What are Laboratory Information Management Systems LIMS?

Laboratory information management systems LIMS software is used to manage data in scientific and commercial laboratories. LIMS software enables scientists and other technical personnel to track samples and specimens during each step of the analytical process, from performing tests to examining test results, to tracking control limits and quality control (QC) values. LIMS software varies by application, but is designed to help laboratories record, manage and organize large collections of data for rapid search and retrieval.

LIMS vendors offer many different types of laboratory information management systems LIMS software. Some products reflect a standard workflow that is common to many scientific and commercial laboratories. Others provide customized modeling functions that reflect client specifications. Although turnkey LIMS software is less expensive, the selection of a customized system may lengthen the LIMS implementation schedule. The proper selection of LIMS software requires a careful analysis of LIMS requirements.

Buyers need to determine data management needs, examine regulatory requirements, and inquire about integration with existing enterprise systems. Costs can be reduced if existing hardware can be reused. LIMS systems that combine third party software and laboratory information management systems LIMS software can share data accurately and integrate strategic platforms for the sharing of lab information and other electronic content.

Laboratory information management systems LIMS software enables scientific and commercial laboratories to improve various quality control QC and quality assurance QA procedures by automating activities such as entering data from instruments. Laboratory information management systems LIMS software can also be used to help laboratories achieve accreditation based on the technical requirements of ISO/IEC 17025, "General Requirements for the Competence of Testing and Calibration Laboratories". ISO is an abbreviation for the International Standards Organization ISO. IEC is an abbreviation for the International Electrotechnical Commission IEC.

What is OSHA Compliance?

The Occupational Safety and Health (OSH) Act was enacted to "assure safe and healthful working conditions for working men and women." The OSH Act created the Occupational Safety and Health Administration (OSHA) at the federal level and provided that states could run their own safety and health programs as long as those programs were at least as effective as the federal program. Enforcement and administration of the OSH Act in states under federal jurisdiction is handled primarily by OSHA. Safety and health standards related to field sanitation and certain temporary labor camps in the agriculture industry are enforced by the U.S. Department of Labor (DOL) Employment Standards Administration's Wage and Hour Division (WHD) in states under federal jurisdiction.

OSHA offers a variety of compliance assistance and outreach products and services to help employers prevent and reduce workplace fatalities, illnesses, and injuries. These include compliance assistance information, publications and tools; education and training courses; cooperative programs for organizations to collaborate with OSHA; free onsite consultation services; and the services of compliance assistance specialists who provide information and training about OSHA requirements.

The OSHA website at www.osha.gov provides information on all OSHA activities and programs, including OSHA laws and regulations, news and events, interactive software called "eTools," posters and publications, education and training programs, cooperative programs, and agency contact information.

What is GxP ?

The term GxP is a generalization of quality guidelines, predominantly used in the pharmaceutical industry.

• Good Manufacturing Practice, or GMP
• Good Engineering Practice, or GEP
• Good Laboratory Practice, or GLP
• Good Safety Practice, or GSP
• Good Clinical Practice, or GCP
• Good Distribution Practice, or GDP

GMP is the most commonly known instance of GxP. The term GxP is only used in a casual manner, to abstract from the actual set  of quality guidelines.

The purpose of the GxP quality guidelines is to ensure a quality product, guiding pharmaceutical product research,  development and manufacturing, but also presents a codex for much of the activities off the critical path.

The most central aspects of GxP are:
Traceability: the ability to reconstruct the development history of a drug.
Accountability: the ability to resolve who has contributed what to the development, and when.

Documentation is thus the most crucial instrument.

What is cGMP?

GMP refers to the Good Manufacturing Practice Regulations promulgated by the US Food and Drug Administration under the  authority of the Federal Food, Drug, and Cosmetic Act (See Chapter IV for food, and Chapter V, Subchapters  A, B, C, D, and E  for drugs and devices.) These regulations, which have the force of law, require that manufacturers, processors, and packagers  of drugs, medical devices, some food, and blood take proactive steps to ensure that their products are safe, pure, and  effective. GMP regulations require a quality approach to manufacturing, enabling companies to minimize or eliminate instances  of contamination, mixups, and errors.  This in turn, protects the consumer from purchasing a product which is not effective  or even dangerous. Failure of firms to comply with GMP regulations can result in very serious consequences including recall,  seizure, fines, and jail time.

