QualificationsLine L2, at 06/11/2026
- 18 Qualified
- 4 In training
- 2 Due
Requalify before 01/12: C. Martin, S. Thomas
The Aseptic Process Simulation (APS) software
APS (media fill), operator qualification and SHT, CHT and DHT holding times (sterile, clean, dirty), brought together in one tool.
APSolute is the GMP software for sterile manufacturing sites. It provides tangible, dated and traceable evidence of aseptic control, and contributes to the Contamination Control Strategy (CCS) that EU GMP Annex 1 requires of every site.
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- 21 CFR Part 11
- EU GMP Annexes 1 and 11
- Cloud or on-premise
To do2 alerts
- 2 operators due for requalificationLine L2, in 15 daysWatch
- CHT revalidation to schedule500 L preparation tankWatch
Qualification matrixLine L2
Situation date
| Operator | Filling3 required | Interventions2 required | Set-up2 required |
|---|---|---|---|
| A.B. | 4 | 3 | 2 |
| C.M.D-25 | 3 | 1 | 2 |
| L.R. | 1 | 0 | 1 |
| S.T.D-15 | 5 | 4 | 0 |
QualifiedIn trainingNot trained
- APS and operator qualification
- Each Aseptic Process Simulation (APS, or media fill) is entered once, with attendees and activities. The qualification matrix and requalification by filling line follow from it.
- Holding times
- Every type of holding time is recorded, sterile, clean and dirty (SHT, CHT, DHT), equipment by equipment, and each validation stays in the history. Minimum and maximum durations, across all runs and over the last three, give a robust basis for setting each maximum allowable holding time and defending it in an inspection.
- Input to the CCS
- Qualifications, holding times and the audit trail form evidence that the manufacturing site adds to its CCS. Entered once, checked when saved and tracked, these data feed the CCS key performance indicators (KPIs) directly. A spreadsheet or a paper log cannot guarantee that integrity.
From master data to oversight
The site sets up its lines, equipment, activities and operators once. Every record links to them, and APSolute turns them into what you need to drive APS, holding times and the simulations ahead.
1Master data
Filling lines, equipment, activities and required levels, operators, holding time types. The site sets them up once, from its risk assessment.
2Records
Every APS with its participants and their activities, every holding time validation, links to this master data. Nothing is entered twice.
3Oversight
APSolute manages qualification status, holding time due dates and the APS to schedule, at any chosen situation date.
Holding times500 L preparation tank
- SHT41 h / 72 hCompliant
- CHT64 h / 72 hReschedule
- DHT9 h / 24 hCompliant
CHT revalidation before 18/12/2026
Upcoming APSNovember 2026 to June 2027
NDJFMAMJL1L2L3
L2 in December: 2 operators due
Illustration, sample data
What APSolute covers
The screens follow shop-floor work: enter data during operations, watch due dates, print the official document. Every status is recalculated for the as-of date you choose.
Dashboard
A to-do list grouped by area: operators due for requalification on each line, holding time revalidations overdue or coming up. Each alert is rated critical or watch, based on the notice window set by the site.
Aseptic Process Simulations
The batch record holds the filling line, start and end, calculated duration, filled, incubated and conforming units. Participants and their activities are entered on the same record.
- Consistency checks between filled, incubated and conforming units
- Batch number uniqueness per filling line
Qualification matrix
The first tier shows whether the operator took part in an APS within the year. The second compares, activity by activity, the number of APS runs performed with the required level.
- Qualified, In training, Not trained statuses
- Status as of a past date, today or any date in the future
Requalification by line
For each filling line, the due dates of every operator and the number of days left or overdue, with an alert for each of them. Operators never qualified on the line are flagged as such. This is the basis for your future planning: change the situation date to see what lies ahead.
Holding times
Every holding type, SHT, CHT and DHT, per equipment item. A cycle records its steps from sterilisation to reuse and can be linked to the start or end of an APS batch if needed. The screen compares the observed duration with the validated limit and tracks the yearly revalidation due date. The full validation history feeds the justification of maximum allowable holding times automatically, with no risk of error.
- Compliant, To reschedule, Overdue statuses
- Min and max across all runs and over the last three
Reports and official printing
APS report, statistical summary by line, qualification matrix, requalification and holding times can be viewed on screen before printing. Official printing is limited to Supervisor and Administrator levels, logged, and numbered as a controlled copy. These reports can therefore be filed directly in personnel training records.
