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Software built for regulated operations

IT Services & Software

Software and IT support for pharmaceutical manufacturers, hospitals and laboratories — LIMS, eBMR, HMS and websites, developed and validated in-house.

GAMP 521 CFR Part 11EU GMP Annex 11ALCOA+ data integrityISO 27001 principles
Overview

What it services & software means with QCS

QCS builds and supports the software the sectors we serve actually run on. Our development team is currently delivering three products — LIMS, eBMR and HMS — alongside corporate websites and portals for pharmaceutical, hospital and laboratory clients.

Because the same team writes your validation protocols, the software is designed for the audit from day one: audit trails, user access control, electronic signatures and ALCOA+ data integrity are built in, not bolted on afterwards.

LIMS

Laboratory Information Management System — the QC laboratory from sample login to released certificate of analysis.

  • Sample login, scheduling and chain of custody
  • Specification, method and stability protocol library
  • Instrument integration and result capture
  • OOS / OOT workflow with investigation records
  • Certificate of analysis and trend reporting

eBMR

Electronic Batch Manufacturing Record — paperless execution of batch records on the production floor.

  • Recipe, BOM and master formula control
  • Step-by-step execution with electronic signatures
  • In-process checks and line clearance capture
  • Real-time deviation and yield reconciliation
  • Review-by-exception batch release

HMS

Hospital Management System — patient administration, clinical services and billing in one record.

  • Registration, OPD, IPD and ward management
  • Laboratory and radiology order-to-report flow
  • Pharmacy, store and inventory control
  • Billing, panel and insurance handling
  • Management dashboards and statutory reports

Websites

Corporate websites and portals — designed, built, hosted and maintained by the same team.

  • Corporate and product-catalogue websites
  • Customer and distributor portals
  • Search-engine optimisation and analytics
  • Domain, hosting and business email setup
  • Ongoing content updates and maintenance
Server racks lining a data centre aisleSoftware built for regulated operations
Scope of work

What is covered

Each engagement is scoped in writing before any engineer arrives on site.

01

Software development

Requirement gathering, configuration and custom development of LIMS, eBMR, HMS and web platforms against your written URS.

02

Computer system validation

CSV packages following GAMP 5 — URS, functional and design specifications, IQ/OQ/PQ and traceability matrix.

03

Data integrity & compliance

Audit trails, role-based access, electronic signatures and review workflows aligned to 21 CFR Part 11 and EU GMP Annex 11 concepts.

04

IT infrastructure

Server, network and workstation setup for laboratories and plants, including instrument connectivity and backup/restore routines.

05

Hosting & maintenance

Hosting, domain and email management, security patching, backups and annual support contracts.

06

Rollout & training

Data migration, parallel-run support, super-user and end-user training with records suitable for your training files.

What you receive

The paperwork is the product.

An engagement is not finished when the engineer leaves — it is finished when your quality unit has the records in hand.

  • URS, functional and design specifications
  • Validated release with executed IQ/OQ/PQ
  • User access matrix and audit-trail configuration
  • SOPs, user manuals and training records
  • Backup, disaster-recovery and support plan
FAQs

IT Services — common questions

We are currently delivering three products — LIMS (Laboratory Information Management System), eBMR (electronic Batch Manufacturing Record) and HMS (Hospital Management System) — alongside corporate websites and portals. All are developed, hosted and supported by our own team.

Yes. Audit trails, role-based user access, electronic signatures and review workflows are built in, aligned to ALCOA+ data integrity principles and to 21 CFR Part 11 and EU GMP Annex 11 concepts, with development following GAMP 5.

Yes. Because the same team writes your validation protocols, every implementation ships with a computer system validation package — URS, functional and design specifications, executed IQ/OQ/PQ and a traceability matrix.

Yes. LIMS supports instrument connectivity and direct result capture from analytical instruments such as HPLC, GC and balances, which removes manual transcription and the data-integrity findings that come with it.