Legacy system remediation
Your older instruments and workstations still produce GxP data, so they’re held to today’s expectations. We bring them up to standard with practical technical and procedural controls, without forcing a replacement you haven’t budgeted for.
Why legacy systems are hard to fix
Many instruments in QC labs and on production floors were designed before current data integrity expectations existed. Some only print to a receipt printer. Some run on operating systems the vendor stopped supporting years ago. Many were validated as standalone systems with a single shared login.
Replacing them isn’t simple. New systems mean capital spend, method transfers, revalidation and downtime, and the instrument itself often still works perfectly well. So the gaps stay open, and they show up in audits and inspections.
The good news is that most of these gaps can be closed or effectively controlled around the existing system.
What remediation looks like
A common pattern: an instrument whose results live on a shared workstation and a thermal printout. After remediation, the same instrument produces an attributable, protected electronic record that’s reviewed and backed up.
How we choose the right controls
Every remediation is matched to the system, its risk and the validation effort your team can absorb. We follow a simple order of preference:
- Technical controls first. Where the system or its environment can enforce the right behavior, we configure or build it in.
- Procedural controls where technology can’t. Clear, specific procedures and verification steps that close the remaining gaps.
- Interim controls while longer fixes land. So you can show inspectors that known risks are being actively managed today.
Validation effort is kept proportionate to risk, in line with GAMP 5 and Computer Software Assurance principles.
What we put in place
These are examples drawn from our founders’ past experience in regulated laboratories. The right combination for your site comes out of the assessment.
Capture data at the source
When an instrument can’t store or export a proper electronic record, we capture its output as close to the source as possible, so the original never depends on a piece of paper or a manual transcription.
- Capturing serial print output directly into a controlled application as an electronic record
- Controlled screen capture where an instrument offers no other export
- File uploads with a user attestation statement where manual transfer can’t be avoided
Supports Original, Accurate, Complete
Make every action attributable
Inspectors need to see who did what, and when. Where a legacy system can’t identify its users, we add attribution around it.
- Digital equipment use logs that replace paper logbooks
- Real-time second-person verification of critical entries and results
- Controlled stamps for signing and dating printouts where paper remains part of the record
Supports Attributable, Contemporaneous, Legible
Preserve the record
GxP records must stay readable and retrievable for their full retention period. Thermal receipt paper fades, local drives fail, and backups that have never been restored can’t be trusted.
- Digitizing printouts as verified true copies
- Moving away from thermal paper for records that must be retained
- Implementing and testing backup on instrument workstations
Supports Enduring, Available
Extend the life of legacy systems safely
An unsupported operating system on aging hardware is a single point of failure. Virtualizing it can remove the hardware risk and make the system easier to protect, back up and restore, while keeping the validated software intact.
- Physical-to-virtual (P2V) migration of legacy workstations
- Network isolation and access restriction for systems that can’t be patched
- Snapshot and restore procedures that are documented and tested
Supports Enduring, Available, Consistent
Make the controls stick
Controls only work if people know exactly what to do. We write procedures that are specific to your systems, not generic templates.
- Data review and verification SOPs with explicit data integrity checks
- Clear instructions for audit trail review, printout verification and handling discrepancies
- Training content aligned with the updated procedures
Supports Consistent, Complete
A typical example
A pattern our founders saw often in regulated labs, and how it’s resolved.
The situation
A QC lab relies on an older benchtop instrument whose only output is a serial-connected receipt printer. Analysts tape the printout into a notebook and transcribe the result into a spreadsheet. There’s no record of who ran the test beyond a handwritten initial.
The risk
The printout is the only original and it fades. Transcription errors go undetected. Results can’t be reliably attributed or reconstructed.
The remediation
The instrument’s serial output is captured directly into a controlled application where analysts sign in with their own credentials. Each result is stored as a protected electronic record with an audit trail and goes to a reviewer for verification. The review SOP is updated, and historical printouts are digitized as verified true copies.
The result
The instrument stays in service and its method stays validated. Its data is now attributable, protected and reviewable, and transcription has been eliminated.
Not sure which of your systems need attention?
A Data Integrity Assessment identifies your legacy system gaps and ranks them, so remediation starts where the risk is highest.