Master data
Operators, activities, filling lines and equipment. An operator's initials are never reassigned, even after deactivation, and an activity can be restricted to specific lines or applied to all filling lines.
Audit trail
Every creation, every change and every view of a regulated screen is tracked with its author and timestamp. Changes carry field-level before and after values, and print jobs are recorded as well. Any change to records or secured items requires authorisation and is logged.
Site administration
User, Supervisor and Administrator levels, with a clear permission matrix that allows control over entered data or read-only access, depending on how the customer is organised. Named accounts are created by the administrator, with no self sign-up. Idle timeout is set per level, and the personnel qualification policy is configured to match the site's APS strategy.
Support access
Support staff work under their own identity, read-only, and change customer data only under the customer's supervision. Every intervention is timestamped, time-limited and visible in the customer's audit trail, and the customer can close access at any time.
From simulation to inspection file
Seven screens from the application, in the way a quality team uses them.
01Start with what needs doing
The dashboard lists operators due for requalification, line by line, and overdue holding time revalidations, all read at the chosen situation date.
02Record every simulation
Each APS is recorded with its filling line, start and end dates, calculated duration, and filled, incubated and conforming units.
03Know who did what
The report lists, batch by batch, the activities each participant performed. An absent participant stays visible and the report says so.
04Read the qualification matrix
For each operator and activity, the number of APS performed against the level required in the column header. An operator never qualified on the line is flagged as such.
05Plan requalification
For each operator and filling line: the last APS performed, the annual due date and the status at the situation date. A filter isolates operators due for retraining to prepare the schedule. All data can be filtered.
06Track holding times
SHT, CHT and DHT per equipment, with minimum and maximum durations across all validations and the last three, and the revalidation due date.
07Find everything in the audit trail
Logins, views of regulated screens, creations and changes: every operation is recorded with its author and timestamp, and its detail opens line by line.
APSolute compared with your current solution
Six questions inspectors actually ask, and how the tools you use answer them.
| Question | Your current solution | APSolute |
|---|---|---|
| Which qualification rule? | Rule applied with manual calculations, error-prone and hard to follow | Required level set once per activity, applied consistently with no calculation error, and ready for planning |
| Who changed what? | No reliable audit trail, uncertain document version, systematic printing for the training record | User, date, field, old and new value logged and recorded |
| Who was qualified on this line on March 1st? | Rebuilt by hand on the day of the inspection from several documents, with a risk of error | Recalculated at the situation date entered, with no calculation error |
| Is this operator qualified? | At best an “attended the APS” entry in the training record, or an attendance table kept up to date late, once the APS batch records have been interpreted | Dated participation and activities performed, with a clear qualification status for each activity |
| Is this document binding? | Printed copies to be signed and submitted to Quality Assurance | Logged PDF print, numbered as a controlled copy and signed when printed |
| Is the tracking system validated? | Rarely for this use, although Annex 11 applies to any computerised tool, tracking spreadsheets included | Designed for Annex 11 and delivered with IQ and OQ protocols drawn up under Annex 15 |
Built for inspection
21 CFR Part 11 and EU GMP Annex 11 requirements (ALCOA+ principles) are handled in the software. No bypass route is possible.
| Timestamp | User | Action | Detail |
|---|---|---|---|
| 06/11 09:12:04 | m.durand | Create | APS 26-041, line L2 |
| 06/11 09:14:37 | m.durand | Update | Incubated units: 5,200 → 5,188 |
| 06/11 09:15:02 | m.durand | Add | C. Martin, Interventions activity |
| 06/11 10:02:51 | s.bernard | View | Qualification matrix, line L2 |
| 06/11 10:04:19 | s.bernard | APS report 26-041, copy no. 3 |
Individual identification
Named accounts only. Passwords need at least 13 characters with lower case, upper case, a digit and a special character (the 80-bit threshold recommended by the French CNIL), enforced by the authentication service. Failed sign-ins are logged.
Tamper-proof audit trail
Written automatically, append-only. No application write can skip it and no screen can edit it.
Isolation between customers
Each customer sees and changes only its own data. Separation is enforced by the database itself, and an automated check verifies it at every update.
