Pharmaceutical database software that links quality risk, experiment design, process validation and routine process verification across the product life cycle.
PLCS stores pharmaceutical product and process information from development through validation and routine verification. Four modules cover Criticality and Risk Assessment, Design of Experiments, Process Validation and Ongoing Process Verification. The vendor says they can operate together or separately.
Risk work links product quality targets, attributes and material or process variables. Experiment design supports screening, optimisation and models. Validation covers sampling, batch statistics and comparisons during transfer. Ongoing verification provides metrics, reports and quality dashboards.
StatSoft describes PLCS as validated under cGxP. This is a supplier statement. Current validation-pack contents, release coverage and electronic-record controls are unconfirmed. The wider systems offer describes tailored database projects and GMP services; its controls are not verified for every PLCS configuration.
Core Capabilities
FDA & GxP Compliance
PLCS is described as a database system. Manual and optional automated data entry are supported. Optional data extraction, transformation and loading is named for ongoing verification.
Cloud versus on-premise deployment, database engine, operating systems, Statistica dependency, APIs, named connectors, single sign-on, multi-factor authentication, hosting regions and scale limits are unknown.
Licence type, module entitlements, user or site limits, trial availability and public prices are unknown. Modules that can operate separately are not necessarily sold separately. Support, upgrade and third-party licence charges also require confirmation.
The wider pharmaceutical systems offer supports projects tailored to customer requirements. A standard PLCS implementation timeline, migration tool, included services and acceptance process are unknown.
Before purchase, confirm the configured modules, source data and reports. Request the current validation materials and a migration sample. These are buyer checks, not measured implementation effort.
PharmaSpotter assessment from published vendor and third-party sources. No user reviews are on file for this product.
Strengths
Independent current product-review themes are unknown.
Limitations & Open Questions
Independent current product-review complaints are unknown.
Help the community
Share your experience with StatSoft PLCS Product Life Cycle System anonymously. Your insights help pharmaceutical professionals make better software decisions.
Contribute Anonymous FeedbackJump to section