the reasoning, and QA signs.
1. Read the method
Digital ScientistThe test procedure, the specification and the calculation the result depends on.
2. Build the sheet
Digital ScientistInputs, formulas, rounding, data sources and checks, set out for QA to verify and validate.
3. Read every result
Digital ScientistEach result against its limits, the batches before it and the runs around it.
4. Make the case
Digital ScientistFor a result out of specification or out of trend: the likely cause, the evidence and the next step.
5. You decide
Your teamThe analyst and reviewer check the reasoning, and QA signs the conclusion.
Method to eSheet
Upload the test procedure. The calculation is mapped into a template for QA to check, instead of being built cell by cell.
Test cases included
Each formula comes with worked examples and boundary values, so validation starts from a test set, not a blank protocol.
Trends before OOS
Slow drifts inside the specification are flagged against trend limits while there is still time to act.
Phase I groundwork
For an OOS it checks the calculation, integration, weights and preparation records, and ranks what to test first.
Reasoning on the record
Every finding links to the values and records behind it, so a reviewer can follow the argument.
Nothing changes unsigned
It never alters a reported result, edits a template or closes an investigation. People do, under change control.
Every finding, recommendation and signature is in the audit trail. See the Digital Scientist Trust Charter.
Compliance built in
Inspection-ready by default
Calculation sheets are where inspectors look for data integrity gaps. With eSheet, every answer is already on the record.
- 21 CFR Part 11 audit trail
- Electronic signatures
- Role-based access
- EU Annex 11 · GAMP 5 category 4
- Web-based, any location
Mock inspection
Inspector
Illustrative records with placeholder names.
Industries
Wherever a result depends on a calculation
Across life sciences QC, from incoming material to release and stability.
Pharmaceuticals
Assay, impurity, dissolution and residual solvent calculations in finished-dose QC.
API manufacturers
In-process, release and stability calculations at every synthesis step.
Biotechnology
Potency, bioassay and protein content calculations, with results taken from the instrument.
CROs and contract labs
Calculation templates per sponsor and method, with each sponsor’s results kept separate.
CDMOs
Client-specific templates on shared methods and instruments.
Medical devices
Test and inspection calculations for incoming material and finished product.
Full overview: Calculation sheets for laboratory analysis
Most laboratories that run a LIMS and a chromatography data system still keep validated Excel sheets for complex calculations, for OOS and OOT investigations, and for method validation and transfer. Quickflow eSheet replaces those spreadsheets with validated, 21 CFR Part 11 compliant web forms fed from master data, the LIMS and the CDS.
Quickflow eSheet serve as a pivotal element in the pharmaceutical industry, providing a robust solution for automating and streamlining routine calculations performed in quality control. Aligned with the regulatory standards, Quickflow eSheets, a 21 CFR Part 11 compliant and GAMP category 4 software, is specifically designed to enhance efficiency and compliance in the realm of calculation sheets and forms. This automation not only reduces manual interactions but also establishes a secure framework that allows Quality chemists to execute processes with minimal oversight.
The significance of automating calculations in the pharmaceutical industry is underscored by the evolving role of modern chemists. At the laboratory scale, Quickflow eSheets enable chemists to test a greater number of samples with enhanced accuracy and granularity. This contributes to a more profound understanding of the chemical processes involved, fostering improved research and development outcomes.
By automating calculations, pharmaceutical companies can enhance accuracy, reduce the risk of errors, and adhere to regulatory standards. Quickflow eSheets, with their compliance-driven design, emerge as a valuable tool in the pharmaceutical landscape, supporting a seamless integration of technology and compliance to elevate the efficiency and safety of critical processes.
Laboratory
Related applications
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