Stability Study Tracker | ICH Q1A Pull Calendar, OOS/OOT Flags & Dashboard (Excel)

Missed pulls, empty reserve shelves and trends that nobody spotted until a result failed: the Stability Study Tracker is an Excel workbook that keeps a stability programme on schedule. It is built around public concepts from ICH Q1A(R2), ICH Q1E and 21 CFR 211.166.

Enter each study once: product, batch, storage condition (25/60, 30/65, 30/75, 40/75, refrigerated, frozen), T0 date and timepoint plan. The pull calendar builds itself for 0, 3, 6, 9, 12, 18, 24 and 36 months, with a +/- day window. Each pull is flagged Scheduled, Due within 30 days, Pull now, OVERDUE, or pulled early or late.

Results are checked against the limits on the Specifications tab and flagged OOS automatically. Each attribute also gets a documented out-of-trend (OOT) check. You choose either a limit-based change from T0, or a regression prediction interval built from the earlier timepoints. Reserve inventory compares units placed with what the protocol still needs and flags a shortfall early.

The dashboard shows pulls due in 30/60/90 days, overdue pulls, OOS/OOT counts and a result-vs-time chart with the specification line. Shelf-life estimation (ICH Q1E) is out of scope. The small regression box is clearly labelled illustrative.

Built for Microsoft Excel 2019/365 (.xlsx, no macros). Tested in LibreOffice Calc. Google Sheets import possible but not officially supported.

What's included

• Stability-Study-Tracker.xlsx (8 tabs):

• Start Here: quick start, colour key, the rules behind each flag, disclaimer

• Dashboard: 12 live tiles (active studies, overdue, pull now, pulled outside window, due in 30/60/90 days, reserve shortfall, OOS, OOT, missing specs, complete), the next 10 open pulls, pulls by storage condition, and an attribute-vs-time chart with spec limits

• Study Setup (30 studies): product, batch, container closure, study type, ICH storage condition, T0, standard or custom timepoint plan, pull window, units, status and next open pull

• Pull Calendar (240 rows, automatic): scheduled date, window open/close, actual pull date, units pulled, days early/late and status

• Results (500 rows): OOS flag vs LSL/USL, change from T0, OOT flag by limit-based or regression prediction-interval method, linked investigation ID

• Specifications (50 lines): limits, unit, OOT method and allowed change per product and attribute

• Reserve Inventory: units required, pulled, unplanned withdrawals, remaining, spare after remaining pulls, shortfall flag

• Lists & Settings: drop-downs, pull window, due horizon, OOT alpha, minimum points, low-reserve threshold, plan matrix

• User-Guide.pdf (7 pages): set-up, workflow diagram, the rule behind every automatic column, OOT formulas, public references and disclaimer

• Four fictional EXAMPLE studies that trigger every flag

Who it's for

• QC, stability and analytical development teams in pharma, biotech, generics and contract labs

• Stability coordinators who schedule pulls and manage chamber inventory

• QA staff who review stability data for trends, OOS and OOT

• Small companies and start-ups that need structure before investing in a LIMS

File formats / compatibility

• .xlsx workbook. Built for Microsoft Excel 2019/365 (.xlsx, no macros). Tested in LibreOffice Calc. Google Sheets import possible but not officially supported.

• No macros, add-ins, Excel Tables, dynamic arrays or external links. Formula cells are protected without a password.

• PDF user guide (A4, 7 pages)

• Delivered as one ZIP: Rangefolio-Stability-Study-Tracker.zip

FAQ

Which programs does it work in?

Built for Microsoft Excel 2019/365 (.xlsx, no macros). Tested in LibreOffice Calc. Google Sheets import possible but not officially supported. It uses long-standing functions (INDEX/MATCH, COUNTIFS, SUMIFS, AVERAGEIFS, SUMPRODUCT, EDATE, TINV) and none of the newer dynamic-array functions.

How is OOT decided?

You choose per attribute. Limit-based: flagged when the change from the T0 result exceeds the allowed change you set. Regression: flagged when a new result falls outside the prediction interval of a least-squares line through the earlier timepoints (99% by default, minimum 3 points). Both rules are written out in the guide so you can justify or replace them in your SOP.

Does it calculate shelf life?

No. An ICH Q1E shelf-life evaluation needs confidence limits, batch-poolability tests and limits on extrapolation, so it is out of scope. The dashboard's simple regression is clearly labelled illustrative only.

Is it validated or 21 CFR Part 11 compliant?

No. It is a template and record-keeping aid, not a validated computerised system. If you keep GMP records in it, control it under your own procedures. All EX- example data is fictional; delete it before first use.

Disclaimer

Template only. Not regulatory, legal, statistical or quality advice, and not a validated computerised system (not 21 CFR Part 11 / EU GMP Annex 11 compliant on its own). Not affiliated with or endorsed by ICH, EMA, FDA or USP. All example data is fictional.