Validated, and staying so
Computerised systems must be validated before use and kept in a validated state through every upgrade and change, with documents an inspector can follow from requirement to test.
Industry brief
Pharmaceutical
Control systems that run every batch as approved and keep your data beyond question.
What matters
What matters most
Pharmaceutical manufacturers answer to regulators, Qualified Persons and, in the end, patients. Their control systems must run each batch as approved, keep records whose integrity is beyond question and stay validated through years of change, with every step documented for an MHRA or FDA inspector.
Data integrity
Records must be attributable, legible, contemporaneous, original and accurate, with audit trails, controlled access and electronic signatures that will stand up to an MHRA or FDA inspection.
Right first time, every batch
Every batch has to follow the approved recipe and procedure, with deviations caught, alarmed and recorded so they can be reviewed before the batch is released.
Change under control
New products, upgrades and fixes have to be introduced through your change control, without putting qualified equipment, licensed processes or the supply of medicines at risk.
Solutions
Solutions for Pharmaceutical
We work within your quality system: your validation plan, change control and document templates. Specifications trace through to tests, and our factory and site acceptance tests are written to support your IQ, OQ and PQ. Logic is proven against a simulation first, so time on site goes on qualification, not debugging.
01Batch process control and recipes
02Weighing, dispensing and blending
03Purified water and clean utilities
04CIP and SIP control
05Electronic batch records and audit trails
06Environmental and equipment monitoring
How we help
What we bring to Pharmaceutical
Standards-led, fully documented control systems that you own and can support.
Upgrades
Software and firmware upgrades
Supported software versions
In Upgrades UpgradesModifications and extensions
Extensions to existing and new systems
In Upgrades Virtual CommissioningSequence, interlock and fault testing
Every sequence and fault path tested
In Virtual Commissioning Virtual CommissioningWitnessed tests and familiarisation
Witness early, practise early
In Virtual Commissioning Code DevelopmentYour standard, your blocks
To your coding standard and block library
In Code Development Code DevelopmentGreenfield: specification to code
New systems built from the specification
In Code DevelopmentStandards
The standards that shape your project
The standards listed are those most often relevant to control-system work in this sector. Which apply to your project, and how, is agreed with you at specification stage.
| Standard | What it covers | How we work with it |
|---|---|---|
| ISPE GAMP 5 (Second Edition) | A risk-based approach to compliant GxP computerised systems, from specification to retirement. | Lifecycle documents, risk assessments and testing structured the GAMP way and scaled to each system's risk. |
| EU GMP Annex 11 and Annex 15 | GMP rules for computerised systems and for qualification and validation, applied in the UK by the MHRA. | Specifications, traceability and test evidence that fit your qualification and validation plans. |
| FDA 21 CFR Part 11 | US rules for electronic records and electronic signatures, for sites that supply the US market. | Audit trails, user access and electronic signatures configured to Part 11 where your products need it. |
| MHRA GXP Data Integrity Guidance | The MHRA's expectations for complete, consistent and accurate data, summed up as ALCOA+. | Secure, time-stamped records, audit trails and controlled access designed in from the start, not added later. |
| ISA-88 (IEC 61512) batch control | Models and terms for batch control: recipes, procedures and the equipment that runs them. | Approved recipes kept separate from equipment logic, so they change under control, not through code. |
| IEC 62443 | Security for industrial automation and control systems. | Its zone-and-conduit model shapes how we segment control networks and control remote access. |
Take it with you