No deletion
No customer role can delete a record. Records are deactivated, and deactivation is logged like any other change. No deletion is permitted.
Reliable chronology
Synchronised server clock. Times are shown in the time zone of the manufacturing site, wherever the reader is.
Verifiable backups
Dated archive of the database, files and configuration, with a manifest and SHA-256 checksums.
APSolute provides the technical controls. Whether the software is installed on your site or used in the cloud, validating the computerised system in your context (GAMP 5, risk assessment, qualification) remains the responsibility of your site. Technical documentation (architecture, security, data model) can be shared for your file, IQ and OQ protocols are supplied, and qualification support is recommended.
Hosted for you or installed on your servers
Cloud
A3P hosts and runs the instance, so deployment is immediate. The hosted instance is qualified, and each site keeps its own administration.
On-premise
An installation on your own servers can be set up quickly. APSolute runs on a closed network with its own certificate, or behind your reverse proxy. Contact us for a quote for this type of installation.
Updates are decided with you
A new release never activates by itself. Every version change is subject to qualification and to an explicit request from the customer.
Multilingual
Interface currently in English and French, designed from the start to support our customers' languages. Each user picks a language from the sign-in screen. German, Italian, Spanish and Dutch versions are being rolled out, Nordic languages will follow, and any other language can be added within 5 days.
Masterclass 1: a tour of the modules
The modules on an empty database, with sample data entered live. For QA, production and management.
All profilesFirst sign-in and password
Sign in, replace the temporary password, pick your language.
UserRecord an APS and its participants
Batch record, filled, incubated and conforming units, then participants and activities performed.
Supervisor
Frequently asked questions
What is Aseptic Process Simulation (APS) management software?
APS management software records every Aseptic Process Simulation (media fill) and brings together the data that depend on it to manage sterility assurance. For each APS, APSolute keeps the filling line, dates, filled, incubated and conforming units, the participants and the activities they performed. It then calculates operator qualification and requalification due dates at the chosen situation date.
APS, media fill, SPA: what is the difference?
None in substance. APS (Aseptic Process Simulation) is the EU GMP Annex 1 term, media fill the common name used in industry, where the product is replaced by a growth medium, and SPA the French term. APSolute uses APS in English and SPA in French.
How does APSolute calculate operator qualification?
In two stages. First, did the operator take part in an APS on the line during the year before the situation date? If not, requalification is due. If so, APSolute shows, activity by activity, the APS in which the operator actually performed the task, counts them and compares that number with the level required by the site.
How do I track SHT, CHT and DHT holding times?
For each piece of equipment, APSolute records the validation runs for sterile (SHT), clean (CHT) and dirty (DHT) holding times. It shows minimum and maximum durations across all validations and the last three, and flags revalidations to be scheduled or overdue.
How does APSolute contribute to the site's CCS?
EU GMP Annex 1 requires every site to have a Contamination Control Strategy (CCS). APSolute does not replace it: it documents two of its parts, personnel qualification through APS and control of holding times. The calculated qualifications, the history of holding time validations and the audit trail are tangible, dated and traceable evidence that the quality system cites in its CCS and shows in inspections. Because every value is checked on entry and recorded in the audit trail, the CCS key performance indicators (KPIs), such as the share of qualified operators, overdue requalifications and holding times due for revalidation, rest on reliable data.
How do I prepare the next APS?
The Retraining screen lists, for a filling line and a date, the operators whose qualification is due. The dashboard shows these due dates line by line, so the next APS is built on a demonstrated need, with the operators who must take part.
Does APSolute meet 21 CFR Part 11 and Annex 11?
It is designed and qualified for them: named accounts, role-based rights, a tamper-proof audit trail with old and new values, and logged PDF reports as controlled copies. It comes with its installation (IQ) and operational (OQ) qualification protocols. Compliance remains that of the system validated on site.
Can APSolute be installed on site?
Yes. APSolute runs in the cloud or on the site servers (on-premise), with the same functions and the same audit trail.
Who distributes APSolute?
APSolute is distributed exclusively by the A3P association, a network for the pharmaceutical and biotech industry since 1986. Request a demo through the form on this site.
Request a demo
Tell us about your context in a few lines. We will get back to you to arrange a demo on a test database.
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contact@apsolute.fr
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