GMP regulations address issues including recordkeeping, personnel qualifications, sanitation, cleanliness, equipment  verification, process validation, and complaint handling.

Most GMP requirements are very general and open-ended, allowing  each manufacturer to decide individually how to best implement the necessary controls. This provides much flexibility, but  also requires that the manufacturer interpret the requirements in a manner which makes sense for each individual business.

GMP is also sometimes referred to as "cGMP". The "c" stands for "current," reminding manufacturers that they must employ  technologies and systems which are up-to-date in order to comply with the regulation. Systems and equipment used to prevent  contamination, mixups, and errors, which may have been "top-of-the-line" 20 years ago, may be less than adequate by today's  standards.

What is a Clean Room?

A cleanroom is an environment, typically used in manufacturing or scientific research, that has a low level of environmental pollutants such as dust, airborne microbes, aerosol particles and chemical vapors. More accurately, a cleanroom has a controlled level of contamination that is specified by the number of particles per cubic meter and by maximum particle size.

Cleanrooms can be very large. Entire manufacturing facilities can be contained within a cleanroom with factory floors covering thousands of square meters. They are used extensively in semiconductor manufacturing, biotechnology, the life sciences and other fields that are very sensitive to environmental contamination.

The air entering a cleanroom from outside is filtered to exclude dust, and the air inside is constantly recirculated through high efficiency particulate air (HEPA) and ultra low penetration air (ULPA) filters to remove internally generated contaminants. Staff enter and leave through airlocks (sometimes including an air shower stage), and wear protective clothing such as hats, face masks, boots and cover-alls.

Equipment inside the cleanroom is designed to generate minimal air contamination. Common materials such as paper, pencils, and fabrics made from natural fibers are often excluded. Low-level cleanrooms are often not sterile (i.e., free of uncontrolled microbes) and more attention is given to airborne particles. Particle levels are usually tested using a particle counter.

Some cleanrooms are kept at a higher air pressure so that if there are any leaks, the air rushes outside. This is similar to the lower pressure used in biological hot zones to keep the microbes inside. Cleanroom HVAC systems often control the humidity to low levels, such that extra precautions are necessary to prevent electrostatic discharges. Entering a cleanroom usually requires wearing a cleanroom suit.

In cheaper cleanrooms, in which the standards of air contamination are less rigorous the entrance to the cleanroom can be without the air shower. There is an anteroom, in which the special suits have to be put on, but then a person can walk in directly to the room (as seen in the photograph on the right).

What is 21 CFR Part 11?

21 CFR Part 11 is standard that was developed in order to facilitate and encourage the wider use of technology in the manufacturing of medicinal products. Prior to August 20th 1997, all information directly relating to the manufacture of medicinal products had to be stored in hard copy. Batch records and process steps had to be manually signed (and dated) by authorised personnel. 21 CFR Part 11 defines the minimum criteria required to make electronic records and electronic signatures trustworthy, reliable and generally equivalent to handwritten documents and signatures.

There are many requirements to make a system 21 CFR Part 11 compliant and they are all spelt out in the CFR itself. In summary however the system must be able to securely and transparently handle electronic information so that it cannot be altered or doctored to falsify results without leaving an audit trail. To facilitate this, a system must be able to:

1. Log the time, date and id of person making an entry into the system (audit trail)
2. Ensure that only authorised persons can access the systems (access levels, data encryption)
3. Support two token signatures (userid and password)
4. Protect and ensure uniqueness of signatures (password database encryption and management)
5. Record and protect against unauthorised access attempts into the system.

When 21 CFR Part 11 was released in 1997, it was hailed as a landmark regulation that finally made electronic records and signatures as valid as paper records and handwritten signatures. It allows the use of electronic record-keeping systems in complying with regulations. Part 11 (also known as "Electronic Records; Electronic Signatures" or ERES) works in tandem with a predicate rule, which refers to any FDA regulation that requires organizations to maintain records.

It is not possible for any vendor to offer a turnkey 'Part 11 compliant system'. Any vendor who makes such a claim is incorrect. Part 11 requires both procedural controls (i.e. notification, training, SOPs, administration) and administrative controls to be put in place by the user in addition to the technical controls that the vendor can offer. At best, the vendor can offer an application containing the required technical requirements of a compliant system.